Programmatic Regulatory Reference
FDA 510(k) Clearance & Predicate Device Directory
A structured index of FDA premarket notifications built on openFDA regulatory metadata — device classifications, product codes, review panels, and 21 CFR citations — with direct links to official CDRH clearance summaries.
- Total Clearances
- 986
- Product Codes
- 456
- Review Panels
- 18
- Coverage
- 2019-09-20 – 2026-09-27
Showing 986 of 986 devices
| K-Number | Trade Name | Applicant / Sponsor | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K252139 | Kentrospine Viktr-MIS® Pedicle screw system | Rivarp Medical Pvt., Ltd. | NKB | Class II | 2026-09-27 |
| K254058 | DistaSense(TM) (v1) | Life Detection Technologies | DRT | Class II | 2026-09-25 |
| K254210 | REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) | Hyundai Bioland Co., Ltd. | NPM | Class II | 2026-09-25 |
| K254230 | CapsoView (CVV); CapsoCloud (CLD) | CapsoVision, Inc. | QZF | Class II | 2026-09-25 |
| K254252 | UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) | Karl Storz SE & CO. KG | HIH | Class II | 2026-09-25 |
| K254255 | S-Patch CardioAI | Wellysis Corp. | DPS | Class II | 2026-09-25 |
| K254291 | easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo E-Lite Single Use Cartridges | Ezisurg Medical Co., Ltd. | GDW | Class II | 2026-09-25 |
| K254297 | Tempus ECG-MR | Tempus AI, Inc. | SBQ | Class II | 2026-09-25 |
| K260023 | TumorSight Risk | SimBioSys, Inc. | SHW | Class II | 2026-09-25 |
| K260055 | syngo.CT Brain Quantification | Siemens Medical Solutions USA, Inc. | QIH | Class II | 2026-09-25 |
| K260140 | Aevice Wheeze Detection Module | Aevice Health Pte. , Ltd. | PHZ | Class II | 2026-09-25 |
| K261262 | Altis Full Face Mask | Respironics, Inc. | BZD | Class II | 2026-09-25 |
| K261336 | Xpert Respiratory Panel | Cepheid | QOF | Class II | 2026-09-25 |
| K261372 | Profoject LOR Syringe | CMT Health PTE., Ltd. | CAZ | Class II | 2026-09-25 |
| K261977 | Braun Aura 9 (6042) | Cyden Limited | OHT | Class II | 2026-09-25 |
| K261992 | 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) | Solventum US, LLC | JOJ | Class II | 2026-09-25 |
| K262196 | Invisalign System | Align Technology, Inc. | PNN | Class II | 2026-09-25 |
| K262215 | Profoject Safety Sliding Blood Collection Set | CMT Health PTE., Ltd. | JKA | Class II | 2026-09-25 |
| K262548 | EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | IYN | Class II | 2026-09-25 |
| K262975 | Arthrex Beaming System | Arthrex, Inc. | HWC | Class II | 2026-09-25 |
| K262983 | EsTemp Implant | Spident Co., Ltd. | EMA | Class II | 2026-09-25 |
| K263182 | EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2026-09-25 |
| K254199 | PicoreMax (PicoreMax) | BLUECORE COMPANY Co., Ltd. | GEX | Class II | 2026-09-24 |
| K254303 | KARL STORZ SUPRALOOP | Karl Storz SE & CO. KG | KNF | Class II | 2026-09-24 |
| K260114 | Align® Cover and Pad Guidance Tool | CIVCO Medical Instruments Co., Inc. | ITX | Class II | 2026-09-24 |
| K260214 | STA® - Liquid Anti-Xa | Diagnostica Stago, Inc. | KFF | Class II | 2026-09-24 |
| K260313 | MD-6000S Bladder Scanner | MEDA Co., Ltd. | IYO | Class II | 2026-09-24 |
| K260949 | Disposable Belts for Polysomnography (CNSAC) | CNSAC Medshop GmbH | MNR | Class II | 2026-09-24 |
| K261078 | Electric Scooter (FNS01,FNS03) | Anhui Jbh Medical Apparatus Co., Ltd. | INI | Class II | 2026-09-24 |
| K261345 | Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | HSB | Class II | 2026-09-24 |
| K262149 | corra® cervical plating system | Carlsmed, Inc. | KWQ | Class II | 2026-09-24 |
| K262168 | QIAstat-Dx BCID GN Plus AMR Panel | QIAGEN GmbH | PEN | Class II | 2026-09-24 |
| K262183 | Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60) | Shenzhen Nuon Medical Equipment Co., Ltd. | OAP | Class II | 2026-09-24 |
| K262252 | MPa Max adhesive | Den-Mat Holdings, LLC | KLE | Class II | 2026-09-24 |
| K262955 | OsseoFit Stemless Shoulder System | Zimmer, Inc. | PKC | Class II | 2026-09-24 |
| K263010 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | inomed Medizintechnik GmbH | GWF | Class II | 2026-09-24 |
| K254289 | Portable Oxygen Concentrator (OX-1A-E, OX-1B) | Oxytek Medical Technology Co., Ltd. | CAW | Class II | 2026-09-23 |
| K260117 | Everslide | Special Situations, LLC | NUC | Class II | 2026-09-23 |
| K260597 | VIRTUE QA | ProNova Solutions | LHN | Class II | 2026-09-23 |
| K260995 | DynaNail Helix® Fixation System | MedShape, Inc. | HWC | Class II | 2026-09-23 |
| K261418 | Liquick X-treme, Liquick X-treme Plus | Teleflex Medical | EZD | Class II | 2026-09-23 |
| K261453 | G7® Acetabular System | Zimmer Biomet | LPH | Class II | 2026-09-23 |
| K261637 | Single-use Flexible Bronchoscope | Hunan Vathin Medical Instrument Co., Ltd. | EOQ | Class II | 2026-09-23 |
| K261874 | Syneris PACS v.1.0.1.0 | Syneris | LLZ | Class II | 2026-09-23 |
| K261892 | ProRib Fixation System | Costa Surgical, Inc. | HRS | Class II | 2026-09-23 |
| K262067 | iFuse Granite Onyx Implant System | SI-BONE, Inc. | NKB | Class II | 2026-09-23 |
| K262144 | DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece | SETAGAYA SEIKI Co., Ltd. | EFB | Class I | 2026-09-23 |
| K262156 | Anti-HCV Next | Abbott Laboratories | MZO | Class II | 2026-09-23 |
| K262207 | Cemented Plus Abutment | Unidental Co., Ltd. | NHA | Class II | 2026-09-23 |
| K262254 | Hair Growth Comb (X-GC01) | Guangdong Ashmore Health Technology Co., Ltd. | OAP | Class II | 2026-09-23 |
| K262353 | BTL-299-F | BTL Industries, Inc. | KPI | Class II | 2026-09-23 |
| K262582 | Electric wheelchair (GP100) | Suzhou Green Pine Medical Co., Ltd. | ITI | Class II | 2026-09-23 |
| K263049 | SABER-C System | Elevation Spine | OVE | Class II | 2026-09-23 |
| K243223 | Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) | Bh Group Us, LLC | PBX | Class II | 2026-09-22 |
| K253762 | ErgoSteel (ES0001/696) | Strongback Mobility AG C/O Blueaudit GmbH | IOR | Class I | 2026-09-22 |
| K261125 | BodyTom 64 (NL4100); OmniTom Elite (NL5000) | Samsung HME America, Inc., dba NeuroLogica Corp. | JAK | Class II | 2026-09-22 |
| K262299 | Instant-View® hCG Combo II Cassette Test | Alfa Scientific Designs, Inc. | JHI | Class II | 2026-09-22 |
| K262390 | BoneXpert | Visiana | QIH | Class II | 2026-09-22 |
| K262442 | HipStudio Analysis | Replasia BV | LLZ | Class II | 2026-09-22 |
| K263054 | BIOFIRE Respiratory Panel 2.1 (RP2.1) | Biofire Diagnostics | QOF | Class II | 2026-09-22 |
| K253509 | TriSalus TriNav Advance Infusion System | Trisalus Life Sciences | KRA | Class II | 2026-09-21 |
| K254280 | F.A.S.T Screw | Steps Ortho | HWC | Class II | 2026-09-21 |
| K260416 | ZYLOX Hippo PTA Balloon Dilatation Catheter | Zylox Medtech Co., Ltd. | LIT | Class II | 2026-09-21 |
| K260512 | Disposable Ureteral Access Sheath | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | FED | Class II | 2026-09-21 |
| K260940 | BellaTek Bars | ZimVie US Corp, LLC | NHA | Class II | 2026-09-21 |
| K261368 | Rapid Platform (R6.7) | Ischemaview, Inc. | QIH | Class II | 2026-09-21 |
| K261725 | OtoCompanion (Version 1.0) | Ironsides Medical, Inc. | SHL | Class II | 2026-09-21 |
| K262108 | FAMA Male Latex Condoms Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms Aqueous Lubricant (Plain);FAMA Male Latex Condoms Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms Aqueous Lubricant (Dotted);FAMA Male Latex Condoms Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms Aqueous Lubricant (Plain);MO Male Latex Condoms Aqueous Lubricant (Ribbed);MO Male Latex Condoms Aqueous Lubricant (Dotted);MO | Shanghai Personage Hygiene Products Co., Ltd. | HIS | Class II | 2026-09-21 |
| K262109 | Access NT-proBNP | Beckman Coulter, Inc. | NBC | Class II | 2026-09-21 |
| K262547 | KARL STORZ TIPCAM1 Rubina | KALR STORZ SE & Co. KG | OWN | Class II | 2026-09-21 |
| K262982 | Core·it Dual | Spident Co., Ltd. | EBF | Class II | 2026-09-21 |
| K252723 | Dynamis Pro Family | Fotona D.O.O. | GEX | Class II | 2026-09-19 |
| K261859 | Electric Scooter (FDB08, FDB08A, FDB12) | Anhui JBH Medical Apparatus Co., Ltd. | INI | Class II | 2026-09-19 |
| K253146 | Hyperdrive 35 Guidewire | Rapid-Medical , Ltd. | DQX | Class II | 2026-09-18 |
| K253419 | Triever Duo Catheter | Inari Medical, Inc. | QEW | Class II | 2026-09-18 |
| K254238 | MINT MONO Sutures | Hans Biomed Corporation | NEW | Class II | 2026-09-18 |
| K254240 | Echo-2 | Neko Health AB | QOK | Class II | 2026-09-22 |
| K254095 | 25G Huber Needle | Martech Medical Products | PTI | Class II | 2026-09-18 |
| K254160 | VacHeal Negative Pressure Wound Therapy System | VacHeal, LLC | OKO | Class II | 2026-09-18 |
| K254171 | Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) | Shenzhen Mericonn Technology Co., Ltd. | CAF | Class II | 2026-09-18 |
| K254179 | Drainage Catheter | Canyon Medical, Inc. | FGE | Class II | 2026-09-18 |
| K260008 | Deterioration Index Version 2 | Epic Systems Corporation | QNL | Class II | 2026-09-18 |
| K261047 | Dental Diode Laser Device (Laser-Pen) | Guilin Kevin Peter Technology Co., Ltd. | GEX | Class II | 2026-09-18 |
| K261102 | UNIDRIVE Select System | Karl Storz SE & CO. KG | HIH | Class II | 2026-09-18 |
| K261229 | SCENARIA View Phase 6.0 | Fujifilm Corporation | JAK | Class II | 2026-09-18 |
| K261855 | Elucid PlaqueIQ | Elucid Bioimaging, Inc. | LLZ | Class II | 2026-09-18 |
| K262098 | EnHAnce PEEK Bunion System | Nvision Biomedical Technologies | HRS | Class II | 2026-09-18 |
| K262262 | Pathfinder Endoscope Overtube | Neptune Medical, Inc. | FED | Class II | 2026-09-18 |
| K262524 | Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) | ONE BEAUTY Technology Co., Ltd. | OHT | Class II | 2026-09-18 |
| K262532 | NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) | ICU Medical | LGZ | Class II | 2026-09-18 |
| K262599 | Biolinq Shine Autonomous Time-in-Range Microsensor | Biolinq Incorporated | SFU | Class II | 2026-09-18 |
| K262637 | SLIT LAMP SL-D4 (Type: LED) | Topcon Corporation | HJO | Class II | 2026-09-18 |
| K262817 | CrossFAST Integrated Microcatheter Advanced Delivery System | Vantis Vascular, Inc. | DQY | Class II | 2026-09-18 |
| K252995 | Durashield Device Kit | SurGenTec, LLC | GZT | Class II | 2026-09-17 |
| K254196 | HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) | Ethicon Endo-Surgery, LLC | GEI | Class II | 2026-09-17 |
| K254203 | Wearable Breast Pump (Model S36) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2026-09-17 |
| K254260 | The VEGA Cervical Screw System | GS Medical Co., Ltd. | NKG | Class II | 2026-09-17 |
| K260173 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | LZO | Class II | 2026-09-17 |
| K260677 | Vessel Closure Device (VCD177213P) | Vcd Medical S.R.L. | FZP | Class II | 2026-09-17 |
| K261266 | MOWANA Auto Duo | PENTAMASTER MEDIQ SDN BHD | FMI | Class II | 2026-09-17 |
| K261275 | Unity Total Knee System, Unity Knee Cementless CR Femur | Corin, Ltd. | MBH | Class II | 2026-09-17 |
| K261392 | TriActive Dental Implant System | Paragon Implant Mfg., LLC | DZE | Class II | 2026-09-17 |
| K261673 | LED Therapy Device (QLXY-01) | Beijing Nubway S&T Co., Ltd. | GEX | Class II | 2026-09-17 |
| K261729 | EnSite X EP System | Abbott Medical | DQK | Class II | 2026-09-17 |
| K261817 | Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | GEX | Class II | 2026-09-17 |
| K261869 | Integrity Retractable Implant Inserter (6000127) | Anika Therapeutics, Inc. | MBI | Class II | 2026-09-17 |
| K261959 | Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102) | Stryker Instruments | GEI | Class II | 2026-09-17 |
| K262073 | Hygienic Protective Bite Cover (2207-010-50) | Dürr Dental SE | PEM | Class II | 2026-09-17 |
| K262091 | FRAXION Spinal Fixation System | Ortler Global Tibbi Gerecler Anonim Sirketi | NKB | Class II | 2026-09-17 |
| K262495 | Miru 1day UpSide (midafilcon A) | Menicon Co, Ltd. | LPL | Class II | 2026-09-17 |
| K262913 | Protégé EverFlex Self-expanding Peripheral Stent System | Medtronic, Inc. | FGE | Class II | 2026-09-17 |
| K254142 | Dia-X Sil Heavy Body | DiaDent Group International | ELW | Class II | 2026-09-16 |
| K254152 | Dia-X Sil Light Body | DiaDent Group International | ELW | Class II | 2026-09-16 |
| K254181 | Aristotle 65 Macrowire | Scientia Vascular | MOF | Class II | 2026-09-16 |
| K254212 | NC PTA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | LIT | Class II | 2026-09-16 |
| K260220 | Route 92 Medical Full Length 046 Access System | Route 92 Medical, Inc. | QJP | Class II | 2026-09-16 |
| K260226 | ElintMAX Respiratory Monitor (ElintMAX Monitor A1) | Amptron Medical, Inc. | BZK | Class II | 2026-09-16 |
| K260309 | Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set | Ambu A/S | EOQ | Class II | 2026-09-16 |
| K260906 | a2z-Abdo-Triage | A2z Radiology Ai, Inc. | QAS | Class II | 2026-09-16 |
| K261283 | APERTO Lucent MRI System | Fujifilm Corporation | LNH | Class II | 2026-09-16 |
| K261370 | LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) | Guangdong Newdermo Biotech Co., Ltd. | NFO | Class II | 2026-09-16 |
| K261400 | Ambu® aScope Gastro; Ambu® aScope Gastro Large | Ambu A/S | FDS | Class II | 2026-09-16 |
| K261467 | GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) | Gt Metabolic Solutions, Inc. | SAH | Class II | 2026-09-16 |
| K261623 | EchoPAC Software Only / EchoPAC Plug-in (v211) | GE Medical Systems Ultrasound and Primary Care Diagnostics | QIH | Class II | 2026-09-16 |
| K261712 | Ceribell EEG Analysis Software | Ceribell, Inc. | OLT | Class II | 2026-09-16 |
| K261758 | Embrace Vision Neonatal MRI System | Aspect Imaging, Ltd. | LNH | Class II | 2026-09-16 |
| K261778 | JADE SCORE PTA Scoring Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | PNO | Class II | 2026-09-16 |
| K261865 | AerFrame Alignment Laser Box (LBV2) | Stabilix, LLC | IYE | Class II | 2026-09-16 |
| K261888 | ClearClub Impression Material | ClearClub | SHI | Class II | 2026-09-16 |
| K261896 | iOS CamAPS FX | CamDiab | QJI | Class II | 2026-09-16 |
| K261913 | X°Port Heart Preservation System | Traferox Technologies, Inc. | MSB | Class II | 2026-09-16 |
| K261919 | Multifunctional wheelchair (YJ-059) | Zhenjiang Assure Medical Equipment Co., Ltd. | IOR | Class I | 2026-09-16 |
| K262054 | Electric Wheelchair | Yongkang Joymax Medical Technology Co., Ltd. | ITI | Class II | 2026-09-16 |
| K262877 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Olympus Surgical Technologies America | GEX | Class II | 2026-09-16 |
| K254214 | OOOPDS | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | LLZ | Class II | 2026-09-15 |
| K254299 | CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) | Karl Storz SE & CO. KG | EOB | Class II | 2026-09-15 |
| K260141 | Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C) | Zhenjiang Assure Medical Equipment Co., Ltd. | IOR | Class I | 2026-09-15 |
| K260144 | Reclining wheelchair (YJ-013L) | Zhenjiang Assure Medical Equipment Co., Ltd. | IOR | Class I | 2026-09-15 |
| K260145 | YJ-K1K2 Wheelchair (YJ-013F) | Zhenjiang Assure Medical Equipment Co., Ltd. | IOR | Class I | 2026-09-15 |
| K260446 | Tontarra Punches and Rongeurs | Tontarra Medizintechnik GmbH | HAE | Class II | 2026-09-15 |
| K261070 | LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated | Covidien, LLC | GEI | Class II | 2026-09-15 |
| K261447 | CVAC® Aspiration System | Calyxo, Inc. | FGB | Class II | 2026-09-15 |
| K261677 | Artificial Intelligence Renal Assessment (AIRA) Version 1 | Aramis Global AI Consultancies, LLC | QIH | Class II | 2026-09-15 |
| K261861 | SPINEsim v1.0 | Mdsim S.A. | LLZ | Class II | 2026-09-15 |
| K262057 | GMK Extension | Medacta International SA | JWH | Class II | 2026-09-15 |
| K262963 | TMC Implant Fixation System | Treace Medical Concepts, Inc. | HRS | Class II | 2026-09-15 |
| K253481 | colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) | Ovesco Endoscopy AG | PKL | Class II | 2026-09-14 |
| K260781 | Yumizen H550 | HORIBA ABX SAS | GKZ | Class II | 2026-09-14 |
| K260795 | Hand-held Dental X-ray System (HyperLight-M) | Changzhou Sifary Medical Technology Co., Ltd. | EHD | Class II | 2026-09-14 |
| K261089 | Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit | Maduro Medical, Inc. | NRY | Class II | 2026-09-14 |
| K261438 | HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) | Eurosets S.R.L | DTZ | Class II | 2026-09-14 |
| K261517 | qCT Lung (v1.0) | Qure.Ai Technologies Pvt. , Ltd. | QDQ | Class II | 2026-09-14 |
| K262163 | BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth | Becton Dickinson and Company | JTZ | Class II | 2026-09-14 |
| K262193 | RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology | Xenix Medical | NKB | Class II | 2026-09-14 |
| K262526 | Safety lancet (XL) | Tianjin Huahong Technology Co., Ltd. | FMK | Class II | 2026-09-13 |
| K260133 | CADDIE | Odin Medical Limited | QNP | Class II | 2026-09-12 |
| K261287 | Digistat Care | Ascom Ums Srl Unipersonale | MSX | Class II | 2026-09-12 |
| K254051 | Extroducer Infusion Catheter System | SmartWise Sweden AB | KRA | Class II | 2026-09-11 |
| K254072 | BoneVue | Curvebeam AI / Curvebeam, LLC | KGI | Class II | 2026-09-11 |
| K254123 | Ecomed Disposable Administration Sets | Ecomed Solutions, LLC | FPA | Class II | 2026-09-11 |
| K260001 | Mint ACE Pump | Beta Bionics, Inc. | QFG | Class II | 2026-09-11 |
| K260063 | GSPE Spacer | The General Hospital Corporation, d/b/a Massachusetts | JWH | Class II | 2026-09-11 |
| K260410 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., Ltd. | FED | Class II | 2026-09-11 |
| K261019 | ANTERION | Heidelberg Engineering GmbH | OBO | Class II | 2026-09-11 |
| K261255 | KOWA FM-600 | Kowa Company, Ltd. Chofu Factory | MYC | Class II | 2026-09-11 |
| K261305 | MICSI-PET | Microstructure Imaging, Inc. | KPS | Class II | 2026-09-11 |
| K261338 | RENASYS DYNAFLOW Kit (66807741) | Smith & Nephew Medical, Ltd. | OMP | Class II | 2026-09-11 |
| K261580 | ZBPro Diagnostic (Version 2.0) | Zbeats, Inc. | MLO | Class II | 2026-09-11 |
| K261807 | Sequential Circulator (SC-4004-DL, SC-4008-DL) | Bio Compression Systems, Inc. | JOW | Class II | 2026-09-11 |
| K261837 | FINDER Flu A&B/SARS-CoV-2 Test | Baebies, Inc. | QOF | Class II | 2026-09-11 |
| K262007 | PRIMED AAMI Level 3 Open Back Gowns | PRIMED Medical Products, Inc. | QPC | Class II | 2026-09-11 |
| K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System | INNO Holdings Inc. DBA Innovasis | OVD | Class II | 2026-09-11 |
| K262050 | Vioseal X | Spident Co., Ltd. | KIF | Class II | 2026-09-11 |
| K262151 | SpaceOAR Flex System | Boston Scientific Corporation | OVB | Class II | 2026-09-11 |
| K262230 | Mg OSTEOREVIVE;Mg OSTEOCRETE | Bone Solutions, Inc. | MQV | Class II | 2026-09-11 |
| K262397 | CuratOR EX2742 | Eizo Corporation | GCJ | Class II | 2026-09-11 |
| K262763 | iLet Dosing Decision Software | Beta Bionics, Inc. | QJI | Class II | 2026-09-11 |
| K262861 | PureLift Pro Max | Xtreem Pulse, LLC | NFO | Class II | 2026-09-11 |
| K262874 | CraniUS Plate | CraniUS, LLC | GWO | Class II | 2026-09-11 |
| K254111 | Irrigation/Urology Sets | B.Braun Medical, Inc. | LJH | Class II | 2026-09-10 |
| K254119 | Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303) | Shenzhen Xinyan Medical Technology Co.,ltd. | MWJ | Class II | 2026-09-11 |
| K254174 | Surgical Power System | Guizhou Zirui Technology Co., Ltd. | HBC | Class II | 2026-09-11 |
| K254177 | Disposable Sterile Skull Drill (LZ) | Guizhou Zirui Technology Co., Ltd. | HBF | Class II | 2026-09-11 |
| K254185 | Potenza Prime | Jeisys Medical Incorporated | GEI | Class II | 2026-09-11 |
| K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. | HAW | Class II | 2026-09-10 |
| K254009 | Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV) | Lakong Medical Devices Co., Ltd. | SJH | Class I | 2026-09-10 |
| K254074 | TruPress | Procerus Enterprises | DRS | Class II | 2026-09-10 |
| K254246 | LT Antibacterial Foam with Silver Dressing | Zhejiang Longterm Medical Technology Co., Ltd. | NAD | Class I | 2026-09-10 |
| K260110 | danumed Extension Set for Gastrostomy Button | Danumed Medizintechnik GmbH | PIF | Class II | 2026-09-10 |
| K260879 | 4DM | INVIA, LLC | QIH | Class II | 2026-09-10 |
| K261562 | Diode Laser Therapy System | Sanhe LEFIS Electronics Co., Ltd. | GEX | Class II | 2026-09-10 |
| K261696 | ACUNAV Luxera 4D ICE Catheter | Siemens Medical Solutions USA, Inc. | OBJ | Class II | 2026-09-10 |
| K261795 | Quicktome Software Suite | Omniscient Neurotechnology Pty, Ltd. | QIH | Class II | 2026-09-10 |
| K261929 | Upper Arm Blood pressure monitor (BP7155D) | OMRON Healthcare, Inc. | DXN | Class II | 2026-09-10 |
| K262079 | 4K Camera Head OLYMPUS CH-S700-08-LB | Olympus Medical Systems Corp. | FET | Class II | 2026-09-10 |
| K262202 | Cerasmart Forte | GC America, Inc. | EBF | Class II | 2026-09-10 |
| K251417 | ReVISION 2 | Argus Cognitive, Inc. | QIH | Class II | 2026-09-09 |
| K252486 | ChestView US (1.1) | Gleamer | MYN | Class II | 2026-09-09 |
| K254294 | Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30) | Zhejiang Geyi Medical Instrument Co., Ltd. | HIH | Class II | 2026-09-08 |
| K260053 | Power Wheelchair (OS-R-M01I) | Beijing OrionStar Technology Co., Ltd. | ITI | Class II | 2026-09-08 |
| K260062 | MODI System | DreaMed Diabetes, Ltd. | QRX | Class II | 2026-09-08 |
| K254135 | LipoSurg ARTIST | NOUVAG AG | QPB | Class II | 2026-09-05 |
| K253836 | FCT iStream Phase 2 | Fujifilm Corporation | JAK | Class II | 2026-09-04 |
| K253909 | NeoPEX Pre-Mixed Obturation Paste | NuSmile, Ltd. | KIF | Class II | 2026-09-04 |
| K254262 | Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA | Ortho Clinical Diagnostics Inc. (QuidelOrtho) | PSZ | Class II | 2026-09-04 |
| K254264 | Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | QVF | Class II | 2026-09-04 |
| K260035 | Digital Indeflator INFLANTE | UAB Telemedicina | MAV | Class II | 2026-09-04 |
| K262292 | Gastric Alimetry | Alimetry , Ltd. | MYE | Class II | 2026-09-04 |
| K262293 | EVOLUTION MPX Total Knee System | Suzhou Microport Orthorecon Co., Ltd. | JWH | Class II | 2026-09-10 |
| K262426 | Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) | Wuhan Pioon Technology Co., Ltd. | GEX | Class II | 2026-09-10 |
| K260997 | SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01) | Endoclot Plus Co., Ltd. | PLL | Class II | 2026-09-09 |
| K261470 | QF10 | E.A.M Benelux B.V | NHV | Class II | 2026-09-09 |
| K261793 | Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color) | Maxter Healthcare, Inc. | LZA | Class I | 2026-09-09 |
| K262488 | Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3) | Guangzhou Red Pine Medical Instrument Co., Ltd. | FGB | Class II | 2026-09-09 |
| K262542 | Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim | Top Glove Sdn. Bhd. | LZA | Class I | 2026-09-09 |
| K260227 | EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H | DRTECH Corporation | KPR | Class II | 2026-09-08 |
| K260229 | Electric wheelchair (HC819N, HC830N, HC831N) | Yongkang Hengyi Vehicle Co., Ltd. | ITI | Class II | 2026-09-08 |
| K260312 | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid | Gmp Medicare Sdn. Bhd. | LZA | Class I | 2026-09-08 |
| K261462 | LANDMARK Total Knee System | Smith & Nephew, Inc. | MBH | Class II | 2026-09-08 |
| K261715 | Emboliner Embolic Protection System (EPC-03) | Emboline, Inc. | PUM | Class II | 2026-09-08 |
| K261823 | da Vinci Surgical System, Model IS5000 | Intuitive Surgical, Inc. | NAY | Class II | 2026-09-08 |
| K261956 | Dental Barriers and Sleeves (AB0006) | ANI Co., Ltd. | PEM | Class II | 2026-09-08 |
| K261987 | Reusable SmartPeg | Osstell AB | EKX | Class I | 2026-09-08 |
| K262173 | N22 Offset Humeral Head | Shoulder Innovations, Inc. | KWT | Class II | 2026-09-08 |
| K262341 | b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions | B-One Ortho, Corp. | JWH | Class II | 2026-09-08 |
| K260396 | KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A) | Fidelity BioPharma Co. | OBP | Class II | 2026-09-06 |
| K261131 | Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.) | Shenzhen Osto Medical Technology Co.,Ltd | NUH | Class II | 2026-09-06 |
| K260331 | IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) | Siemens Healthcare Diagnostics Products, Ltd. | DHB | Class II | 2026-09-04 |
| K260525 | NextMR Spine | MRI2CT, Inc. | QIH | Class II | 2026-09-04 |
| K260756 | TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) | Sentinel Medical Technologies, | EZL | Class II | 2026-09-04 |
| K261057 | ActivaScrew Cannulated COM | Bioretec, Ltd. | HWC | Class II | 2026-09-04 |
| K261935 | Surgical and Prosthetic Trays | Dentsply Sirona, Inc. | KCT | Class II | 2026-09-04 |
| K262060 | 3D-RD-S | Radiopharmaceutical Imaging & Dosimetry, LLC | LLZ | Class II | 2026-09-04 |
| K262130 | ATTUNE Revision Knee System | Depuy Orthopaedics, Inc. | JWH | Class II | 2026-09-04 |
| K262235 | ApexCut Blade with Automated EM Tracking (187BL4012EM);ApexCut Blade with Automated EM Tracking (187BL4040EM);ApexCut Blade with Automated EM Tracking (187BL4060EM);ApexCut Blade with Automated EM Tracking (187BL2975EM);ApexCut Blade with Automated EM Tracking (187BL3590EM);ApexCut Blade with Automated EM Tracking (187BL4000LEM) | Medtronic Xomed, Inc. | PGW | Class II | 2026-09-04 |
| K262277 | 70 NeuGlide Catheter | Piraeus Medical, Inc. | QJP | Class II | 2026-09-04 |
| K251794 | Tenax® Laser Resistant Endotracheal Tube | Bryan Medical, Inc. | BTR | Class II | 2026-09-03 |
| K253673 | Mcare System (MW-20) | Marani Health, Inc. | LQK | Class II | 2026-09-03 |
| K253948 | Momentum Acetabular Cup System | United Orthopedic Corporation | LZO | Class II | 2026-09-02 |
| K262809 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | MBI | Class II | 2026-09-02 |
| K262828 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | NKB | Class II | 2026-09-04 |
| K260503 | Triton 1 System | Neptune Medical, Inc. | FDF | Class II | 2026-09-03 |
| K261281 | CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 | Filmecc Co., Ltd. | DQX | Class II | 2026-09-03 |
| K261622 | Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62) | Philips Consumer Lifestyle B.V. | HGX | Class II | 2026-09-03 |
| K261647 | Tempo Plating System; Ultra Compression Screw System | Pace Surgical | HRS | Class II | 2026-09-03 |
| K261800 | Helo Max Thrombectomy System (HEL2090) | Endovascular Engineering | QEW | Class II | 2026-09-03 |
| K262243 | Profisil Free | Kettenbach GmbH & Co. KG | LBH | Class II | 2026-09-03 |
| K262315 | NeuroBlate System | Monteris Medical | ONO | Class II | 2026-09-03 |
| K262460 | Rezum System | Boston Scientific | KNS | Class II | 2026-09-03 |
| K260432 | Ruby Intravascular Catheter | Venocare, Inc. | FOZ | Class II | 2026-09-02 |
| K261313 | Vivid Explorer/Vivid Advanced/Vivid Focus | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2026-09-02 |
| K261589 | 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | GEX | Class II | 2026-09-02 |
| K261749 | Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Cardinalhealth | LZA | Class I | 2026-09-02 |
| K262153 | Pivot Insulin Delivery System | Modular Medical, Inc. | LZG | Class II | 2026-09-02 |
| K262364 | Ellian Enigma RF Device | Ellian Corp | GEI | Class II | 2026-09-02 |
| K262420 | Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) | Serpex Medical | GEH | Class II | 2026-09-02 |
| K253961 | SK Knee System | Just Medical Devices (Tianjin) Co., Ltd. | JWH | Class II | 2026-09-01 |
| K260613 | AMI Plasma Cartridge, AMI | Sequitur Health Corp. | JID | Class I | 2026-09-01 |
| K260656 | Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M | GE Healthcare Finland Oy | MHX | Class II | 2026-09-01 |
| K260758 | MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Shenzhen Magnetic Resonance , Ltd. | LNH | Class II | 2026-09-01 |
| K260884 | UNIDRIVE Select System | Karl Storz SE & CO. KG | GCJ | Class II | 2026-09-01 |
| K261811 | PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3) | PRIMED Medical Products, Inc. | QSO | Class II | 2026-09-01 |
| K262269 | CO2 Laser System (MBT- CO2 Laser) | Beijing Mega Beauty Technology Co., Ltd. | GEX | Class II | 2026-09-01 |
| K262451 | Arthrex DynaNite Staples | Arthrex, Inc. | JDR | Class II | 2026-09-01 |
| K262774 | Wearable breast pump (Model: XN/MD-2249BS, ZFHF) | Guangdong Horigen Mother & Baby Products Co., Ltd. | HGX | Class II | 2026-09-01 |
| K262783 | RadiForce MX247W | Eizo Corporation | PGY | Class II | 2026-09-01 |
| K260387 | SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003) | Hironic Co., Ltd. | NFO | Class II | 2026-08-31 |
| K260488 | MULTIX Impact; MULTIX Impact C | Siemens Medical Solutions USA, Inc. | KPR | Class II | 2026-08-31 |
| K260767 | Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907) | Kam Yuen Plastic Products , Ltd. | OHS | Class II | 2026-08-31 |
| K261403 | Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter | Global Life Sciences Solutions USA, LLC | FPB | Class II | 2026-08-31 |
| K261695 | Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) | Guilin Kevin Peter Technology Co., Ltd. | EBF | Class II | 2026-08-31 |
| K261718 | EZFluence (RADEZ V2) | Radformation, Inc. | IYE | Class II | 2026-08-31 |
| K262658 | Automatic Digital Blood Pressure monitor (LD-526) | Honsun (Nantong) Co., Ltd. | DXN | Class II | 2026-08-31 |
| K262747 | ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 | Abbott Diagnostics Scarborough, Inc. | OCC | Class II | 2026-08-31 |
| K262788 | Nova HD+ | Aura Wellness, LLC | SGT | Class II | 2026-08-31 |
| K253630 | Mpact 3D Metal Foam | Medacta International S.A. | LPH | Class II | 2026-08-28 |
| K253954 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | QRY | Class II | 2026-08-28 |
| K254261 | Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK) | CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD. | MQL | Class II | 2026-08-28 |
| K260045 | cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190) | Roche Molecular Systems, Inc. | OZN | Class II | 2026-08-28 |
| K260047 | cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190) | Roche Molecular Systems, Inc. | PGX | Class II | 2026-08-28 |
| K260203 | Fule Vertebroplasty Balloon Catheter | Beijing Fule Science & Technology Development Co., Ltd. | HRX | Class II | 2026-08-28 |
| K260343 | Carescape Canvas 1000; Carescape Canvas Smart Display | GE Healthcare Finland Oy | MHX | Class II | 2026-08-28 |
| K260517 | Automatic Core Biopsy Instrument | Zhejiang Curaway Medical Technology Co., Ltd. | KNW | Class II | 2026-08-28 |
| K260617 | Tigertriever 13 Ultra Revascularization Device | Rapid Medical Ltd. | NRY | Class II | 2026-08-28 |
| K261176 | Zoom 4S Catheter | Imperative Care, Inc. | QJP | Class II | 2026-08-28 |
| K261378 | Rayvolve AZchest | AZmed | QBS | Class II | 2026-08-28 |
| K261582 | Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | NUV | Class II | 2026-08-28 |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog) | Ortler Global Tibbi Gerecler Anonim Sirketi | HRS | Class II | 2026-08-28 |
| K262013 | Kiba CTO Crossing Catheter | Reflow Medical, Inc. | PDU | Class II | 2026-08-28 |
| K262722 | Primal K-Wire (P99-193-1410) | Paragon 28, Inc. | HTY | Class II | 2026-08-28 |
| K262735 | LINQ II Insertable Cardiac Monitor (ICM) (LNQ22) | Medtronic, Inc. | MXD | Class II | 2026-08-28 |
| K253859 | Scarlet Pro (Scarlet Pro) | VIOL Co., Ltd. | GEI | Class II | 2026-08-27 |
| K260401 | EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F) | Olympus Medical Systems Corporation | PSV | Class II | 2026-08-27 |
| K260481 | GC85A | Samsung Electronics Co., Ltd. | KPR | Class II | 2026-08-27 |
| K260545 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System | Ascensia Diabetes Care | NBW | Class II | 2026-08-27 |
| K260751 | 35 Helix Guidewire | Piraeus Medical, Inc. | MOF | Class II | 2026-08-27 |
| K260824 | Gastrointestinal Videoscope Olympus GIF-2T1500 | Olympus Medical Systems Corporation | FDS | Class II | 2026-08-27 |
| K260856 | Disposable Distal Attachment D-201-13404 | Olympus Medical Systems Corporation | FDS | Class II | 2026-08-27 |
| K261360 | EasyCare Tx 2 | Resmed Corp | MOD | Class II | 2026-08-27 |
| K261802 | Glidewell Denture Base Resin | Prismatik Dentalcraft, Inc. | EBI | Class II | 2026-08-27 |
| K261821 | 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | GEX | Class II | 2026-08-27 |
| K262104 | Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT) | Ram.Shaw Pte., Ltd. | LRK | Class II | 2026-08-27 |
| K262268 | Optiflow Oxygen Kit (AA484J) | Fisher and Paykel Healthcare Limited | BTT | Class II | 2026-08-27 |
| K262654 | Dexus Prosthetic System (MSL2, MSR2) | Zhejiang Qiangnao Technology Co.,Ltd | GXY | Class II | 2026-08-27 |
| K262677 | Iconix Knotless T | Riverpoint Medical | MBI | Class II | 2026-08-27 |
| K262744 | GenesisX RMN | Stereotaxis, Inc. | DXX | Class II | 2026-08-27 |
| K253715 | Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279) | Maquet Critical Care AB | PIF | Class II | 2026-08-26 |
| K253877 | StimTrial Neuromodulation System | Bioventus, LLC | GZF | Class II | 2026-08-26 |
| K254103 | HOPKINS Telescopes for Arthroscopy | Karl Storz SE & CO. KG | HRX | Class II | 2026-08-26 |
| K260407 | Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns | Principle & Will Co., Ltd. | FYA | Class II | 2026-08-26 |
| K260733 | MRIA Radiation Therapy Information System (MRIA) | Manteia Technologies Co., Ltd. | IYE | Class II | 2026-08-26 |
| K260811 | Heartvue.Proton | Heartvue.ai, Inc. | QIH | Class II | 2026-08-26 |
| K260972 | OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor | Sony Corporation | GCJ | Class II | 2026-08-26 |
| K261142 | Ponto 5 Mini; Ponto 5 Superpower | Oticon Medical AB | MAH | Class II | 2026-08-26 |
| K261153 | LithoVue Elite Digital Flexible Ureteroscope System | Boston Scientific Corporation | FGB | Class II | 2026-08-26 |
| K261394 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus) | JOYTECH Healthcare Co., Ltd. | DXN | Class II | 2026-08-26 |
| K262581 | GraftGun Universal Graft Delivery System (GDS®) | SurGenTec, LLC | FMF | Class II | 2026-08-26 |
| K262595 | VariLift-C Cervical Interbody Fusion System | Wenzel Spine, Inc. | ODP | Class II | 2026-08-26 |
| K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle Tray | Sol-Millennium Medical, Inc. | FMF | Class II | 2026-08-25 |
| K252535 | Inno-Switch Laparoscopic Instruments | Taiwan Surgical Corporation | GEI | Class II | 2026-08-25 |
| K253879 | MONOFIX PDO | Samyang Holdings Corporation | NEW | Class II | 2026-08-25 |
| K254304 | iNOS intraoral biosensor | Achaemenid, LLC | PLC | Class II | 2026-08-25 |
| K261514 | Calcium Hydroxide Temporary Filling Material (KP-Cal) | Guilin Kevin Peter Technology Co., Ltd. | KIF | Class II | 2026-08-25 |
| K261595 | Ceevra Reveal 4 | Ceevra, Inc. | QIH | Class II | 2026-08-25 |
| K261719 | Promisemed X-Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | FMI | Class II | 2026-08-25 |
| K261747 | Report Studio | Beacon Biosignals, Inc. | OLV | Class II | 2026-08-25 |
| K262631 | Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) | SteriLance Medical (Suzhou), Inc. | QRK | Class II | 2026-08-25 |
| K253515 | Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments | Biomet Orthopedics, Inc. | JDI | Class II | 2026-08-24 |
| K254286 | Guided Bone Regeneration System | DentalMaster(Xiamen)Medical Technology Co., Ltd. | DZL | Class II | 2026-08-24 |
| K260106 | OsteoCoil GT Active Compression System | Flower Orthopedics Corporation DBA Conventus Flower Orthoped | HWC | Class II | 2026-08-24 |
| K260246 | SEISMIQ Intravascular Lithotripsy System | Bolt Medical, Inc. | PPN | Class II | 2026-08-24 |
| K260604 | BiWaze Clear System | Abmrc, LLC | NHJ | Class II | 2026-08-24 |
| K261381 | TiLink-L SI Joint Fusion System | SurGenTec, LLC | OUR | Class II | 2026-08-24 |
| K260691 | BTL-699 | BTL Industries, Inc. | OBP | Class II | 2026-08-23 |
| K253910 | Stitch - Suture Wires and Tapes | GM Dos Reis Industria e Comercio Ltda. | GAT | Class II | 2026-08-22 |
| K253692 | AVVIGO+ Multi-Modality Guidance System | Boston Scientific | DQK | Class II | 2026-08-21 |
| K253699 | Tempus ECG-PH | Tempus AI, Inc. | SAT | Class II | 2026-08-21 |
| K253726 | uAngio AVIVA CX | Shanghai United Imaging Healthcare Co., Ltd. | OWB | Class II | 2026-08-21 |
| K253728 | EVOLUTION® AM BIOFOAM® Tibial System | Microport Orthopedics, Inc. | MBH | Class II | 2026-08-21 |
| K253817 | IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La | Immunodiagnostics Systems Limited | LLL | Class II | 2026-08-21 |
| K261015 | Solo Scope Colonoscope System | Gi View, Ltd. | FDF | Class II | 2026-08-21 |
| K261354 | Electric wheelchair (D03) | Foshan Sowell Medical Technology Co., Ltd. | ITI | Class II | 2026-08-21 |
| K253807 | Valence InVent Xtend (CVG-4101-VXA) | Convergence Medical Sciences , Ltd. | MOD | Class II | 2026-08-20 |
| K260242 | CPETWise Platform | Medibyt , Ltd. | BTY | Class II | 2026-08-20 |
| K260579 | Infinity® Acute Care System (IACS) VG8.1 | Draeger Medical Systems, Inc. | MHX | Class II | 2026-08-20 |
| K260584 | BoneMRI | Mriguidance B.V. | QIH | Class II | 2026-08-21 |
| K260643 | Cimilre Dual Max | Cimilre Co., Ltd. | HGX | Class II | 2026-08-21 |
| K261466 | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM | Zeus Scientific | MOB | Class II | 2026-08-21 |
| K261710 | AYON Power Liposuction Cannulas and AYON Power Liposuction Cannula Adaptors | Apyx Medical Corporation | QPB | Class II | 2026-08-21 |
| K261882 | Pisces-SC Standalone Cervical Interbody System | Osseus Fusions Systems, LLC | OVE | Class II | 2026-08-21 |
| K262005 | Affera Integrated Mapping System | Medtronic, Inc. | DQK | Class II | 2026-08-21 |
| K262074 | Any-Zircos | Mediclus Co., Ltd. | EIH | Class II | 2026-08-21 |
| K262089 | Disposable Warming Blanket | Hangzhou Tappa Medical Technology Co., Ltd. | DWJ | Class II | 2026-08-21 |
| K262127 | DS Core CBCT Anatomy | Dentsply Sirona | QIH | Class II | 2026-08-21 |
| K262538 | Artix MT;Artix Thin-Walled Sheath | Inari Medical, Inc. | QEW | Class II | 2026-08-21 |
| K260817 | MIRA Surgical System | Virtual Incision | SAB | Class II | 2026-08-20 |
| K261049 | SCALA® TL | Spineart SA | MAX | Class II | 2026-08-20 |
| K261298 | Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) | Guangdong Youmeng Electrical Technology Co., Ltd. | HGX | Class II | 2026-08-20 |
| K262113 | HardyDisk AST Tebipenem 10µg (TBP10) | Hardy Diagnostics | JTN | Class II | 2026-08-20 |
| K262506 | Remex Spine Surgery Navigation - Universal Instruments | Remex Medical Corp. | OLO | Class II | 2026-08-20 |
| K262515 | Kneu Platform (V2) | Kneu Health Digital , Ltd. | GYD | Class II | 2026-08-20 |
| K260209 | ENDOFLATOR+; Smart Smoke Evacuation | Karl Storz SE & CO. KG | HIF | Class II | 2026-08-19 |
| K260463 | ZEROS Dental Implant System | Zeros Co., Ltd. | DZE | Class II | 2026-08-19 |
| K260799 | Nipro Dry Acid Concentrate Mixer | Nipro Technical Solutions, Incoporated | KPO | Class II | 2026-08-19 |
| K261083 | Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK) | CooperSurgical, Inc. | MQG | Class II | 2026-08-19 |
| K261686 | Elecsys Phospho-Tau (217P) Plasma | Roche Diagnostics | SET | Class II | 2026-08-19 |
| K261964 | ECHOLASER X4 | Elesta S.P.A | GEX | Class II | 2026-08-19 |
| K262070 | Diode Laser Therapy Systems (DL612A) | Hebei Zollvan Medical Technology Co., Ltd. | GEX | Class II | 2026-08-19 |
| K261641 | Lower Limb AI (LLAI) | AI Planning Logic, Inc. | QIH | Class II | 2026-08-18 |
| K254250 | MagicScan-1.5, GreenMR Serenity 1.5T | Xingaoyi Medical Equipment Co.,Ltd | LNH | Class II | 2026-08-17 |
| K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions | KLS-Martin L.P. | JEY | Class II | 2026-08-17 |
| K261500 | KBA3D (v2.4.0) | S.M.A.I.O | LLZ | Class II | 2026-08-17 |
| K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03) | Jiangsu Enjosim Medical Technology Co., Ltd. | FMF | Class II | 2026-08-14 |
| K261890 | 52Fr ViSiGi LUX; 52Fr ViSiGi 3D® | Boehringer Laboratories, LLC | KNT | Class II | 2026-08-14 |
| K253790 | High Intensity Focused Electromagnetic Stimulation Device (FE60) | Beijing Winkonlaser Technology Limited | NGX | Class II | 2026-08-13 |
| K253795 | MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution | Menicon Co, Ltd. | LPN | Class II | 2026-08-13 |
| K261499 | TrachFlush | Aw Technologies Aps | BSK | Class II | 2026-08-13 |
| K261626 | UltraPrint Flexible Denture UV | Guangzhou Heygears IMC., Inc. | EBI | Class II | 2026-08-13 |
| K251641 | GF-310R Multigas Unit (GF-310R) | Nihon Kohden Corporation | CCK | Class II | 2026-08-12 |
| K253846 | Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pulse Probe (NPA-DJ01); Probe connection line (NPA-LX-02) | Hangzhou Ruidi Biotechnology , Ltd. | OAB | Class II | 2026-08-12 |
| K253985 | INNOVANCE® D-Dimer 2.0 (SMN 10873803) | Siemens Healthcare Diagnostic Products GmbH | DAP | Class II | 2026-08-11 |
| K261841 | Q Switched Nd:YAG Laser machine (QLQW-01) | Beijing Nubway S&T Co., Ltd. | GEX | Class II | 2026-08-11 |
| K260094 | Mobility Scooter (W3465, W3902 (S50 Carbon)) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | INI | Class II | 2026-08-10 |
| K251544 | Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) | Lakong Medical Devices Co., Ltd. | EIA | Class I | 2026-08-07 |
| K253702 | Intuitive Endoluminal Gastrointestinal System (IG1000) | Intuitive Surgical, Inc. | FDS | Class II | 2026-08-07 |
| K261905 | BUM Oil | Bumlicious, LLC (DBA Bumlicious) | NUC | Class II | 2026-08-07 |
| K261937 | PacTemp Automix NE | The Belport Company Inc., DBA Gingi-Pak | EMA | Class II | 2026-08-07 |
| K261571 | Manual Wheelchair (H008, PCK7) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | IOR | Class I | 2026-08-06 |
| K261576 | Icona Hip Stem | Corin, Ltd. | MEH | Class II | 2026-08-10 |
| K261602 | Eye Recovery Pro (PH-e03) | Shenzhen Goodwind Technology Development Co., Ltd. | OHS | Class II | 2026-08-10 |
| K261705 | Hair Removal Device (R3C16-G Pro, R3C16-V Pro) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | OHT | Class II | 2026-08-10 |
| K252853 | CAD - Lower GI (EC07-01) | Xiamen Inno Medical Technology Co., Ltd. | QNP | Class II | 2026-08-05 |
| K261456 | Ruthinium Disc | Dental Manufacturing S.p.A. | POW | Class II | 2026-08-05 |
| K261932 | Leksell® Vantage Stereotactic System | Elekta Solutions AB | HAW | Class II | 2026-08-05 |
| K262056 | Rusch Latex Gold Foley Catheter | Teleflex Medical Sdn. Bhd. | EZL | Class II | 2026-08-05 |
| K253760 | OMNI Ultra Surgical System (1-110) | Sight Sciences, Inc. | MRH | Class II | 2026-08-04 |
| K261915 | Navigator Flex Ureteral Access Sheath Set | Boston Scientific Corporation | FED | Class II | 2026-08-04 |
| K253655 | Angled Screwdriver MED (M-SD090) | W&H Dentalwerk Bürmoos GmbH | DZI | Class II | 2026-07-31 |
| K261824 | da Vinci Surgical System, Model IS5000 | Intuitive Surgical, Inc. | NAY | Class II | 2026-07-31 |
| K261854 | xvision Spine system | Augmedics, Ltd. | SBF | Class II | 2026-07-31 |
| K261912 | SnØreNegatØr | DnB Innovations, LLC | LRK | Class II | 2026-07-31 |
| K251959 | TnR Cranial Implant | T&R BIOFAB CO., Ltd. | GXP | Class II | 2026-07-30 |
| K261829 | Profoject Dual-Safety Pen Needles | CMT Health PTE., Ltd. | FMI | Class II | 2026-07-29 |
| K250419 | Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow) | Plus EV Holdings, Inc. D/B/A Intimate Rose | OSD | Class II | 2026-07-27 |
| K252370 | GEN 4 JOY Wheelchair | Free Wheelchair Mission | IOR | Class I | 2026-07-24 |
| K253703 | RemunityPRO+ Pump for Remodulin® (treprostinil) Injection | Deka R&D Corp | FRN | Class II | 2026-07-24 |
| K261781 | Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60 | Thermo Fisher Scientific (Oxoid Ltd.) | JTN | Class II | 2026-07-24 |
| K253932 | FACEGYM Pro Device (HD-109) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | NFO | Class II | 2026-07-23 |
| K261853 | Gepotidacin GEP 10 µg | Liofilchem, Inc. | JTN | Class II | 2026-07-23 |
| K254296 | Ossiclear (Ossiclear System) | Sounduct | LXB | Class II | 2026-07-22 |
| K253814 | Raney Clips Kit | Beijing Honghugaoxiang Science and Technology Development CO | HBO | Class II | 2026-07-21 |
| K262014 | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves | O&M Halyard, Inc. | LZA | Class I | 2026-07-21 |
| K254285 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Violet Blue | Hartalega NGC Sdn. Bhd. | LZA | Class I | 2026-07-20 |
| K251952 | Virasight | Virasoft Corporation | PSY | Class II | 2026-07-17 |
| K253694 | Natural Cycles | Natural Cycles Nordic AB | PYT | Class II | 2026-07-17 |
| K260021 | cobas® BV/CV | Roche Molecular Systems, Inc. | PQA | Class II | 2026-07-16 |
| K260050 | WRAP System | Huneo, LLC | MNR | Class II | 2026-07-15 |
| K253662 | LIXI (LXOSFM1) | Luwi, LLC | MSC | Class II | 2026-07-14 |
| K254295 | Sofia Lyme FIA; Sofia 2 Campylobacter FIA | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | LSR | Class II | 2026-07-10 |
| K261962 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic MiniMed | QJI | Class II | 2026-07-09 |
| K261396 | Electric Wheelchair | Ningbo Resshidi Medical Devices Co., Ltd. | ITI | Class II | 2026-07-08 |
| K261413 | EXTRON 3;EXTRON 6 | DRTECH Corporation | OWB | Class II | 2026-08-19 |
| K262537 | Versalock Sterile Plating System | GM Dos Reis Industria e Comercio Ltda. | HRS | Class II | 2026-08-19 |
| K262622 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | LNH | Class II | 2026-08-19 |
| K260266 | Tympendi (810) | Grace Medical, Inc. | KHJ | Class II | 2026-08-18 |
| K260794 | NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR | Kossan International Sdn Bhd | LZA | Class I | 2026-08-18 |
| K260984 | HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) | Axora Medical, Inc. | HIH | Class II | 2026-08-18 |
| K262135 | Lancing device | Tianjin Huahong Technology Co., Ltd. | QRL | Class II | 2026-08-18 |
| K262479 | TearCare System | Sight Sciences, Inc. | ORZ | Class II | 2026-08-18 |
| K262489 | BluEX Cervical Expandable Cage System | L&K BIOMED Co., Ltd. | ODP | Class II | 2026-08-18 |
| K262729 | TeKBrace Solo Soft Tissue Reinforcement Device | Theramicro | QUW | Class II | 2026-08-18 |
| K260224 | MySOZO Software version 6.1.0.1 (SW version 6.1.0.1) | ImpediMed Limited | DSB | Class II | 2026-08-17 |
| K260563 | CN-Suite | FIND Surgical Sciences Inc. D/B/A FIND Neuro | OLX | Class II | 2026-08-16 |
| K260171 | Portable Oxygen Concentrator (PO1 5B, PO1 6B) | BMC Medical Co., Ltd. | CAW | Class II | 2026-08-14 |
| K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal | Empatica S.r.l. | GYD | Class II | 2026-08-14 |
| K260438 | Vital Signs Monitor (CLEO2) | Infinium Medical, Inc. | MWI | Class II | 2026-08-14 |
| K260559 | NHanceIT | IMDS Operation B.V. | DQY | Class II | 2026-08-14 |
| K260898 | Transpara (2.1.0) | Screenpoint Medical B.V. | QDQ | Class II | 2026-08-14 |
| K261228 | QuickVision Ultimate rTMS | Brain Ultimate, Inc. | OBP | Class II | 2026-08-14 |
| K262419 | MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MF | Cerenovus, Inc. | HCG | Class II | 2026-08-14 |
| K262452 | AutoContour (RADAC V6) | Radformation, Inc. | QKB | Class II | 2026-08-14 |
| K262552 | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) | Scivita Medical Technology Co., Ltd. | FGB | Class II | 2026-08-14 |
| K262571 | EnCor EnCompass Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | KNW | Class II | 2026-08-14 |
| K262639 | BAGUERA® C Cervical Disc Surgical Instruments | Spineart SA | QLQ | Class II | 2026-08-14 |
| K260277 | MIKRON TRAUMA BONE PLATE& SCREW SYSTEM | Mikron Makina San. ve Tic. Ltd. Sti. | HRS | Class II | 2026-08-13 |
| K260413 | Levo Gen 2 Tinnitus Therapy System | Levo Medical Corporation | KLW | Class II | 2026-08-13 |
| K260907 | BIS Advance pEEG Module | Covidien LP | OLW | Class II | 2026-08-13 |
| K261139 | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) | Freyja Healthcare, LLC | GCJ | Class II | 2026-08-13 |
| K260944 | ManaCold Compression System | Manamed, LLC | IRP | Class II | 2026-08-12 |
| K262344 | Large Compression Screws | TriMed, Inc. | HWC | Class II | 2026-08-12 |
| K262406 | EluPro Antibiotic-Eluting BioEnvelope | Boston Scientific | FTM | Class II | 2026-08-12 |
| K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) | Hologic, Inc. | KNW | Class II | 2026-08-12 |
| K261115 | VR® Personal Protective Level 4 Gown (VR Gowns) | PolyConversions, Inc. | QPC | Class II | 2026-08-11 |
| K261398 | Dexter L6 System | Distalmotion SA | SDD | Class II | 2026-08-11 |
| K262472 | Stelo Glucose Biosensor System | Dexcom, Inc. | SBH | Class II | 2026-08-11 |
| K260165 | Unimpregnated Central Venous Catheter | Spectrum Vascular | FOZ | Class II | 2026-08-10 |
| K260176 | Mobility Scooter (W3483, W3483A) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | INI | Class II | 2026-08-10 |
| K262427 | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII) | Hh Global Technology, Inc. | FMI | Class II | 2026-08-10 |
| K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T) | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | FMI | Class II | 2026-08-07 |
| K261362 | Xpert Hemorrhagic Fever | Cepheid | QVR | Class II | 2026-08-07 |
| K260737 | Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18). | Convatec | EZD | Class II | 2026-08-05 |
| K260845 | Huahong Sharps Container (HHR-I, HHR-II) | Tianjin Huahong Technology Co., Ltd. | MMK | Class II | 2026-08-05 |
| K260919 | Transurethral Catheter Safety Valve (TUCSV) (80050) | Class Medical , Ltd. | KNY | Class II | 2026-08-05 |
| K261380 | Concentriq AP-Dx | Proscia, Inc. | QKQ | Class II | 2026-08-05 |
| K260381 | Eve | Wandercraft SAS | PHL | Class II | 2026-08-03 |
| K261183 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | Olympus Medical Systems Corporation | ODG | Class II | 2026-07-31 |
| K261187 | Hearing Aid Feature | Samsung Electronics Co., Ltd. | SCR | Class II | 2026-07-31 |
| K260566 | SMARTVERTIGO Vestibular Assessment System | VertigoDx, Inc. | GWN | Class II | 2026-07-30 |
| K260567 | EW10-EC02 Endoscopy Support Program | Fujifilm Corporation | QNP | Class II | 2026-08-07 |
| K260572 | Marrow Marxman | Medimetrix, LLC | KNW | Class II | 2026-08-04 |
| K262253 | Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) | Orthalign, Inc. | ONN | Class II | 2026-07-31 |
| K262681 | NanoCeram Resin | 3BFAB TEKNOLOJI A.S. | EBI | Class II | 2026-07-31 |
| K260620 | SeptAlign (SPLN001) | Spirair, Inc. | NHB | Class II | 2026-07-30 |
| K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) | Salter Labs | CCL | Class II | 2026-07-30 |
| K261410 | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) | Suite 201, National Innovation Centre | OLO | Class II | 2026-07-30 |
| K262239 | Obsidian® Press Over Zirconia | Prismatik Dentalcraft, Inc. | EIH | Class II | 2026-07-30 |
| K261058 | CraniUS Plate | CraniUS, LLC | GWO | Class II | 2026-07-29 |
| K261205 | SPINEART Navigation Instrument System | Spineart SA | OLO | Class II | 2026-07-29 |
| K262200 | Stone Clear (BWSC-LP9-02) | Sonomotion, Inc. | QNA | Class II | 2026-07-29 |
| K260326 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | Datex-Ohmeda, Inc. | FMZ | Class II | 2026-07-28 |
| K260529 | Air Compression Massager (HY-1165) | Xiamen High Top Electronic Technology Co., Ltd. | IRP | Class II | 2026-07-27 |
| K260382 | MONARCH Platform (MON-000008) | Auris Health, Inc. | EOQ | Class II | 2026-07-25 |
| K260259 | DiscreetDuo Flow Wearable Breast Pump (Model S3) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2026-07-24 |
| K260948 | Air Compression Massager (EP30B001 I) | Wavepulse (Xiamen) Healthcare Technology Co., Ltd. | IRP | Class II | 2026-07-24 |
| K261024 | TMINI Miniature Robotic System | THINK Surgical, Inc. | OLO | Class II | 2026-07-24 |
| K261027 | NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut | Hycor Biomedical | DHB | Class II | 2026-07-24 |
| K261274 | EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes | Cook Ireland, Ltd. | KTI | Class II | 2026-07-24 |
| K261312 | Temporary Keratoprosthesis (QuickSet TKP) | Eyekon Medical, Inc. | MLP | Class II | 2026-07-24 |
| K262121 | Ion-L Navigated Instruments | SurGenTec, LLC | OLO | Class II | 2026-07-24 |
| K262116 | TRUE METRIX Self Monitoring Blood Glucose System | Trividia Health, Inc. | NBW | Class II | 2026-07-23 |
| K260964 | NanoZoomer S540MD Slide Scanner System | Hamamatsu Photonics K.K. | PSY | Class II | 2026-07-22 |
| K261113 | Op.n Spine Navigation and Robotic Guidance | Ecential Robotics | OLO | Class II | 2026-07-22 |
| K260591 | NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut | Hycor Biomedical | DHB | Class II | 2026-07-21 |
| K261728 | One-Fil LC | Mediclus Co., Ltd. | EJK | Class II | 2026-07-21 |
| K261011 | Sleep Apnea Feature (v2.0) | Samsung Electronics Co., Ltd. | QZW | Class II | 2026-07-20 |
| K261046 | Dental Zirconia Blank & Coloring Liquid | Hunan Qinghao Puzhong Technology Co., Ltd. | EIH | Class II | 2026-07-17 |
| K261475 | BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit | Biofire Defense, LLC | PMN | Class II | 2026-07-17 |
| K261675 | CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) | Shenzhen Chuanghong Zhilian Technology Co., Ltd. | OAP | Class II | 2026-07-17 |
| K261706 | Endomat Select (UP220) | KARL STORZ SE & CO. KG | HIG | Class II | 2026-07-16 |
| K260739 | Profoject Pen Needles (Model A; Model B) | CMT Health PTE., Ltd. | FMI | Class II | 2026-07-15 |
| K260578 | Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US) | Ambu A/S | GXY | Class II | 2026-07-14 |
| K261232 | IERO Mobility Scooter (IERO-01) | Jochu Technology Co., Ltd. | INI | Class II | 2026-07-14 |
| K261633 | VisuBreath | Affirm Medical Technologies II, LLC | CCK | Class II | 2026-07-14 |
| K260208 | Ultra-Fine SAFETY Insulin Syringe | embecta Medical II, LLC | FMF | Class II | 2026-07-13 |
| K261199 | Wearable Breast Pump (Model S32A) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2026-07-13 |
| K260880 | SedLine Sedation Monitor | Masimo Corporation | OLW | Class II | 2026-07-10 |
| K260902 | Cochlear Osia® 3(I) Sound Processor;Cochlear Osia® 3 Sound Processor;Cochlear Osia® 3 Charger;Cochlear Osia® 3 Aqua+;Cochlear Osia® Fitting Software 3;Cochlear Osia® Smart App;Cochlear Osia® System | Cochlear Americas | PFO | Class II | 2026-07-10 |
| K261041 | ClearSafe Closed System | MedSource Labs, LLC | FOZ | Class II | 2026-07-10 |
| K261149 | Electric Wheelchair (DY611A-2, DY612A-1) | Zhejiang Lumbre Electric Appliance Co., Ltd. | ITI | Class II | 2026-07-10 |
| K261212 | Flowflex Plus RSV + Flu A/B + COVID Rapid Test | ACON Laboratories, Inc. | SCA | Class II | 2026-07-10 |
| K260539 | MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter | MedSource Labs, LLC | FOZ | Class II | 2026-07-09 |
| K261177 | PINKSLIP Water-Based Personal Lubricant and Moisturizer | PINKSLIP, LLC | NUC | Class II | 2026-07-09 |
| K260160 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | bioMerieux, Inc. | SAN | Class II | 2026-07-08 |
| K260917 | cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems | Roche Molecular Systems, Inc. | QEP | Class II | 2026-07-08 |
| K261163 | Mobility Scooter (R200) | Yongkang Ruihe Metal Product Co., Ltd. | INI | Class II | 2026-07-07 |
| K261166 | DIA-CEM | DiaDent Group International | EMA | Class II | 2026-07-09 |
| K261471 | Zeta TMS Navigation System | Zeta Surgical, Inc. | QFF | Class II | 2026-07-09 |
| K262300 | Denture Base Resin V2 | Formlabs Ohio, Inc. | EBI | Class II | 2026-07-08 |
| K261164 | Electric wheelchair (XW-LY007 ) | Yongkang Ruihe Metal Product Co., Ltd. | ITI | Class II | 2026-07-07 |
| K261812 | HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens | HOYA Lamphun , Ltd. | MVN | Class II | 2026-07-07 |
| K261909 | Plum Vagiceuticals Vaginal Moisturizing Suppositories | PCCA, Inc. | NUC | Class II | 2026-07-06 |
| K253704 | iPredict-DR | iHealthscreen, Inc. | PIB | Class II | 2026-07-02 |
| K260527 | FACE4D Aligner | Avinent Implant System S.L.U. | NXC | Class II | 2026-07-02 |
| K260755 | OptraSCAN System | Optrascan, Inc. | NOT | Class II | 2026-07-02 |
| K261129 | OrthoFit | Spident Co., Ltd. | DYH | Class II | 2026-07-02 |
| K261847 | iTero Lumina Pro | Align Technology , Ltd. | NTK | Class II | 2026-07-02 |
| K261867 | Xpert Carba-R | Cepheid® | POC | Class II | 2026-07-02 |
| K261897 | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology | O&M Halyard, Inc. | FRG | Class II | 2026-07-02 |
| K261147 | Neodent Implant System - NeoConvert Fit | JJGC Indústria e Comércio de Materiais Dentários S.A. | NHA | Class II | 2026-07-01 |
| K261474 | DENTCA Tru Flexible | Dentca, Inc. | EBI | Class II | 2026-07-01 |
| K261485 | Tetric plus Fill;Tetric plus Flow | Ivoclar Vivadent, Inc. | EBF | Class II | 2026-07-01 |
| K261852 | OTS Hip | Ortoma AB | OLO | Class II | 2026-07-01 |
| K262228 | Transcend Bulk Fill Flowable Composite | Ultradent Products, Inc. | EBF | Class II | 2026-07-01 |
| K253767 | UB ERP System | Universal Brain | OLT | Class II | 2026-06-30 |
| K261101 | Ceribell Monitor | Ceribell, Inc. | OMC | Class II | 2026-06-30 |
| K262195 | Dandy Ceramic Stain and Glaze | Zima International Inc., dba Dandy | EIH | Class II | 2026-06-30 |
| K260918 | Zolid Lunaris | Amann Girrbach AG | EIH | Class II | 2026-06-29 |
| K261415 | Injectable Root Canal Sealer (KP-Root SP) | Guilin Kevin Peter Technology Co., Ltd. | KIF | Class II | 2026-06-29 |
| K261461 | Omnipod 6 algorithm | Insulet Corporation | QJI | Class II | 2026-06-29 |
| K261122 | MIST IC | Imagine Milling Technologies, LLC | NHA | Class II | 2026-06-27 |
| K250070 | Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) | Shenzhen Changkun Technology Co., Ltd. | HGX | Class II | 2026-06-26 |
| K253921 | VERTICALE® Navigation Instruments | Silony Medical GmbH | OLO | Class II | 2026-06-26 |
| K260412 | TENS 7000 Rechargeable 4 Channel (TENS 7000H) | Shenzhen Dongdixin Technology Co., Ltd. | NUH | Class II | 2026-06-26 |
| K261039 | i-STAT Crea cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | CGL | Class II | 2026-06-26 |
| K261253 | Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5) | Ziree Co., Ltd. | OAP | Class II | 2026-06-26 |
| K261442 | Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array | Cadwell Industries, Inc. | GXY | Class II | 2026-06-26 |
| K252584 | Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C) | Weyo Surgical Technology , Ltd. | HIF | Class II | 2026-06-25 |
| K260480 | VELYS Robotic-Assisted Solution | Depuy Ireland UC | OLO | Class II | 2026-06-25 |
| K260992 | iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) | Neuralytix | PDQ | Class II | 2026-06-25 |
| K261025 | Wearable breast pump (QY-101, QY-102, QY-108) | Shenzhen Qinyi Electronic Technology Co., Ltd. | HGX | Class II | 2026-06-25 |
| K252117 | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution | Sw Technologies, Inc. | LZA | Class I | 2026-06-24 |
| K260937 | Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) | Shanghai Waylong Intelligent Technology Co.,Ltd | ITI | Class II | 2026-06-24 |
| K260998 | Ceribell Neurology Review Software | Ceribell, Inc. | OMB | Class II | 2026-06-24 |
| K261055 | AMSCO 700 Steam Sterilizer | STERIS Corporation | FLE | Class II | 2026-06-24 |
| K261772 | Target Xtra Detachable Coil | Stryker Neurovscular | HCG | Class II | 2026-06-24 |
| K261075 | Manual Wheelchair (MS01);Manual Wheelchair (MA01) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | IOR | Class I | 2026-06-22 |
| K261076 | Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | IOR | Class I | 2026-06-22 |
| K251559 | InstaTRU Instant Biological Indicator for Steam (IBI-05) | True Indicating, LLC | QVB | Class II | 2026-06-18 |
| K252066 | inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009); inspired Auto-feed Humidification Chamber (VHC10); inspired Auto-feed Humidification Chamber (VHC20) | Vincent Healthcare Products Limited | BZE | Class II | 2026-06-18 |
| K253812 | Power Wheelchair (W5915B, W5915C, W5915D) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | ITI | Class II | 2026-06-18 |
| K254254 | Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) | Shenzhen Root Innovation Technology Co., Ltd. | HGX | Class II | 2026-06-18 |
| K260280 | NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg | Hycor Biomedical | DHB | Class II | 2026-06-18 |
| K261099 | Blood Volume Analyzer (200) | Daxor Corporation | JWO | Class II | 2026-06-18 |
| K252399 | Portable Oxygen Concentrator | Honsun (Nantong) Co., Ltd. | CAW | Class II | 2026-06-17 |
| K260867 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) | Hartalega NGC Sdn. Bhd. | LZA | Class I | 2026-06-17 |
| K260916 | FLEXI-PORT Power Injectable Implantable Port | Portal Access, Inc. | LJT | Class II | 2026-06-17 |
| K261544 | Hydro Irrigation System | Stryker Instruments | EOB | Class II | 2026-06-17 |
| K261672 | twiist Automated Insulin Delivery (AID) System | Deka Research and Development | QFG | Class II | 2026-06-17 |
| K253001 | KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) | Hunan Ruijiong Biotech Co., Ltd. | NHJ | Class II | 2026-06-16 |
| K260899 | Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) | Zdeer Technology (Henan) Co., Ltd. | OAP | Class II | 2026-06-16 |
| K260333 | LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit | Diasorin Molecular, LLC | PGX | Class II | 2026-06-15 |
| K260335 | Electric Wheelchair (S500-6) | Zhongshan Sulenz Intelligent Technology Co., Ltd. | ITI | Class II | 2026-06-15 |
| K260452 | Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158) | Zdeer Technology (Henan) Co., Ltd. | LXB | Class II | 2026-06-15 |
| K252323 | cobas pulse blood glucose monitoring system | Roche Diagnostics | PZI | Class II | 2026-06-12 |
| K252932 | Fast PCR Mini Respiratory Panel | Autonomous Medical Devices Incorporated | QOF | Class II | 2026-06-12 |
| K252963 | BTL-899TT | BTL Industries, Inc. | IMJ | Class II | 2026-06-12 |
| K252987 | ADRx Admixture Device | Epic Medical Pte. , Ltd. | LHI | Class II | 2026-06-12 |
| K260346 | Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) | Polybell (Guangzhou) Limited | HGX | Class II | 2026-06-12 |
| K260935 | Stelo Glucose Biosensor System | Dexcom, Inc. | SBH | Class II | 2026-06-12 |
| K261175 | WHILL (WHILL Model C2) | Whill, Inc. | ITI | Class II | 2026-06-12 |
| K251326 | Respiration Rate algorithm | Edwards Lifesciences, LLC | BZQ | Class II | 2026-06-11 |
| K260849 | ICON 35; ICON 45; ICON 60; ICON 30FAF | Rehasense USA, Inc. | IOR | Class I | 2026-06-11 |
| K261256 | Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) | Shenzhen Magnet Technology Co., Ltd. | LXB | Class II | 2026-06-11 |
| K261292 | PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) | PR Personal Care Laboratories | NUC | Class II | 2026-06-11 |
| K260855 | Profoject Safety Pen Needles | CMT Health PTE., Ltd. | FMI | Class II | 2026-06-10 |
| K261174 | RxSight® Insertion Device | Rxsight, Inc. | MSS | Class I | 2026-06-10 |
| K252914 | Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) | Hathor Professional Skincare , Ltd. | NUC | Class II | 2026-06-09 |
| K260864 | Mother's Nature W1 Warming Wearable Breast Pump | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2026-06-09 |
| K261402 | Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System | Dexcom, Inc. | QBJ | Class II | 2026-06-08 |
| K251684 | Alma TED+ System | Alma Lasers, Inc. | OAP | Class II | 2026-06-05 |
| K260056 | Power Wheelchair (N5515A, N5516, N5517A, N5519) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | ITI | Class II | 2026-06-05 |
| K260301 | Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | LHI | Class II | 2026-06-05 |
| K260956 | Spectra Platinum Mini | Uzinmedicare Co., Ltd. | HGX | Class II | 2026-06-04 |
| K260373 | Electric Wheelchair (DF506) | Jiangsu Yveelt Medical Equipment Co., Ltd. | ITI | Class II | 2026-06-03 |
| K260703 | Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl | S&S Glove Corporation | LZA | Class I | 2026-06-03 |
| K260709 | ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754) | Longeviti Neuro Solutions | GXN | Class II | 2026-06-25 |
| K260538 | Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) | Shenzhen Root Innovation Technology Co., Ltd. | HGX | Class II | 2026-06-17 |
| K260514 | Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle | CMT Health PTE., Ltd. | FMF | Class II | 2026-06-12 |
| K260614 | Tinnitus Therapy | Sivantos GmbH | KLW | Class II | 2026-06-10 |
| K260754 | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test | Assure Tech., LLC | QYT | Class II | 2026-06-05 |
| K260770 | LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX | DiaSorin, Inc. | LOM | Class II | 2026-06-04 |
| K260726 | Straumann® ProClean Cassette (041.800 ; 041.801) | Institut Straumann AG | KCT | Class II | 2026-06-03 |
| K260806 | Nitrile Disposable Examination Gloves | Vista Industries,, LLC | LZA | Class I | 2026-06-03 |
| K261530 | iiSure Infusion Set | Deka Research and Development | FPA | Class II | 2026-06-03 |
| K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP) | Mohammadali Nezakati | IPF | Class II | 2026-06-02 |
| K252854 | SteriTite Container System with MediTray Products | Case Medical, Inc. | KCT | Class II | 2026-06-03 |
| K252844 | Tyto Insights for Wheeze Detection (with PCCP) | Tyto Care , Ltd. | PHZ | Class II | 2026-06-02 |
| K252899 | Female Culture Device; Male Culture Device; Transfer Device; Access Device | Zhejiang Kindly Medical Device Co., Ltd. | JKA | Class II | 2026-06-02 |
| K260270 | FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) | FindAir Sp. z o.o. | CAF | Class II | 2026-06-02 |
| K260642 | Manual Wheelchair (LW01108) | Anhui Longway Medical Technology Co., Ltd. | IOR | Class I | 2026-06-02 |
| K252396 | Cryo Sport 2.0 (AVA 501) | Avanutri Equipamentos DE Saúde | IRP | Class II | 2026-05-29 |
| K252802 | Peak Flow Meter (PF-10(BR-PEF231)) | Shenzhen Bi-Rich Medical Devices Co., Ltd. | BZH | Class II | 2026-05-29 |
| K252965 | Oxygen Concentrator (OX-5A, OX-5C) | Oxytek Medical Technology Co., Ltd. | CAW | Class II | 2026-05-29 |
| K254300 | eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009) | Anker Innovations Limited | HGX | Class II | 2026-05-29 |
| K260507 | Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus | INTEROJO, Inc. | LPL | Class II | 2026-05-29 |
| K252823 | Dukal Crepe Paper Sterilization Wrap | Dukal, LLC | FRG | Class II | 2026-05-28 |
| K260213 | BD BACTEC FXI Culture System | BD Diagnostic Systems | MDB | Class I | 2026-05-28 |
| K260295 | Helio Kids; Apex P | Motion Composites | IOR | Class I | 2026-05-28 |
| K253971 | Visby Medical Flu and COVID-19 Test | Visby Medical, Inc. | SIA | Class II | 2026-05-27 |
| K253988 | LiteSet Trays | Nobel Biocare AB | KCT | Class II | 2026-09-08 |
| K253989 | HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST) | Maxigen Biotech, Inc. | NUC | Class II | 2026-09-03 |
| K254000 | Happy Health Blood Pressure Monitor | Happy Health, Inc. | DXN | Class II | 2026-09-03 |
| K254035 | Mayumi Thrombectomy System | MicroVention, Inc., d/b/a Terumo Neuro | QEZ | Class II | 2026-09-03 |
| K254090 | I-View® | Hologic, Inc. | MUE | Class II | 2026-09-02 |
| K254198 | Trexo Theo | Trexo Robotics, Inc. | PHL | Class II | 2026-09-02 |
| K254071 | p17 XR Microcatheter | Wallaby Medical | QJP | Class II | 2026-08-18 |
| K254069 | Hemoclip (511 series, 543 series) | Hangzhou AGS MedTech Co., Ltd. | PKL | Class II | 2026-08-10 |
| K254042 | WatchPAT SW | Itamar Medical , Ltd. | MNR | Class II | 2026-07-31 |
| K254038 | Motivista (CT-155) | Click Therapeutics, Inc. | SAP | Class II | 2026-07-30 |
| K254011 | Flow Water-Based Personal Lubricant | LBDO Group, Inc. | NUC | Class II | 2026-06-22 |
| K254026 | 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U) | Flexicare Medical Limited. | EOQ | Class II | 2026-09-02 |
| K254217 | Aerloom | Evolym, LLC | JOW | Class II | 2026-08-31 |
| K254027 | Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90) | Sonoscape Medical Corp. | IYN | Class II | 2026-08-24 |
| K254213 | Pascall Sensor Unit (PSU1) | Pascall Systems, Inc. | OLT | Class II | 2026-08-19 |
| K254201 | Any-Cem | Mediclus Co., Ltd. | EMA | Class II | 2026-08-13 |
| K254036 | Novii+ Wireless Patch System | Datex Ohmeda, Inc. | HGM | Class II | 2026-08-10 |
| K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw | Nobel Biocare AB | NHA | Class II | 2026-08-06 |
| K254194 | QIAstat-Dx BCID GPF Plus AMR Panel | QIAGEN GmbH | PAM | Class II | 2026-08-06 |
| K254044 | Hearing assist | Meta Platform Technologies, LLC | SCR | Class II | 2026-07-13 |
| K254037 | LungFlow Airway Catheter | Free Flow Medical, Inc. | EOQ | Class II | 2026-07-10 |
| K254104 | ResScan Essentials | Resmed Corp | BZD | Class II | 2026-05-27 |
| K254108 | Jabra Enhance Select Self-fit (Jabra Enhance Select 550) | GN Hearing A/S | QUH | Class II | 2026-06-25 |
| K254121 | Colli-PeeDx Urine Collection Kit | DNA Genotek, Inc. | SIH | Class II | 2026-06-10 |
| K254102 | Glucommander | Glytec, LLC | NDC | Class II | 2026-05-27 |
| K260142 | StimelMD (SSMD) system | Motion Informatics ltd. | IPF | Class II | 2026-05-27 |
| K261098 | TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) | Senzime AB | KOI | Class II | 2026-05-22 |
| K251920 | Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask | Dcstar, Inc. | BZD | Class II | 2026-05-21 |
| K252746 | Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) | Drägerwerk AG Co. Kgaa | BSZ | Class II | 2026-05-21 |
| K254141 | Manual Wheelchair (DY01903(2)) | Guangdong Dayang Medical Technology Co., Ltd. | IOR | Class I | 2026-05-21 |
| K254244 | Wearable Breast Pump (Model S39) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | 2026-05-21 |
| K260068 | pjur NATURE Touch, 100 ml | Pjur Group Luxembourg S.A. | NUC | Class II | 2026-05-21 |
| K261359 | Stelo Glucose Biosensor System | Dexcom, Inc. | SAF | Class II | 2026-05-21 |
| K260577 | FilmArray TF Control Panel M527 | Maine Molecular Quality Controls, Inc. | PMN | Class II | 2026-05-19 |
| K261299 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | LPL | Class II | 2026-05-19 |
| K252624 | KARL STORZ Laryngoscopes and Accessories | KARL STORZ Endoscopy-America, Inc. | EQN | Class II | 2026-05-15 |
| K252643 | Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled | Teleflex Medical Sdn. Bhd. | CAH | Class II | 2026-05-15 |
| K254050 | Manual Tissue Removal Device | Suzhou AcuVu Medical Technology Co., Ltd. | HIH | Class II | 2026-05-15 |
| K260059 | NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis) | Hycor Biomedical | DHB | Class II | 2026-05-15 |
| K261264 | Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite Pack (SE5423); 23 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5423B); 25 ga. Posterior Elite Pack (SE5425); 25 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5425B); 27 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5427B); 23 ga. Bi-Blade+ Vitreous Cutter Posterior Stellaris Elite Pack (SE5423BB+); 25 ga. Bi-Blade+ | Bausch and Lomb | HQC | Class II | 2026-05-15 |
| K254133 | ENTity USB Videoscope System | Optim, LLC | EOB | Class II | 2026-05-14 |
| K260565 | SmartClip Delivery Catheter (ADR-1715) | Elucent Medical | EOQ | Class II | 2026-05-14 |
| K254125 | Electric Breast Pump (HL-3058 II Pro) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | HGX | Class II | 2026-05-13 |
| K260051 | CorVision® (91-205-Z0014) | CorVent® Medical, Inc. | MOD | Class II | 2026-05-12 |
| K260235 | CellDx-Tissue | Datar Cancer Genetics Private Limited | PZM | Class II | 2026-05-12 |
| K260842 | HardyDisk AST Gepotidacin 10µg (GEP10) | Hardy Diagnostics | JTN | Class II | 2026-05-11 |
| K252622 | Male Latex Condom HA | Okamoto USA, Inc. | HIS | Class II | 2026-05-04 |
| K254115 | ArteraAI Breast | Artera, Inc. | SHW | Class II | 2026-05-04 |
| K252475 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | JGS | Class II | 2026-05-01 |
| K252488 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | CGA | Class II | 2026-05-01 |
| K254139 | BioCode® Respiratory Pathogen Panel (RPP) | Applied BioCode, Inc. | OCC | Class II | 2026-05-01 |
| K260910 | EndoTool IV Cloud 1.0 | Glooko, Inc. | NDC | Class II | 2026-05-01 |
| K251583 | Ambu® Virobac II® Exhalation Filter | Ambu A/S | CAH | Class II | 2026-04-30 |
| K252455 | FSYX Ocular Pressure Adjusting Pump | Balance Ophthalmics, Inc. | QQJ | Class II | 2026-04-30 |
| K252849 | AffloVest® Mobile Airway Clearance Therapy | Tactile Medical | BYI | Class II | 2026-04-30 |
| K260342 | AllTest Strep A Rapid Test | Hangzhou AllTest Biotech Co., Ltd. | GTY | Class I | 2026-04-30 |
| K260194 | Vacuum Pump (Model: AD-VPUM-500) | Sheng Sheng Yi (Beijing) Technology Company Limited | MQG | Class II | 2026-04-28 |
| K260248 | Ultra-Fast Warm | Kitazato Corporation | MQL | Class II | 2026-04-28 |
| K252409 | TearCare MGX System | Sight Sciences, Inc. | ORZ | Class II | 2026-04-27 |
| K252424 | Anti-HCV Next | Abbott Laboratories | MZO | Class II | 2026-04-28 |
| K252628 | CASSIE | Wesper, Inc. | MNR | Class II | 2026-04-27 |
| K252748 | Pelvic Floor Exerciser (PF01) | Hunan Accurate Bio-Medical Technology Co., Ltd. | HIR | Class II | 2026-04-27 |
| K252431 | Elecsys Calcitonin | Roche Diagnostics GmbH | JKR | Class II | 2026-04-24 |
| K260429 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | QJI | Class II | 2026-04-24 |
| K252341 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) | Olympus Medical Systems Corp. | EOQ | Class II | 2026-04-23 |
| K252407 | OxyGo Portable Oxygen Concentrator (1400-7000) | Mv Life, LLC | CAW | Class II | 2026-04-23 |
| K252436 | Tula Tympanostomy Tube Delivery Device | Tusker Medical, Inc. | ETD | Class II | 2026-04-23 |
| K260239 | Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862) | Jiangxi AOV Maternity & Baby Products Co., Ltd. | HGX | Class II | 2026-04-22 |
| K260447 | ETEST Gepotidacin (GEP) (0.016-256 µg/mL) | bioMérieux SA | JWY | Class II | 2026-04-21 |
| K252338 | MySleepDash | Somnetics International, Inc. (Dba Transcend Inc) | BZD | Class II | 2026-04-17 |
| K260696 | MTS Gepotidacin 0.016-256 µg/mL | Liofilchem s.r.l. | JWY | Class II | 2026-04-17 |
| K251478 | ClearTip TBNA Type | Finemedix Co., Ltd. | KTI | Class II | 2026-04-16 |
| K252728 | IDS-iSYS Total Testosterone | Immunodiagnostic Systems Limited | CDZ | Class I | 2026-04-15 |
| K260128 | BD Preset and BD A-Line Arterial Blood Collection Syringes | Becton, Dickinson and Company | JKA | Class II | 2026-04-15 |
| K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | bioMerieux, Inc. | LON | Class II | 2026-04-15 |
| K252663 | Inbentus Versatile | Iconic Solutions by Murcia, SL | CBK | Class II | 2026-04-14 |
| K252280 | Elecsys Anti-SARS-CoV-2 S | Roche Diagnostics | QVP | Class II | 2026-04-13 |
| K260095 | Heal-Check Rapid COVID-19 Antigen Self-Test | Healgen Scientific,, LLC | QYT | Class II | 2026-04-13 |
| K252207 | ABL90 FLEX PLUS System, safeCLINITUBES | Radiometer Medicals Aps | CHL | Class II | 2026-04-10 |
| K252378 | BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube | Becton, Dickinson and Company | JKA | Class II | 2026-04-10 |
| K252506 | BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder | Becton, Dickinson and Company | JKA | Class II | 2026-04-10 |
| K252228 | Seaman Pro/Seaman | Checkcells, Inc. | POV | Class II | 2026-04-09 |
| K260420 | LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) | MacroLux Medical Technology Co., Ltd. | EOQ | Class II | 2026-04-08 |
| K252979 | Voyager DSLT (430840610) | Belkin Vision, Ltd. | HQF | Class II | 2026-04-07 |
| K260046 | Elecsys Anti-HBc II | Roche Diagnostics | SEI | Class II | 2026-04-07 |
| K260048 | Elecsys Anti-HAV IgM | Roche Diagnostics | LOL | Class II | 2026-04-07 |
| K260049 | Elecsys Anti-HBc IgM | Roche Diagnostics | SEI | Class II | 2026-04-07 |
| K260718 | mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850) | MED-EL Elektromedizinische Geräte GmbH | ETB | Class II | 2026-04-03 |
| K260719 | mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50 | MED-EL Elektromedizinische Geräte GmbH | ETA | Class II | 2026-04-03 |
| K260720 | mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735); | MED-EL Elektromedizinische Geräte GmbH | ETB | Class II | 2026-04-03 |
| K260026 | Tina-quant Cardiac high sensitivity CRP III | Roche Diagnostics | NQD | Class II | 2026-04-02 |
| K260184 | Onclarity Self-Collection Kit | Becton, Dickinson and Company | SEP | Class II | 2026-04-02 |
| K253586 | RM Electrode (RMH 25-01) | Retmap, Inc. | HLZ | Class II | 2026-04-01 |
| K253606 | NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | PSY | Class II | 2026-07-15 |
| K253824 | Powder Free Nitrile Examination Gloves Non-Sterile Black | Kanglongda Vietnam Protection Technology Company Limited | LZA | Class I | 2026-06-18 |
| K253688 | MEDRAD® Imaging Bulk Package Transfer Spike | Bayer Medical Care, Inc. | PQH | Class II | 2026-06-12 |
| K253051 | i-STAT hs-TnI cartridge with the i-STAT Alinity System | Abbott Point of Care, Inc. | MMI | Class II | 2026-06-11 |
| K253063 | Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) | Vitaltec Corporation | BTO | Class II | 2026-09-11 |
| K253529 | Peerbridge COR MDx (Cor MDx) | Peerbridge Health, Inc. | MWJ | Class II | 2026-09-04 |
| K253065 | Aevumed SUPERCYNCH Button System | Aevumed, Inc. | MBI | Class II | 2026-09-02 |
| K253240 | PrecivityAD2 Test | C2N Diagnostics, LLC | SET | Class II | 2026-08-19 |
| K253431 | Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN) | Shokz Health Global Limited | LXB | Class II | 2026-08-19 |
| K253562 | medilogFD | Schiller AG | MWJ | Class II | 2026-08-14 |
| K253468 | Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A) | Nova Eye, Inc. | MPA | Class II | 2026-08-10 |
| K253528 | Atellica IM CA 19-9 II | Siemens Healthcare Diagnostics, Inc. | NIG | Class II | 2026-08-10 |
| K253453 | Metrix COVID Test; Metrix COVID Test Pro | Aptitude Medical Systems, Inc. | QWB | Class II | 2026-08-07 |
| K253505 | Zamenix P | Roen Surgical, Inc. | FGB | Class II | 2026-08-07 |
| K253554 | Aperio GT 450 DX; Aperio GT 180 DX | Leica Biosystems Imaging, Inc. | PSY | Class II | 2026-08-07 |
| K253561 | Aperio iQC DX Software | Leica Biosystems Imaging, Inc. | SIX | Class II | 2026-08-07 |
| K253469 | Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM) | Mozarc Medical Us, LLC | FIE | Class II | 2026-08-06 |
| K253206 | METICULY Patient-specific CMF solution | Meticuly Co., Ltd. | JEY | Class II | 2026-07-25 |
| K253044 | RXiBreeze PAP System (RXiBreeze 20C) | Resvent Medical Technology Co., Ltd. | BZD | Class II | 2026-07-23 |
| K253317 | Cytrans Elashield | GC America, Inc. | LYC | Class II | 2026-07-06 |
| K253527 | Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) | Covidien, LLC | GAG | Class II | 2026-07-01 |
| K253301 | BraiN20® (BraiN20) | Time IS Brain, S.L. | GWF | Class II | 2026-06-27 |
| K253390 | SOMNUM (SOMNUM) | Honeynaps Co., Ltd. | OLZ | Class II | 2026-06-27 |
| K253316 | PhAST instrument and PhAST Blood Culture Gram-negative Panel | Phast Corp. | SAN | Class II | 2026-06-26 |
| K253274 | BedDot (G1) | Intelligent Dots, LLC | BZQ | Class II | 2026-06-25 |
| K253330 | A5 Anesthesia System (A5); A7 Anesthesia System (A7) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | BSZ | Class II | 2026-06-25 |
| K253367 | EliA CTD 13 Screen | Phadia AB | LLL | Class II | 2026-06-25 |
| K253180 | Microlife Digital Peak Flow Meter, Model PF200B (PF200B) | Microlife Corporation | BZH | Class II | 2026-06-23 |
| K253148 | RX-1 Sleep | Vivaquant, Inc. Dba Rhythm Express | MNR | Class II | 2026-06-22 |
| K253176 | TearView | Beyond 700 Pty, Ltd. | HKI | Class II | 2026-06-22 |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | Sol-Millennium Medical, Inc. | FMF | Class II | 2026-06-18 |
| K253187 | SteriBest® Sterilization Tray System | Mastel Surgical | KCT | Class II | 2026-06-18 |
| K253333 | Assisted Reproduction Laser System (Model ILS-400M) | Hua Yue Medical Technology Co., Ltd. | MRX | Class II | 2026-06-17 |
| K253069 | Lipoprotein (a) Molarity Assay | Diazyme Laboratories, Inc. | DFC | Class II | 2026-06-16 |
| K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T | Fujifilm Corporation | EOQ | Class II | 2026-06-16 |
| K253231 | Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500) | Hubei Yjt Technology Co.,Ltd | OAP | Class II | 2026-06-16 |
| K253121 | Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle | Gimbo Medical Technology Shenzhen Co., Ltd. | MQE | Class II | 2026-06-15 |
| K253437 | Spiro-VISTA | Spiro Robotics | BTR | Class II | 2026-06-12 |
| K253919 | Cryo And Thermo Therapy System | Xiamen Weiyou Intelligent Technology Co., Ltd. | IRP | Class II | 2026-06-10 |
| K253257 | Virgo Mobility Scooter (Virgo-D,Virgo-F) | Jiangsu Intco Medical Products Co., Ltd. | INI | Class II | 2026-06-08 |
| K253600 | Scooter (YD-03) | Yurob Rehabilitation Medical Co., Ltd. | INI | Class II | 2026-06-03 |
| K253882 | CorDx Tyfast COVID-19 Ag Rapid Test Rx | CorDx, Inc. | QVF | Class II | 2026-06-01 |
| K253911 | Derma-2 | Neko Health AB | LHQ | Class I | 2026-05-20 |
| K253722 | LIAISON PLEX Gastrointestinal Flex Assay | Luminex Corporation | PCH | Class II | 2026-05-19 |
| K253642 | Jada System (Jada-2002) | Organon, LLC | OQY | Class II | 2026-05-15 |
| K253756 | cobas liat CT/NG nucleic acid test | Roche Molecular Systems, Inc. | QEP | Class II | 2026-05-15 |
| K253759 | cobas liat CT/NG/MG nucleic acid test | Roche Molecular Systems, Inc. | QEP | Class II | 2026-05-15 |
| K253647 | Evita (V800); Evita (V600) | Draegerwerk AG & CO Kgaa | CBK | Class II | 2026-05-07 |
| K253837 | SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module | Heidelberg Engineering GmbH | OBO | Class II | 2026-05-07 |
| K253976 | iLet ACE Pump | Beta Bionics, Inc. | QFG | Class II | 2026-04-30 |
| K253885 | PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES | GEO MEDICAL CO., LTD. | LPL | Class II | 2026-04-29 |
| K253914 | Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) | Shenzhen Root Innovation Technology Co., Ltd. | HGX | Class II | 2026-04-29 |
| K253658 | STA Satellite Max® | Diagnostica Stago, Inc. | JPA | Class II | 2026-04-27 |
| K253822 | GPA (hexafocon A) Rigid Gas Permeable Contact Lenses | Zhuhai Fitlens Medical Technology Co., Ltd. | HQD | Class II | 2026-03-27 |
| K253834 | VISUREF 600 | Carl Zeiss Vision GmbH | HJO | Class II | 2026-03-18 |
| K253743 | MiniMed Flex pump | Medtronic Minimed, Inc. | QFG | Class II | 2026-03-12 |
| K253536 | Evala Nerve Stimulator (EPNR002) | Epineuron Technologies, Inc. | ETN | Class II | 2026-02-27 |
| K253542 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | IPF | Class II | 2026-06-08 |
| K253162 | Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG) | Unimed Medical Supplies, Inc. | FLL | Class II | 2026-06-05 |
| K253020 | Strauss Surgical Resection Instruments | American Medical Endoscopy, Inc. | HIH | Class II | 2026-06-04 |
| K253553 | Orion | Resmed Corp | BZD | Class II | 2026-06-04 |
| K253119 | CoSense ETCO Monitor | Capnia, Inc. | CCJ | Class II | 2026-05-29 |
| K253212 | XR-Series (XR-10, XR-20) Automated Hematology Analyzers | Sysmex America, Inc. | GKZ | Class II | 2026-05-27 |
| K253352 | Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | LPL | Class II | 2026-05-21 |
| K253030 | Capnostream35 Portable Respiratory Monitor (PM35MN) | Covidien, LLC | CCK | Class II | 2026-05-01 |
| K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | BMC Medical Co., Ltd. | BZD | Class II | 2026-04-29 |
| K253580 | Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) | Tedan Surgical Innovations | PDQ | Class II | 2026-04-26 |
| K253573 | ASTar BC G- Kit | Q-Linea AB | SAN | Class II | 2026-04-15 |
| K252269 | FINDER Flu A&B/SARS-CoV-2 Test | Baebies, Inc. | QOF | Class II | 2026-03-30 |
| K260812 | Francisella tularensis Real-time PCR Assay | Centers for Disease Control and Prevention | SGA | Class II | 2026-03-30 |
| K260041 | MDx-Chex for BCP | Streck, LLC | PMN | Class II | 2026-03-27 |
| K260281 | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) | BIOMERIEUX | LON | Class II | 2026-03-26 |
| K252052 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) | Bausch and Lomb, Incorporated | HQC | Class II | 2026-03-25 |
| K253184 | Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) | Zhuhai Wesee Meditech Co., Ltd. | EOB | Class II | 2026-03-25 |
| K252169 | Access BNP II | Beckman Coulter, Inc. | NBC | Class II | 2026-03-24 |
| K260787 | FebriDx Bacterial/Non-bacterial Assay | Lumos Diagnostics, Inc. | QXA | Class II | 2026-03-24 |
| K254166 | MDx-Chex for BCN | Streck | PMN | Class II | 2026-03-23 |
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D | Olympus Medical Systems Corporation | EOB | Class II | 2026-03-20 |
| K260551 | HemosIL Factor V Leiden (APC Resistance V) | Instrumentation Laboratory (IL) Co. | GGW | Class II | 2026-03-20 |
| K254269 | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens | St. shine Optical Co., Ltd. | LPL | Class II | 2026-03-19 |
| K254167 | MDx-Chex for BCY | Streck, LLC | PMN | Class II | 2026-03-17 |
| K251848 | Pentacam® Cornea OCT | Oculus Optikgeräte GmbH | MXK | Class II | 2026-03-13 |
| K252040 | BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes | Becton, Dickinson and Company | JKA | Class II | 2026-03-13 |
| K252385 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | LPL | Class II | 2026-03-13 |
| K254040 | LungFlow Basket Catheter | Free Flow Medical, Inc. | KTI | Class II | 2026-03-12 |
| K260003 | KARL STORZ Mediastinoscopes and Instruments | Karl Storz SE & CO. KG | EWY | Class II | 2026-03-02 |
| K251998 | Atellica CH Diazo Total Bilirubin (D_TBil) | Siemens Healthcare Diagnostics, Inc. | CIG | Class II | 2026-02-27 |
| K252619 | QSCHECK UISACR | Qstag, Inc. | JFY | Class II | 2026-02-20 |
| K253612 | Acclarent AERA Eustachian Tube Balloon Dilation System | Acclarent, Inc. | PNZ | Class II | 2026-02-19 |
| K253539 | Alere NT-proBNP for Alinity i | Axis-Shield Diagnostics, Ltd. | NBC | Class II | 2026-02-18 |
| K254052 | DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal | Alcon Laboratories, Inc. | LPL | Class II | 2026-02-13 |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions | Roche Diagnostics | CFR | Class II | 2026-02-12 |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions | Roche Diagnostics | CEM | Class II | 2026-02-12 |
| K251672 | NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube (NIMEID065); NIM Essence EMG Endotracheal Tube (NIMEID070); NIM Essence EMG Endotracheal Tube (NIMEID075); NIM Essence EMG Endotracheal Tube (NIMEID080) | Medtronic Xomed, Inc. | ETN | Class II | 2026-02-10 |
| K252175 | LANDR Contact LENS Case | Fourth Axis, LLC | LRX | Class II | 2026-02-10 |
| K243348 | Athelas Home | Athelas, Inc. | GKZ | Class II | 2026-02-06 |
| K243979 | Aptiva APS IgA Reagent | Inova Diagnostics, Inc. | MSV | Class II | 2026-02-06 |
| K251507 | INTEGRE LIO | Quantel Medical | HQF | Class II | 2026-02-06 |
| K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. | JLW | Class II | 2026-02-06 |
| K253701 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic Minimed | QJI | Class II | 2026-02-03 |
| K253737 | Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | QBJ | Class II | 2026-02-03 |
| K251281 | Nova Max Creat eGFR Monitoring System | Nova Biomedical Corporation | SHB | Class II | 2026-01-21 |
| K251790 | SeptAlign | Spirair, Inc. | NHB | Class II | 2026-01-16 |
| K252775 | NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg | Hycor Biomedical | DHB | Class II | 2026-01-16 |
| K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) | Medtronic Minimed, Inc. | QFG | Class II | 2026-01-15 |
| K253585 | SmartGuard technology; Predictive Low Glucose technology | Medtronic Minimed, Inc. | QJI | Class II | 2026-01-14 |
| K252339 | iotaSOFT® Insertion System | Iotamotion, Inc. | QQH | Class II | 2026-01-09 |
| K253957 | HemosIL Silica Clotting Time | Instrumentation Laboratory (IL) Co. | GFO | Class II | 2026-01-09 |
| K252749 | Medconn 8K Glycated Hemoglobin Test System | Shanghai Medconn Medical Technology Co., Ltd. | PDJ | Class II | 2026-01-06 |
| K251091 | Lipids | Truvian Health | CHH | Class I | 2025-12-30 |
| K251249 | Tru Hematology Test | Truvian Sciences, Inc. | GKZ | Class II | 2026-01-16 |
| K251353 | Eyer 2 | Phelcom Technologies | HKI | Class II | 2026-01-16 |
| K251157 | Core Metabolic | Truvian Health | CIX | Class II | 2026-01-09 |
| K252206 | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | CGX | Class II | 2026-01-09 |
| K251630 | Atellica IM Total PSA II (tPSAII) | Siemens Healthcare Diagnostics, Inc. | LTJ | Class II | 2026-01-05 |
| K251683 | Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF) | Bruno Vision Care, LLC | LPL | Class II | 2025-12-23 |
| K251800 | Healgen® URS Test Strips | Healgen Scientific,, LLC | JMT | Class I | 2025-12-23 |
| K252493 | NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica) | Hycor Biomedical | DHB | Class II | 2025-12-23 |
| K252633 | UNITY DX (UDX) | Cylite Pty. , Ltd. | OBO | Class II | 2025-12-23 |
| K251074 | Tru Liver Health Test Panel | Truvian Health | CJE | Class II | 2025-12-19 |
| K251152 | DBLG2 | Diabeloop | QJI | Class II | 2025-12-19 |
| K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay | Diazyme Laboratories, Inc. | DFH | Class II | 2025-12-19 |
| K252348 | Tomey Optical Biometer OA-2000 (OA-2000) | Tomey Corporation | MXK | Class II | 2025-12-18 |
| K252762 | HALO AP Dx | Indica Labs, LLC | QKQ | Class II | 2025-11-25 |
| K253039 | AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | Topcon Corporation | HKX | Class II | 2025-11-07 |
| K253188 | CoaguChek XS Plus System | Roche Diagnostics | GJS | Class II | 2025-10-24 |
| K252874 | Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 | Serpex Medical, Inc. | KTI | Class II | 2025-10-08 |
| K252921 | Radial Jaw 4 Pulmonary Biopsy Forceps | Boston Scientific Corporation | BWH | Class II | 2025-09-26 |
| K252682 | LenSx Laser System (8065000944) | Alcon Laboratories, Inc. | OOE | Class II | 2025-09-24 |
| K252540 | ACCUJECT Injector Set 2.1-1P (LP604590) | Medicel AG | MSS | Class I | 2025-09-16 |
| K252580 | iQ200 Series | Beckman Coulter, Inc. | LKM | Class II | 2025-09-10 |
| K252528 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | EOQ | Class II | 2025-09-05 |
| K251371 | Sysmex XR-Series (XR-20) Automated Hematology Analyzer | Sysmex America, Inc. | GKZ | Class II | 2025-06-25 |
| K251402 | LIA-1 Catheter (542-1) | Leadoptik, Inc. | KTI | Class II | 2025-12-19 |
| K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 | Fujirebio Diagnostics,Inc. | OVK | Class II | 2025-12-16 |
| K252120 | Fundus On Phone Non Mydriatic (FOP NM-10) | Remidio Innovative Solutions Private Limited | HKI | Class II | 2025-12-12 |
| K251731 | KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612) | Karl Storz SE & CO. KG | EOQ | Class II | 2025-12-05 |
| K251772 | Navilas Laser System 577sl (156691) | Od-Os GmbH | HQF | Class II | 2025-10-29 |
| K251876 | cleadew GP hydra one | Ophtecs Corporation | MRC | Class II | 2025-10-09 |
| K252163 | Elecsys Phospho-Tau (181P) Plasma | Roche Diagnostics | SET | Class II | 2025-10-08 |
| K252072 | Francisella tularensis Real-time PCR assay | Centers for Disease Control and Prevention | SGA | Class II | 2025-09-30 |
| K251208 | Tuned Self-Fitting Mobile App | Tuned , Ltd. | SCR | Class II | 2025-09-26 |
| K251894 | Himaging Bronchscope System | Himaging Technology (Shanghai) Co., Ltd. | EOQ | Class II | 2025-09-23 |
| K252045 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | EOQ | Class II | 2025-09-23 |
| K251095 | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses | Pegavision Corporation | LPL | Class II | 2025-09-17 |
| K251573 | VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens | Vizionfocus, Inc. | LPL | Class II | 2025-09-10 |
| K251404 | Quantra QStat Cartridge | Hemosonics, LLC | QFR | Class II | 2025-08-25 |
| K251440 | CRYOcheck Chromogenic Factor VIII | Precision Biologic, Inc. | GGP | Class II | 2025-08-25 |
| K251087 | Blood Volume Analyzer (200) | Daxor Corporation | JWO | Class II | 2025-08-04 |
| K251968 | HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL | Instrumentation Laboratory (IL) Co. | KQJ | Class II | 2025-07-24 |
| K251564 | microINR System | Iline Microsystems, S.L. | GJS | Class II | 2025-07-21 |
| K250943 | Sysmex XR-Series (XR-10) Automated Hematology Analyzer | Sysmex America, Inc. | GKZ | Class II | 2025-06-25 |
| K250968 | PathPresenter Clinical Viewer | Pathpresenter Corporation | QKQ | Class II | 2025-06-20 |
| K250965 | Automated Blood Coagulation Analyzer CN-Series (CN-6000) | Sysmex America, Inc. | JPA | Class II | 2025-06-02 |
| K251024 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | Haemonetics | JPA | Class II | 2025-04-30 |
| K241717 | E1000 Dx Digital Pathology Solution | Shandon Diagnostics Limited | PSY | Class II | 2025-02-28 |
| K241973 | SmartIPL_NI System | Lumenis Be, Ltd. | GEX | Class II | 2026-09-19 |
| K250129 | AViTA Breast Pump | Avita Corporation | HGX | Class II | 2026-06-11 |
| K250781 | Embryo Predict | Alife Health | PBH | Class II | 2026-05-15 |
| K250814 | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB | Zeus Scientific | OBE | Class II | 2026-05-08 |
| K250501 | System Sophi | This AG | HQC | Class II | 2025-11-14 |
| K250516 | SMART M-CELL PRP Concentration System | Miracell Co., Ltd. | QBV | Class I | 2026-04-02 |
| K250518 | SMART M-CELL Bone Marrow Concentration System | Miracell Co., Ltd. | QBV | Class I | 2026-04-02 |
| K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | Siemens Healthcare Diagnostics, Inc. | JNL | Class II | 2025-12-04 |
| K250863 | FUJIFILM Ultrasonic Endoscope EB-710US | Fujifilm Corporation | EOQ | Class II | 2025-12-12 |
| K243449 | INFINITT DPS | Infinitt Healthcare Co., Ltd. | QKQ | Class II | 2025-12-09 |
| K250666 | Alegria Flash CTD Screen | Zeus Scientific | LLL | Class II | 2025-10-22 |
| K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser | The Binding Site Group , Ltd. | SGG | Class II | 2025-10-17 |
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II | Siemens Healthcare Diagnostics, Inc. | JZO | Class II | 2025-10-17 |
| K250364 | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens | St. shine Optical Co., Ltd. | LPL | Class II | 2025-10-07 |
| K244009 | Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable) | Yung Sheng Optical Co., Ltd. | LPL | Class II | 2025-09-25 |
| K241868 | xR IVD | Tempus AI, Inc. | PZM | Class II | 2025-09-19 |
| K250408 | Alegria Flash ENA Screen | Zeus Scientific | LLL | Class II | 2025-09-19 |
| K250770 | Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. | HKI | Class II | 2025-09-04 |
| K250003 | GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) | Geneseeq Technology, Inc. | PZM | Class II | 2025-08-29 |
| K250874 | Sunrise | Sunrise SA | QRS | Class II | 2025-08-29 |
| K243600 | 3nethra neo HD FA; 3nethra neo HD | Forus Health Pvt.Ltd | HKI | Class II | 2025-08-14 |
| K243391 | AISight Dx | PathAI, Inc. | QKQ | Class II | 2025-06-26 |
| K243395 | MICOR 700 with Auto I/A | Carl Zeiss Meditec Cataract Technology, Inc. | HQC | Class II | 2025-08-08 |
| K250495 | MINI VP1 (PL67_F); MINI VP1 (PL61_F) | Avizor S.A. | LRX | Class II | 2025-08-01 |
| K242706 | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio | Fujirebio Diagnostics,Inc. | SET | Class II | 2025-05-16 |
| K242855 | P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) | E.O.S Co., Ltd. | LPL | Class II | 2025-07-30 |
| K250553 | Tomey Cornea/Anterior Segment OCT (CASIA2) | Tomey Corporation | OBO | Class II | 2025-07-18 |
| K243868 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | LPL | Class II | 2025-07-02 |
| K243144 | X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. | JOY | Class II | 2025-06-27 |
| K250143 | Digital Prism Correction Feature (DPCF) | Apple, Inc. | SCW | Class I | 2025-06-23 |
| K242981 | Atellica IM Thyroglobulin (Tg) | Siemens Healthcare Diagnostics, Inc. | MSW | Class II | 2025-06-20 |
| K243014 | EyeQ nanoECP | Eyeq, Inc. | HQF | Class II | 2025-06-18 |
| K242801 | MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185) | Carl Zeiss Meditec Cataract Technology, Inc. | HQC | Class II | 2025-06-11 |
| K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer | Bonraybio Co., Ltd. | POV | Class II | 2025-05-30 |
| K242545 | RadiForce MX317W-PA | Eizo Corporation | PZZ | Class II | 2025-05-23 |
| K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit | The Binding Site Group , Ltd. | DFH | Class II | 2025-05-23 |
| K250414 | CaloPix | Tribun Health | QKQ | Class II | 2025-05-14 |
| K242388 | LensHooke X12 PRO Semen Analysis System | Bonraybio Co., Ltd. | POV | Class II | 2025-05-09 |
| K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) | Zeus Scientific | MOB | Class II | 2025-05-07 |
| K243114 | SQA-iOw Sperm Quality Analyzer | Medical Electronic Systems , Ltd. | POV | Class II | 2025-05-02 |
| K242531 | NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz | Hycor Biomedical | DHB | Class II | 2025-04-23 |
| K242170 | K-ASSAY CRP (Ver.2) | Kamiya Biomedical Company, LLC | DCK | Class II | 2025-04-18 |
| K242952 | INNOVANCE Antithrombin | Siemens Healthcare Diagnostic Products GmbH | JBQ | Class II | 2025-03-28 |
| K242244 | Viewer+ | Lumea, Inc. | QKQ | Class II | 2025-03-14 |
| K243822 | BioFire Warrior Panel; BioFire Warrior Panel Control Kit | Biofire Defense, LLC | PRD | Unclassified | 2025-03-12 |
| K243871 | Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. | PSY | Class II | 2025-03-06 |
| K243543 | microINR System | Iline Microsystems, S.L. | GJS | Class II | 2025-02-27 |
| K250218 | Xpert® FII & FV | Cepheid | NPR | Class II | 2025-02-21 |
| K243283 | Alinity h-series System | Abbott Laboratories | GKZ | Class II | 2025-02-20 |
| K240402 | Cito CBC System | Cytochip, Inc. | GKZ | Class II | 2025-02-03 |
| K243374 | HemosIL CL HIT-IgG(PF4-H) | Instrumentation Laboratory (IL) Co. | LCO | Class II | 2025-01-28 |
| K241220 | Tina-quant Lipoprotein(a) Gen.2 Molarity | Roche Diagnostics Operations | DFC | Class II | 2025-01-24 |
| K241232 | Galen Second Read | Ibex Medical Analytics , Ltd. | QPN | Class II | 2025-01-24 |
| K243858 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | Haemonetics Corporation | JPA | Class II | 2025-01-15 |
| K241273 | FullFocus | Paige.Ai, Inc. | QKQ | Class II | 2025-01-09 |
| K241456 | GlutenID Celiac Genetic Health Risk Test | Targeted Genomics, LLC | PTA | Class II | 2025-01-07 |
| K233119 | 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T | Shenzhen Beacon Display Technology Co., Ltd. | PZZ | Class II | 2024-12-28 |
| K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM Reagent | Inova Diagnostics, Inc. | MID | Class II | 2024-12-17 |
| K242783 | Roche Digital Pathology Dx | Ventana Medical Systems, Inc. | PSY | Class II | 2024-12-17 |
| K242848 | Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. | PSY | Class II | 2024-12-10 |
| K241871 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | PSY | Class II | 2024-12-02 |
| K241628 | YO Home Sperm Test | Medical Electronic Systems , Ltd. | POV | Class II | 2024-11-29 |
| K221326 | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | LCP | Class II | 2024-11-22 |
| K243222 | BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) | Biofire Diagnostics, LLC (Biomerieux) | QDS | Class II | 2024-11-06 |
| K240303 | MetaLite DX Digital Pathology Software | Jellox Biotech, Inc. | QKQ | Class II | 2024-10-28 |
| K240315 | INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) | Siemens Healthcare Diagnostics Products GmbH | QLU | Class II | 2024-10-10 |
| K242127 | ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) | Instrumentation Laboratory (IL) Co. | GKP | Class II | 2024-08-16 |
| K240469 | Access TPO Antibody | Beckman Coulter, Inc. | JZO | Class II | 2024-08-09 |
| K240252 | UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System | Beckman Coulter, Inc. | GKZ | Class II | 2024-07-05 |
| K240987 | Access sTfR | Beckman Coulter, Inc. | DDG | Class II | 2024-07-03 |
| K240996 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | JNL | Class II | 2024-07-03 |
| K240927 | Access Thyroglobulin | Beckman Coulter, Inc. | MSW | Class II | 2024-06-28 |
| K241423 | Access Thyroglobulin | Beckman Coulter, Inc. | MSW | Class II | 2024-06-07 |
| K232416 | AUTION EYE AI-4510 Urine Particle Analysis System | Arkray, Inc. | LKM | Class II | 2024-05-03 |
| K233204 | Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. | PSY | Class II | 2024-06-24 |
| K232879 | Roche Digital Pathology Dx (VENTANA DP 200) | Ventana Medical Systems, Inc. | PSY | Class II | 2024-06-14 |
| K231151 | Kenota 1 Total IgE; Kenota 1 (instrument) | Kenota, Inc. | DGC | Class II | 2024-05-31 |
| K233126 | aetherSlide | Aetherai Co., Ltd. | QKQ | Class II | 2024-05-30 |
| K232946 | Yumizen H2500 | HORIBA ABX SAS | GKZ | Class II | 2024-05-21 |
| K240479 | Access OV Monitor | Beckman Coulter, Inc. | LTK | Class II | 2024-05-10 |
| K240403 | Access BR Monitor | Beckman Coulter, Inc. | MOI | Class II | 2024-05-09 |
| K232833 | HALO AP Dx | Indica Labs, Inc. | PSY | Class II | 2024-05-07 |
| K240636 | HemoScreen Hematology Analyzer | Pixcell Medical Technologies | GKZ | Class II | 2024-05-02 |
| K240279 | VIDAS TBI (GFAP, UCH-L1) | bioMerieux, Inc. | QAT | Class II | 2024-05-01 |
| K232317 | UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips | Urit Medical Electronic Co., Ltd. | JIO | Class II | 2024-04-26 |
| K240182 | Access EPO | Beckman Coulter, Inc. | GGT | Class II | 2024-04-22 |
| K232202 | Aperio GT 450 DX | Leica Biosystems Imaging, Inc. | PSY | Class II | 2024-04-16 |
| K232208 | Sectra Digital Pathology Module (Version 3.3) | Sectra AB | PSY | Class II | 2024-04-16 |
| K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument | Sebia | GKA | Class II | 2024-04-04 |
| K232018 | Citrated: K, KH, RTH, FFH | Haemonetics Corporation | JPA | Class II | 2024-03-29 |
| K234143 | i-STAT TBI Cartridge with the i-STAT Alinity System | Abbott Point of Care | QAT | Class II | 2024-03-27 |
| K240045 | QStat Cartridge | Hemosonics, LLC | QFR | Class II | 2024-03-27 |
| K234052 | Access Ferritin | Beckman Coulter, Inc. | JMG | Class II | 2024-03-20 |
| K230802 | Xprecia Prime Coagulation System | Universal Biosensors Pty, Ltd. | GJS | Class II | 2024-03-15 |
| K233946 | IMMULITE® 2000 BR-MA | Siemens Healthcare Diagnostics Products, Ltd. | MOI | Class II | 2024-03-13 |
| K231601 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 | Sebia | DFH | Class II | 2024-02-23 |
| K230839 | Concentriq Dx | Proscia, Inc. | PSY | Class II | 2024-02-08 |
| K232057 | BÜHLMANN fCAL® turbo and CALEX® Cap | Bühlmann Laboratories AG | NXO | Class II | 2024-02-06 |
| K231290 | Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit | The Binding Site, Ltd. | DFH | Class II | 2024-01-24 |
| K233790 | ACL TOP 970 CL | Instrumentation Laboratory | JPA | Class II | 2023-12-29 |
| K233027 | NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | PSY | Class II | 2023-12-22 |
| K230887 | Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer | Sysmex America, Inc. | GKZ | Class II | 2023-12-21 |
| K230852 | HemosIL Chromogenic Factor IX | Instrumentation Laboratory Company | GGP | Class II | 2023-12-13 |
| K210017 | ACTOnco, ACTOnco IVD | Act Genomics | PZM | Class II | 2022-12-23 |
| K222601 | FilmArray Pneumonia Panel plus | Biofire Diagnostics, LLC | QDS | Class II | 2022-10-27 |
| K212361 | Novo | PathAI, Inc. | QKQ | Class II | 2022-08-11 |
| K213883 | NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | PSY | Class II | 2022-09-27 |
| K210811 | Dynamyx Digital Pathology Software | Inspirata, Inc. | QKQ | Class II | 2022-03-01 |
| K212176 | CINtec Histology | Ventana Medical Systems, Inc. | PRB | Class II | 2021-12-10 |
| K202304 | NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) | Nyu Langone Medical Center | PZM | Class II | 2021-07-14 |
| K203845 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | PSY | Class II | 2021-09-17 |
| K203364 | MDPC-8127 | Barco N.V. | PSY | Class II | 2021-04-15 |
| K200009 | Adaptive Biotechnologies clonoSEQ Assay | Adaptive Biotechnologies Corporation | QDC | Class II | 2020-08-05 |
| K201005 | FullFocus | Paige.Ai, Inc. | QKQ | Class II | 2020-07-15 |
| K192063 | PGDx elio tissue complete | Personal Genome Diagnostics | PZM | Class II | 2020-04-24 |
| K193054 | Sectra Digital Pathology Module | Sectra AB | QKQ | Class II | 2020-03-31 |
| K190661 | Omics Core | Nanthealth, Inc. | PZM | Class II | 2019-11-09 |
| K192259 | Philips IntelliSite Pathology Solution | Philips Electronics Nederland B.V. | PSY | Class II | 2019-09-20 |