Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 35
- Latest Decision
- 2021-02-23
Clearances · page 16 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K202339 | Molekule Air Mini, Molekule Air Mini + | Molekule, Inc. | FRA | Class II | 2021-02-23 |
| K202432 | MiniLoad Syringe | Ocuject, LLC | FMF | Class II | 2021-02-19 |
| K202687 | Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60 | Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. | FLL | Class II | 2021-02-18 |
| K201412 | BEGO SEMADOS Tr 58350; BEGO SEMADOS RS/RSX-Line Tray Plus, BEGO Semados Tr 58349; BEGO Semados Tr 58348, BEGO Semados DSTr 58356; Drill Stop Tray Plus (RS/RSX-Line), BEGO SEMADOS PKTr 58357; Prosthetic Kit | Bego Implant Systems GmbH & Co. KG | KCT | Class II | 2021-02-18 |
| K210443 | PLPT LDV (Low Dead Volume) Sterile Syringe | Poonglim Pharmatech, Inc. | QNQ | Class II | 2021-02-16 |
| K210444 | EZ-Injec LDV Sterile Safety Needle | Poonglim Pharmatech, Inc. | QNS | Class II | 2021-02-16 |
| K203702 | Vinyl Examination Gloves (Yellow) | Xinying Trading Co., Ltd. | LYZ | Class I | 2021-02-12 |
| K201628 | Panda iRes Warmer, Giraffe Warmer | GE Healthcare | FMT | Class II | 2021-02-12 |
| K202368 | Infrared Thermometer | Shandong Bittel Intelligent Technology Co., Ltd. | FLL | Class II | 2021-02-12 |
| K203191 | LYDUS Nitrile Examination Gloves, Powder Free | Nathan Trading Co., Ltd. | LZA | Class I | 2021-02-12 |
| K201536 | Infrared Forehead Thermometer | Hangzhou Qingyuan Medical Equipment Technology Co., Ltd. | FLL | Class II | 2021-02-10 |
| K203069 | HydroMID | Access Vascular, Inc. | FOZ | Class II | 2021-02-08 |
| K193422 | Easydrip Pen Needle, Easydrip Plus Pen Needle | Sandstone Medical (Suzhou), Inc. | FMI | Class II | 2021-02-02 |
| K202524 | Standard Sterilizable Tray | Implant Direct Sybron Manufacturing, LLC | KCT | Class II | 2021-01-28 |
| K203453 | BD Hypodermic Syringe | Becton, Dickinson and Company | FMF | Class II | 2021-01-25 |
| K203747 | Non-Contact Forehead Thermometer (Models UT306H & UT308H) | Uni-Trend Technology (China) Co., Ltd. | FLL | Class II | 2021-01-25 |
| K203656 | Non-Contact Forehead Thermometer (UT30H) | Uni-Trend Technology (China) Co., Ltd. | FLL | Class II | 2021-01-22 |
| K200037 | Piccolo Medical SmartPICC System | Piccolo Medical, Inc. | LJS | Class II | 2021-01-22 |
| K203189 | AEROCURE-MD | Aerobiotix, Inc. | FRA | Class II | 2021-01-21 |
| K202672 | Precision Delivery Infusion Set | Quest Medical, Inc. | FPA | Class II | 2021-01-21 |
| K201930 | Nanum Syringe | Nanum Company Co., Ltd. | FMF | Class II | 2021-01-17 |
| K201579 | Infrared Thermometer | Shenzhen Xunwei Industrial Co., Ltd. | FLL | Class II | 2021-01-15 |
| K201582 | Non-contact Electronic Forehead Infrared Thermometer | Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. | FLL | Class II | 2021-01-15 |
| K202721 | Celerity 20 Steam Biological Indicator for IUSS | STERIS Corporation | FRC | Class II | 2021-01-08 |
| K202622 | Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate | O&M Halyard, Inc. | LZA | Class I | 2021-01-07 |
| K202544 | Instylla Delivery Kit | Instylla, Inc. | FMF | Class II | 2021-01-07 |
| K201872 | NeutrArt | Asset Medikal Tasarim As. | FPA | Class II | 2021-01-05 |
| K202791 | iHealth Clinical Digital Thermometer | Andon Health Co, Ltd. | FLL | Class II | 2021-01-05 |
| K200159 | Non-contact Infrared Body Thermometer, model:HTD8823US | Hetaida Technology Co., Ltd. | FLL | Class II | 2021-01-05 |
| K193273 | Insulin Syringe | Promisemed Hangzhou Meditech Co., Ltd. | FMF | Class II | 2021-01-05 |
| K202681 | Promisemed Covered Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | FMI | Class II | 2020-12-31 |
| K202690 | Remunity Pump for Remodulin (treprostinil) Injection | Deka Research and Development | QJY | Class II | 2020-12-30 |
| K202268 | CrossRoads Tray System | Crossroads Extremity Systems, LLC | KCT | Class II | 2020-12-30 |
| K200321 | Novaerus NV1050 | Novaerus Us, Inc. | FRF | Class II | 2020-12-28 |
| K200970 | Self-Contained Biological Indicator | True Indicating, LLC | FRC | Class II | 2020-12-28 |
| K200631 | DeRoyal Temperature Monitoring Probe | Deroyal Industries, Inc. | FLL | Class II | 2020-12-23 |
| K202005 | NovoFine Plus 32G Tip x 4 mm | Novo Nordisk, Inc. | FMI | Class II | 2020-12-19 |
| K201980 | Infrared Thermometer | Contec Medical Systems Co.,Ltd | FLL | Class II | 2020-12-18 |
| K191978 | Fever Garde | Hubdic Co., Ltd. | FLL | Class II | 2020-12-18 |
| K201075 | BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter | Becton, Dickinson and Company | FOZ | Class II | 2020-12-18 |
| K192770 | S dispensing line | Aea Srl | FMF | Class II | 2020-12-17 |
| K201031 | NRFit® Caps, Male and Female Neuraxial Tip Caps | International Medical Industries, Inc. | QEH | Class II | 2020-12-16 |
| K202222 | Irrisept Wound Debridement and Cleansing System | Irrimax Corporation | FQH | Class II | 2020-12-14 |
| K201284 | Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use | Set Medikal Sanayi VE Ticaret Anonim Sirketi | FMF | Class II | 2020-12-14 |
| K203458 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | JOJ | Class II | 2020-12-11 |
| K200996 | 3M Attest Rapid Readout Biological Indicator | 3M Company | FRC | Class II | 2020-12-11 |
| K203285 | 3M Comply Hydrogen Peroxide Indicator Tape 1228 | 3M Company | JOJ | Class II | 2020-12-10 |
| K203321 | Cystoject Syringe Lever | Urogen Pharma, Ltd. | QBL | Class II | 2020-12-09 |
| K200781 | Infrared Body Thermometer | Heitaida Technology Co., Ltd. | FLL | Class II | 2020-12-09 |
| K201469 | Mini Spike Plus 6/8R | B.Braun Medical, Inc. | LHI | Class II | 2020-12-09 |
| K203284 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator | 3M Company | QKM | Class II | 2020-12-07 |
| K201864 | YUWELL Infrared Thermometer | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | FLL | Class II | 2020-12-07 |
| K201977 | TempTraq | Blue Spark Technologies, Inc. | FLL | Class II | 2020-12-03 |
| K202565 | WAVICIDE-OPA MEC Indicator | Serim Research Corporation | JOJ | Class II | 2020-12-02 |
| K202270 | EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device | K1 Medical, LLC | KCT | Class II | 2020-12-02 |
| K202384 | Palm Care Blue Nitrile Examination Gloves Powder Free | Hi-Care Thai Gloves Co. , Ltd. | LZA | Class I | 2020-12-02 |
| K202377 | Palm Care Latex Examination Powder Free Gloves | Hi-Care Thai Gloves Co. , Ltd. | LYY | Class I | 2020-12-01 |
| K202416 | Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid | Kimberly Clark Corporation | LZA | Class I | 2020-11-30 |
| K202682 | Promisemed Triple Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | FMI | Class II | 2020-11-24 |
| K202515 | NUVO Implant System NUVO Instrument Kit Cases | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | KCT | Class II | 2020-11-24 |
| K193158 | ACENT Central Venous Catheter | Global Medikit Limited | FOZ | Class II | 2020-11-24 |
| K193621 | Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) | Dongguan E-Test Technology Co., Ltd. | FLL | Class II | 2020-11-23 |
| K192860 | Sapphire Infusion Pump, Sapphire administration sets | Q Core Medical , Ltd. | FRN | Class II | 2020-11-19 |
| K193010 | Liebel-Flarsheim IBP Transfer Set | Liebel-Flarsheim Company, LLC | PQH | Class II | 2020-11-18 |
| K200336 | Tyvek Sterilization Pouches with Chevron Seal | Andersen Sterilizers, Inc. | FRG | Class II | 2020-11-12 |
| K201523 | Sharps container | Zhejiang Gongdong Medical Technology Co., Ltd. | MMK | Class II | 2020-11-12 |
| K200334 | AN1036 Dosimeter | Andersen Sterilizers, Inc. | JOJ | Class II | 2020-11-12 |
| K192978 | EOGas 4 Ethylene Oxide Gas Sterilizer | Andersen Sterilizers, Inc. | FLF | Class II | 2020-11-12 |
| K192980 | EOGas 4 Endo-SteriTest | Andersen Sterilizers, Inc. | FRC | Class II | 2020-11-12 |
| K200335 | Sterisheet Sterilization Wrap | Andersen Sterilizers, Inc. | FRG | Class II | 2020-11-12 |
| K193190 | BD PureHub Disinfecting Cap | Becton, Dickinson and Company | QBP | Class II | 2020-11-09 |
| K203061 | Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 and HC-1500),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-800 and HC-1000),Evolution Automated Loading and Unloading System (ALUS) | STERIS Corporation | FLE | Class II | 2020-11-06 |
| K200017 | Eclipse DermaFlex Cannula | Eclipse Medcorp, LLC | FMI | Class II | 2020-11-05 |
| K201877 | OtoSet- Ear Cleaning System | Safkan, Inc. | KYZ | Class I | 2020-11-05 |
| K182084 | Sweden & Martina Surgical Tray (Model ZSHORTY-INT) | Sweden & Martina S.P.A. | KCT | Class II | 2020-11-04 |
| K202105 | OsteoMed ExtremiFix Mini & Small System Tray | Osteomed, LLC | KCT | Class II | 2020-10-29 |
| K200425 | Female Luer Lock Cap | Medsafety Solutions, LLC | FPA | Class II | 2020-10-29 |
| K200299 | Curos Jet Disinfecting Cap | 3M Company | QBP | Class II | 2020-10-29 |
| K200150 | Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl) | Medline Industries, Inc. | LZA | Class I | 2020-10-26 |
| K202179 | Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs) | Medline Industries, Inc. | LYZ | Class I | 2020-10-26 |
| K202071 | SURGIPHOR Wound Irrigation System | Orthophor, LLC | FQH | Class II | 2020-10-23 |
| K193088 | MaxZero Extension Sets with Needle-Free Connector(s) | Carefusion, Inc. | FPA | Class II | 2020-10-23 |
| K201843 | Infrared ear and forehead thermometer, model YI-100 | Wenzhou Yosun Medical Technology Co.,Ltd | FLL | Class II | 2020-10-23 |
| K201688 | S.I.N. Instrument Kits | S.I.N. - Sistema DE Implante Nacional S.A. | KCT | Class II | 2020-10-21 |
| K201415 | Vial2Bag Advanced 20mm Admixture Device | West Pharmaceutical Services Az, Inc. | LHI | Class II | 2020-10-21 |
| K201816 | ARTHROTAP | Accuro Technologies, Inc. | FMF | Class II | 2020-10-16 |
| K202010 | Disposable Vinyl Glove | Better Health Medical Products Co., Ltd. | LYZ | Class I | 2020-10-16 |
| K202340 | Droplet Pen Needle 30G & 33G | Htl-Strefa S.A | FMI | Class II | 2020-10-15 |
| K200633 | Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove | 0 & M Halyard, Inc. | LZC | Class I | 2020-10-11 |
| K200661 | Steripath Micro Blood Collection System | Magnolia Medical Technologies, Inc. | FPA | Class II | 2020-10-08 |
| K200802 | Infrared Thermometer | Shenzhen Urion Technology Co., Ltd. | FLL | Class II | 2020-10-07 |
| K200031 | Neonatal Phototherapy System | Avalon Biomedical (Shenzhen) Limited | LBI | Class II | 2020-10-05 |
| K201161 | Infrared Thermometer Model E127 | Bioland Technology, Ltd. | FLL | Class II | 2020-10-02 |
| K200710 | Infrared PT2L Digital No-Touch Thermometer | Andon Health Co, Ltd. | FLL | Class II | 2020-10-01 |
| K200051 | PUGGLE Enteral Feeding Pump and Feeding Set | Amsino International, Inc. | LZH | Class II | 2020-09-25 |
| K201717 | BD Cathena Safety IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | FOZ | Class II | 2020-09-22 |
| K200843 | Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs | O&M Halyard, Inc. | LZA | Class I | 2020-09-22 |
| K192375 | Intellifuse Administration and Intellifuse Blood Administration Sets | Smiths Medical Asd, Inc. | FPA | Class II | 2020-09-18 |
| K201390 | Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) | Medline Industires, Inc. | LZC | Class I | 2020-09-18 |
| K191639 | TK Insulin Syringe with/without Saftey Retractable Device | Anhui Tiankang Medical Technology Co., Ltd. | MEG | Class II | 2020-09-11 |
15,723 clearances in the General Hospital panel. Data: openFDA.