Review Panel
Neurology FDA 510(k) Clearances & Devices
- Cleared Devices
- 6,130
- Product Codes (page)
- 41
- Latest Decision
- 2025-10-27
Clearances · page 3 of 62
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K250520 | OsteoCentric Navigated Instruments System | Osteocentric Technologies, Inc. | OLO | Class II | 2025-10-27 |
| K250297 | TECHFIT Patient-Specific Cranial System | Techfit Digital Surgery, Inc. | GWO | Class II | 2025-10-27 |
| K231897 | NeuroAlign software | Medivis, Inc. | HAW | Class II | 2025-10-21 |
| K251282 | StealthStation S8 Spine Software | Medtronic Navigation, Inc. | OLO | Class II | 2025-10-17 |
| K251832 | InZone IST Detachment System; IZDS Connecting Cable | Stryker Neurovascular | HCG | Class II | 2025-10-17 |
| K250227 | JOVS Electric Stimulation Beauty Device (JE2) | Shenzhen Qianyu Technology Co., Ltd. | NFO | Class II | 2025-10-17 |
| K251034 | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44) | Shenzhen Nuon Medical Equipment Co., Ltd. | NFO | Class II | 2025-10-12 |
| K252544 | TMINI Miniature Robotic System | THINK Surgical, Inc. | OLO | Class II | 2025-10-10 |
| K251927 | Zeta Navigation System (ZNS131-US) | Zeta Surgical, Inc. | SGE | Class II | 2025-10-10 |
| K251366 | EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) | Nihon Kohden Corporation | OLT | Class II | 2025-10-09 |
| K252553 | Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | NFO | Class II | 2025-10-09 |
| DEN240073 | PainChek (PainChek Adult) | Painchek Limited (Ltd.) | SGB | Class II | 2025-10-06 |
| K251639 | xvision Spine system | Augmedics, Ltd. | SBF | Class II | 2025-10-03 |
| K252054 | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | SBF | Class II | 2025-09-29 |
| K252051 | allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) | Tulavi Therapeutics, Inc. | SBG | Class II | 2025-09-29 |
| K252700 | Optima Coil System (Optima Packing Coil System) | Balt USA, LLC | HCG | Class II | 2025-09-26 |
| K251971 | RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer | Stryker Instruments | OLO | Class II | 2025-09-25 |
| K252662 | UniBur | Nakanishi, Inc. | HBE | Class II | 2025-09-19 |
| K251649 | Sunny Plus (Sunny) | ShenB Co., Ltd. | NFO | Class II | 2025-09-18 |
| K251780 | iGPS Navigation Instruments | SI-BONE, Inc. | OLO | Class II | 2025-09-15 |
| K250689 | CloudTMS Edge | Teleemg, LLC | OBP | Class II | 2025-09-14 |
| K251449 | BrainsWay Deep TMS System | Brainsway , Ltd. | OBP | Class II | 2025-09-13 |
| K252562 | Spine & Trauma Navigation Instruments | Brainlab AG | OLO | Class II | 2025-09-12 |
| K251316 | Mazor X System / Mazor X Stealth Edition | Mazor Robotics , Ltd. | OLO | Class II | 2025-09-11 |
| K252530 | OptiVu Shoulder | Mr Surgical Solutions, LLC | SBF | Class II | 2025-09-10 |
| K252524 | Quadsense (Quadsense and Quadsense Pro) | Eventum Orthopaedics, Ltd. | ONN | Class II | 2025-09-09 |
| K251957 | Coaptium Connect with Tissium Light | Tissium SA | SFD | Class II | 2025-09-08 |
| K251317 | SOLOPASS 2.0 System | Intravent Medical Partners | HAW | Class II | 2025-09-05 |
| K251737 | NextAR(TM) Shoulder Platform | Medacta International S.A. | SBF | Class II | 2025-09-04 |
| K243700 | Apollo TMS Therapy System | Mag & More GmbH | OBP | Class II | 2025-09-04 |
| K250893 | Ball Joint Guide Array (66295) | Bayer Medical Care, Inc. | HAW | Class II | 2025-09-04 |
| K251726 | SignalNED System (Model RE) | Forest Devices, Inc. | OMC | Class II | 2025-09-03 |
| K251909 | NeurotriS (SX2500); NeurotriS (SX3800) | A-1 Engineering | NFO | Class II | 2025-09-03 |
| K251480 | PV01 PVDF Effort Sensor | Neurotronics, LLC | SFK | Class II | 2025-08-29 |
| K250285 | NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL | Raumedic AG | GWM | Class II | 2025-08-29 |
| K251429 | OTC 4-Channel Rechargeable TENS Unit | Changsha Anxiang Medical Technology Co., Ltd. | NUH | Class II | 2025-08-28 |
| K251246 | Sparrow Ascent | Spark Biomedical, Inc. | PZR | Class II | 2025-08-25 |
| K243709 | NeuroEars-Anna | Neuroears, Inc. | GWN | Class II | 2025-08-25 |
| K250784 | Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122) | Shenzhen Yicai Health Technology Co., Ltd. | NUH | Class II | 2025-08-21 |
| DEN250002 | Delphi-MD System | Quantalx Neuroscience, Ltd. | SFN | Class II | 2025-08-20 |
| K243539 | Apollo TMS Therapy System | Mag & More GmbH | OBP | Class II | 2025-08-18 |
| K250167 | Evolution Spine Navigation Instruments | Evolution Spine | OLO | Class II | 2025-08-18 |
| K252236 | CP Relief Wand Rx - TENS/NMES | N & C Holdings, LLC | GZJ | Class II | 2025-08-15 |
| K251243 | OneRF Trigeminal Nerve Radiofrequency Probes | Neuroone Medical Technologies Corp. | GXI | Class II | 2025-08-15 |
| K251519 | RelieVRx (Pico G3) | Appliedvr | QRA | Class II | 2025-08-13 |
| K250841 | Electrotherapy Electrodes | Baisheng Medical Co., Ltd. | GXY | Class II | 2025-08-13 |
| K251125 | MagVenture TMS Therapy System | Tonica Elektronik A/S | OBP | Class II | 2025-08-11 |
| K243531 | Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology | Integra Lifesciences Production Corporation | JXG | Class II | 2025-08-08 |
| K252170 | OptiVu Shoulder | Mr Surgical Solutions, LLC | SBF | Class II | 2025-08-08 |
| K251119 | MagVenture TMS Therapy System | Tonica Elektronik A/S | OBP | Class II | 2025-08-08 |
| K251247 | GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03) | Boston Scientific Neuromodulation Corporation | GXD | Class II | 2025-08-07 |
| K250309 | BTL-199 | BTL Industries, Inc. | QPL | Class II | 2025-08-07 |
| K243552 | Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762) | Integra Lifesciences Production Corporation | JXG | Class II | 2025-08-06 |
| K250477 | NextAR(TM) Spine | Medacta International S.A. | SBF | Class II | 2025-07-31 |
| K251574 | Sleep Watch | Ambulatory Monitoring, Inc. | LEL | Class II | 2025-07-31 |
| K252032 | T65 (9016E061-) | Tonica Elektronik A/S | OBP | Class II | 2025-07-30 |
| K251060 | CORUS Navigation System-GX | Providence Medical Technology, Inc. | OLO | Class II | 2025-07-30 |
| K251187 | 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) | Changsha Anxiang Medical Technology Co., Ltd. | NUH | Class II | 2025-07-28 |
| K250334 | Fusion Craniofacial Implant; Fusion Skull Implant | Kelyniam Global, Inc. | GWO | Class II | 2025-07-25 |
| K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) | Innovasis, Inc. | OLO | Class II | 2025-07-23 |
| K251505 | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) | Alafair Biosciences | JXI | Class II | 2025-07-22 |
| K252218 | MF SC GEN2 Facial Toning System | Micro Current Technology, Inc. | NFO | Class II | 2025-07-18 |
| K251175 | VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) | Alafair Biosciences | JXI | Class II | 2025-07-17 |
| K243782 | StimTrial Neuromodulation System | Bioventus, LLC | GZF | Class II | 2025-07-16 |
| K243199 | NightWatch+ US | Livassured BV | POS | Class II | 2025-07-12 |
| K251472 | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System | Inion OY | HBW | Class II | 2025-07-11 |
| K244004 | Microcurrent Facial Device (CEC101, EE0101, EEI101) | Shenzhen Dachi Communication Co., Ltd. | NFO | Class II | 2025-07-10 |
| K250108 | OptiVu Shoulder | Mr Surgical Solutions, LLC | SBF | Class II | 2025-07-09 |
| K250505 | EZ-FIDUCIALS | Phasor Health, LLC | HAW | Class II | 2025-07-09 |
| K241525 | ExcelsiusXR | Globus Medical, Inc. | SBF | Class II | 2025-07-08 |
| K243678 | TalisMann Neuromodulation System | Bioventus, LLC | GZF | Class II | 2025-07-03 |
| K250286 | Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) | The Magstim Company Limited | QPL | Class II | 2025-07-03 |
| K250096 | Felix NeuroAI System | Fasikl Incorporated | QBC | Class II | 2025-07-01 |
| K251210 | Ampa One System (AMPA-001) | Neuromodulatory Devices & Applications | OBP | Class II | 2025-06-27 |
| K242974 | External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters | Sophysa | JXG | Class II | 2025-06-20 |
| K250877 | TMINI Miniature Robotic System | THINK Surgical, Inc. | OLO | Class II | 2025-06-20 |
| K243053 | Navient Image Guided Navigation System (ENT) (955-NC-NC) | Claronav | PGW | Class II | 2025-06-20 |
| K250515 | EpiMonitor | Empatica S.r.l. | POS | Class II | 2025-06-19 |
| K242933 | SPINEART Navigation Instrument System | Spineart SA | OLO | Class II | 2025-06-18 |
| DEN240066 | COAPTIUM Connect with TISSIUM LIGHT | Tissium SA | SFD | Class II | 2025-06-17 |
| K242759 | Geister K-Rex rongeurs | Geister Medizin Technik GmbH | HAE | Class II | 2025-06-06 |
| K242704 | Synchrony (20-3000) | Synapse Biomedical, Inc. | GZI | Class II | 2025-06-05 |
| K242464 | Stealth Spine Clamps; ModuLeX Shank Mounts | Medtronic Navigation, Inc. | OLO | Class II | 2025-06-05 |
| K251433 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1) | Surgify Medical OY | HBE | Class II | 2025-06-04 |
| K250879 | Paradigm System | Proprio, Inc. | OLO | Class II | 2025-06-04 |
| K243205 | EVAC | Phasor Health, LLC | JXG | Class II | 2025-06-03 |
| K243856 | TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026) | Shenzhen Astec Technology Co., Ltd. | NUH | Class II | 2025-05-29 |
| K251315 | Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II | Remex Medical Corp. | OLO | Class II | 2025-05-29 |
| K242841 | Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) | ABBOTT MEDICAL | GXI | Class II | 2025-05-27 |
| K250239 | NeuroMatch | LVIS Corporation | OLX | Class II | 2025-05-23 |
| K250361 | SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1 | Geske Beauty Tech GmbH | NFO | Class II | 2025-05-23 |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac S | Brain Navi Biotechnology Co., Ltd. | HAW | Class II | 2025-05-23 |
| K243429 | HJY VisualNext 3D Endoscopic Vision System | Hjy Smart Medical Device Co., Ltd. | GWG | Class II | 2025-05-21 |
| K250086 | OTS Hip | Ortoma AB | OLO | Class II | 2025-05-16 |
| K242569 | Mixed Reality Spine Navigation | Brainlab AG | SBF | Class II | 2025-05-16 |
| K250213 | OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) | Stryker Instruments | GXI | Class II | 2025-05-15 |
| K250420 | Helios Dura Regeneration Matrix | Helios Biomedical, Inc. | GXQ | Class II | 2025-05-14 |
| K250405 | Nerivio; Nerivio Infinity | Theranica Bio-Electronics, Ltd. | QGT | Class II | 2025-05-14 |
| K250360 | TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026) | Shenzhen Jiantuo Electronics Co., Ltd. | NUH | Class II | 2025-05-11 |
| K250053 | TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B) | Shenzhen Jiantuo Electronics Co., Ltd. | NUH | Class II | 2025-05-09 |
6,130 clearances in the Neurology panel. Data: openFDA.