Review Panel
Neurology FDA 510(k) Clearances & Devices
- Cleared Devices
- 6,130
- Product Codes (page)
- 46
- Latest Decision
- 2026-10-02
Clearances · page 1 of 62
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K254030 | cCeLL405 | VPIX Medical, Inc. | QFX | Class II | 2026-10-02 |
| K260064 | Neurora | Argus Cognitive, Inc. | QPF | Class II | 2026-10-02 |
| K260044 | Ventricular Catheters, Thomale Catheter | Aesculap, Inc. | JXG | Class II | 2026-10-02 |
| K262257 | Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine | Brainlab SE | OLO | Class II | 2026-09-30 |
| K263010 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | inomed Medizintechnik GmbH | GWF | Class II | 2026-09-24 |
| K252995 | Durashield Device Kit | SurGenTec, LLC | GZT | Class II | 2026-09-17 |
| K261712 | Ceribell EEG Analysis Software | Ceribell, Inc. | OLT | 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 |
| K260446 | Tontarra Punches and Rongeurs | Tontarra Medizintechnik GmbH | HAE | Class II | 2026-09-15 |
| K262874 | CraniUS Plate | CraniUS, LLC | GWO | Class II | 2026-09-11 |
| K262861 | PureLift Pro Max | Xtreem Pulse, LLC | NFO | Class II | 2026-09-11 |
| K254177 | Disposable Sterile Skull Drill (LZ) | Guizhou Zirui Technology Co., Ltd. | HBF | Class II | 2026-09-11 |
| K254174 | Surgical Power System | Guizhou Zirui Technology Co., Ltd. | HBC | Class II | 2026-09-11 |
| K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. | HAW | Class II | 2026-09-10 |
| 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 |
| K260396 | KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A) | Fidelity BioPharma Co. | OBP | Class II | 2026-09-06 |
| 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 |
| K260387 | SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003) | Hironic Co., Ltd. | NFO | Class II | 2026-08-31 |
| K262654 | Dexus Prosthetic System (MSL2, MSR2) | Zhejiang Qiangnao Technology Co.,Ltd | GXY | Class II | 2026-08-27 |
| K253877 | StimTrial Neuromodulation System | Bioventus, LLC | GZF | Class II | 2026-08-26 |
| K261747 | Report Studio | Beacon Biosignals, Inc. | OLV | Class II | 2026-08-25 |
| K260691 | BTL-699 | BTL Industries, Inc. | OBP | Class II | 2026-08-23 |
| DEN250026 | Avulux | Matap Ii, LLC | QEO | Class I | 2026-08-21 |
| K262515 | Kneu Platform (V2) | Kneu Health Digital , Ltd. | GYD | Class II | 2026-08-20 |
| K262506 | Remex Spine Surgery Navigation - Universal Instruments | Remex Medical Corp. | OLO | Class II | 2026-08-20 |
| K254213 | Pascall Sensor Unit (PSU1) | Pascall Systems, Inc. | OLT | Class II | 2026-08-19 |
| K260563 | CN-Suite | FIND Surgical Sciences Inc. D/B/A FIND Neuro | OLX | Class II | 2026-08-16 |
| K261228 | QuickVision Ultimate rTMS | Brain Ultimate, Inc. | OBP | 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 |
| 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 |
| K260907 | BIS Advance pEEG Module | Covidien LP | OLW | Class II | 2026-08-13 |
| K261932 | Leksell® Vantage Stereotactic System | Elekta Solutions AB | HAW | Class II | 2026-08-05 |
| K261854 | xvision Spine system | Augmedics, Ltd. | SBF | Class II | 2026-07-31 |
| K262253 | Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) | Orthalign, Inc. | ONN | Class II | 2026-07-31 |
| 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 |
| K260566 | SMARTVERTIGO Vestibular Assessment System | VertigoDx, Inc. | GWN | Class II | 2026-07-30 |
| K254038 | Motivista (CT-155) | Click Therapeutics, Inc. | SAP | Class II | 2026-07-30 |
| K251959 | TnR Cranial Implant | T&R BIOFAB CO., Ltd. | GXP | Class II | 2026-07-30 |
| K261205 | SPINEART Navigation Instrument System | Spineart SA | OLO | Class II | 2026-07-29 |
| K261058 | CraniUS Plate | CraniUS, LLC | GWO | Class II | 2026-07-29 |
| K262121 | Ion-L Navigated Instruments | SurGenTec, LLC | OLO | Class II | 2026-07-24 |
| K261024 | TMINI Miniature Robotic System | THINK Surgical, Inc. | OLO | Class II | 2026-07-24 |
| K253932 | FACEGYM Pro Device (HD-109) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | NFO | Class II | 2026-07-23 |
| K261113 | Op.n Spine Navigation and Robotic Guidance | Ecential Robotics | OLO | Class II | 2026-07-22 |
| K253814 | Raney Clips Kit | Beijing Honghugaoxiang Science and Technology Development CO | HBO | Class II | 2026-07-21 |
| 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 |
| K260880 | SedLine Sedation Monitor | Masimo Corporation | OLW | Class II | 2026-07-10 |
| K261471 | Zeta TMS Navigation System | Zeta Surgical, Inc. | QFF | Class II | 2026-07-09 |
| K261852 | OTS Hip | Ortoma AB | OLO | Class II | 2026-07-01 |
| K261101 | Ceribell Monitor | Ceribell, Inc. | OMC | Class II | 2026-06-30 |
| K253767 | UB ERP System | Universal Brain | OLT | Class II | 2026-06-30 |
| K253390 | SOMNUM (SOMNUM) | Honeynaps Co., Ltd. | OLZ | Class II | 2026-06-27 |
| K253301 | BraiN20® (BraiN20) | Time IS Brain, S.L. | GWF | Class II | 2026-06-27 |
| K253921 | VERTICALE® Navigation Instruments | Silony Medical GmbH | OLO | 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 |
| K260412 | TENS 7000 Rechargeable 4 Channel (TENS 7000H) | Shenzhen Dongdixin Technology Co., Ltd. | NUH | Class II | 2026-06-26 |
| K260480 | VELYS Robotic-Assisted Solution | Depuy Ireland UC | OLO | Class II | 2026-06-25 |
| 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 |
| K261772 | Target Xtra Detachable Coil | Stryker Neurovscular | HCG | Class II | 2026-06-24 |
| K260998 | Ceribell Neurology Review Software | Ceribell, Inc. | OMB | Class II | 2026-06-24 |
| K261004 | Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) | Integra Lifesciences Production Corporation | JXG | Class II | 2026-06-23 |
| K260369 | Dynamis Robotic Surgical System | LEM Surgical AG | OLO | Class II | 2026-06-20 |
| K253116 | 3D MAC Titanium Cranial Plate (TCP) System | The Surgeon General, Department of the Army (TSG-DA) | GXN | Class II | 2026-06-18 |
| K261665 | CORUS Navigation System-GN | Providence Medical Technology, Inc. | OLO | Class II | 2026-06-18 |
| K253055 | Sine Monitoring Parkinsons Disease Tremor Dyskinesia Apple Watch (SMPDTDAW) | Nordic Kinetics AB | GYD | Class II | 2026-06-17 |
| K260425 | TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) | Hivox Biotek, Inc. | NUH | Class II | 2026-06-16 |
| K261265 | Permatage XT Settable Bone Putty | Orthocon, Inc. | GXP | Class II | 2026-06-15 |
| K261604 | Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) | Neuroelectrics Barcelona S.L.U. | GWQ | Class II | 2026-06-13 |
| K253015 | Cognitive Function Neuroimaging (cfNI) Software (1.0.0) | VoxNeuro, Inc. | OLU | Class II | 2026-06-12 |
| K253607 | UNEEG EpiSight System | Uneeg Medical A/S | SEM | Class II | 2026-06-11 |
| K254086 | EyeBOX SNAP | Oculogica, Inc. | QEA | Class II | 2026-06-05 |
| K253602 | Precision S 4K Sinuscope | Stryker Endoscopy | GWG | Class II | 2026-06-04 |
| K260179 | VITA Multi-Function Head Brush (TB-2343F, TB-2442F) | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | NFO | Class II | 2026-06-03 |
| K260402 | MeRT System | Wave Neuroscience | SIG | Class II | 2026-06-03 |
| K261522 | BioWave BioWraps | Biowave Corporation | GXY | Class II | 2026-06-03 |
| K253507 | Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee | Orthalign, Inc. | ONN | Class II | 2026-06-02 |
| K261540 | Cube 4D Navigation System, VirtuEye Pro | Fiagon GmbH | PGW | Class II | 2026-06-02 |
| K260571 | SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments | Life Spine, Inc. | OLO | Class II | 2026-06-02 |
| K261060 | Navigated LLIF Impactable Tracker | Tyber Medical, LLC | OLO | Class II | 2026-05-29 |
| K260895 | Ulike Clear Zero (YC10 BU) | Guangxi Ulike Medical Technology Co., Ltd. | NFO | Class II | 2026-05-28 |
| K252712 | STIMPOD NMS460 Nerve Stimulator | Algiamed Technologies USA, Inc. | GZJ | Class II | 2026-05-28 |
| K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | Medos International SARL | OLO | Class II | 2026-05-26 |
| K260560 | Apollo TMS Therapy System;Apollo light TMS Therapy System | Mag & More GmbH | OBP | Class II | 2026-05-22 |
| K260189 | MagVenture Accelerated TMS (aTMS) Therapy System | Tonica Elektronik A/S | OBP | Class II | 2026-05-22 |
| K260329 | Ion-C Navigation Instruments | SurGenTec, LLC | OLO | Class II | 2026-05-22 |
| K260582 | ROSA® Shoulder System | Orthosoft Inc. (d/b/a) Zimmer CAS | OLO | Class II | 2026-05-21 |
| K260351 | Numen Helia Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | HCG | Class II | 2026-05-20 |
| K253061 | Portable Neuromodulation Stimulator (PoNS) | Helius Medical, Inc. | QCF | Class II | 2026-05-13 |
| K252880 | Pytheas Your Guided Trajectory | Pytheas Navigation Sas | OLO | Class II | 2026-05-11 |
| DEN250013 | Modius Spero | Neurovalens Limited | SHX | Class II | 2026-05-08 |
| K252621 | DeepSkin (DEP100) | El Global Trade, Ltd. | NFO | Class II | 2026-05-08 |
| K253237 | Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) | Elde Medikal Sanayi ve Ticaret Anonim Sirketi | GXY | Class II | 2026-05-08 |
| K253679 | Hydro Irrigation System | Stryker Instruments | GWG | Class II | 2026-05-08 |
| K254183 | MR Conditional Cup Electrodes | Technomed Europe | GXY | Class II | 2026-05-07 |
| K253663 | Zeta Navigation System | Zeta Surgical, Inc. | HAW | Class II | 2026-05-01 |
| K252439 | Tutamen Self Adhesive Electrodes | Dongguan Tutamen Metalwork Co., Ltd. | GXY | Class II | 2026-05-01 |
| K253805 | Knee+ | Pixee Medical S.A.S. | SBF | Class II | 2026-04-24 |
| K253256 | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) | Otto Bock Healthcare Products GmbH | GXY | Class II | 2026-04-22 |
| K253970 | Wovyn Depth Electrode | Sensomedical Labs, Ltd. | GZL | Class II | 2026-04-17 |
| K254216 | Enso for Migraine | Hinge Health, Inc. | PCC | Class II | 2026-04-16 |
6,130 clearances in the Neurology panel. Data: openFDA.