Review Panel
Neurology FDA 510(k) Clearances & Devices
- Cleared Devices
- 6,130
- Product Codes (page)
- 45
- Latest Decision
- 2025-05-08
Clearances · page 4 of 62
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K243419 | Altus Spine Navigation System | Altus Partners, LLC | OLO | Class II | 2025-05-08 |
| K243828 | CIONIC NEURAL SLEEVE (NS-200) | Cionic, Inc. | GZI | Class II | 2025-05-02 |
| K250153 | Neu Platform | Neuhealth Digital , Ltd. | GYD | Class II | 2025-04-25 |
| K250608 | Mako Total Knee Application (3.0); Hybrid Tip Pointer | Mako Surgical Corp. | OLO | Class II | 2025-04-25 |
| K233337 | Freespira Breathing System | Freespira, Inc. | SEN | Class II | 2025-04-24 |
| K243326 | Dynamis Robotic Surgical System | LEM Surgical AG | OLO | Class II | 2025-04-23 |
| K243460 | Ultimate rTMS | Brain Ultimate, Inc. | OBP | Class II | 2025-04-17 |
| K243459 | Ultimate rTMS for OCD (M-series) | Brain Ultimate, Inc. | QCI | Class II | 2025-04-17 |
| DEN240062 | Minder System | Epi-Minder Pty, Ltd. | SEM | Class II | 2025-04-17 |
| K242806 | Medyssey Navigation System | Medyssey Co, Ltd. | OLO | Class II | 2025-04-16 |
| K243513 | DCM (PW-DCM) | Pneumowave, Ltd. | LEL | Class II | 2025-04-16 |
| K250094 | Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014) | Neuralynx, Inc. | GYC | Class II | 2025-04-14 |
| DEN240064 | CT-132 | Click Therapeutics, Inc. | SEE | Class II | 2025-04-11 |
| K243558 | Canvas Dx | Cognoa, Inc. | QPF | Class II | 2025-04-11 |
| K250371 | cryoICE cryoXT cryoablation probe (cryoXT) | AtriCure, Inc. | GXH | Class II | 2025-04-10 |
| K250058 | NEAT 001 | Brain Electrophysiology Laboratory Company, LLC | OLZ | Class II | 2025-04-10 |
| K241589 | Ceribell Seizure Detection Software | Ceribell, Inc. | OMB | Class II | 2025-04-09 |
| K243613 | Patch-TEA (Model TRI-21) | Transtimulation Research, Inc. | NUH | Class II | 2025-04-09 |
| K243743 | autoSCORE (V 2.0.0) | Holberg Eeg AS | OMB | Class II | 2025-04-09 |
| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) | Integra LifeSciences Corporation | GWG | Class II | 2025-04-09 |
| K243749 | Jmoon Conductive Gel | Shenzhen Ulike Smart Electronics Co., Ltd. | GYB | Class II | 2025-04-08 |
| K250033 | Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) | Guangzhou Pinzhi Medical Technology Co., Ltd. | NUH | Class II | 2025-04-07 |
| K242116 | EyeBOX EBX-4.1 | Oculogica, Inc. | QEA | Class II | 2025-04-04 |
| K243514 | Salvo® Robotic Navigation Instruments | Spine Wave, Inc. | OLO | Class II | 2025-04-03 |
| K243659 | FLASH Facet Fusion Instruments, IsoTis® Facet Fusion Instruments | SeaSpine Orthopedics Corporation | OLO | Class II | 2025-04-02 |
| K242460 | Progenix Select Stim | Progenix, LLC | NUH | Class II | 2025-04-02 |
| K242113 | Nerve Wrap (07-DW-001-TAB) | Biocircuit Technologies, Inc. | JXI | Class II | 2025-04-02 |
| K243889 | Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm) | Orthocell, Ltd. | JXI | Class II | 2025-04-02 |
| K243072 | Préime DermaFacial (MicroT) | EMA Aesthetics , Ltd. | NFO | Class II | 2025-04-01 |
| K250601 | Neuro Omega System; NeuroSmart System | Alpha Omega Engineering , Ltd. | GZL | Class II | 2025-03-30 |
| K242618 | Layer 7-T | Precision Neuroscience, Corp. | GYC | Class II | 2025-03-30 |
| K243520 | Bullsai Confirm | Turing Medical Technologies, Inc. | QQC | Class II | 2025-03-28 |
| K241785 | StarFormer (M008-3T) | Fotona D.O.O. | QPL | Class II | 2025-03-27 |
| K243426 | Nurochek-Pro System | Headsafe Mfg Pty, Ltd. | PIW | Class II | 2025-03-27 |
| K240189 | NM-01/CPT neurometer (NM-01/CPT) | Mde Orvosbiológiai Kutató, Fejleszto, | JXE | Class II | 2025-03-26 |
| K243891 | EarliPoint System | Earlitec Diagnostics | QPF | Class II | 2025-03-26 |
| K250182 | Innovasis Navigation Instruments | Innovasis, Inc. | OLO | Class II | 2025-03-24 |
| K243185 | REMI Remote EEG Monitoring System | Epitel | OMC | Class II | 2025-03-21 |
| K243958 | Consolidated Operating Room Equipment (CORE) 2 Console | Stryker Instruments | OLO | Class II | 2025-03-21 |
| K243980 | ARVIS Surgical Navigation System | Kico Knee Innovation Company Pty Limited | SBF | Class II | 2025-03-21 |
| K243975 | Knee+ | Pixee Medical | SBF | Class II | 2025-03-20 |
| K243869 | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0) | The Magstim Company Limited | OBP | Class II | 2025-03-17 |
| K244056 | DOC Band 3D | Cranial Technologies, Inc. | OAN | Class II | 2025-03-17 |
| K241960 | DeepRESP | Nox Medical Ehf | OLZ | Class II | 2025-03-14 |
| K242121 | mBôs (Monogram mBôs TKA System) | Monogram Orthopaedics, Inc. | OLO | Class II | 2025-03-14 |
| K243788 | IceCap product line | Bioserenity Medical Devices Group | GXY | Class II | 2025-03-13 |
| K250255 | xvision Spine system | Augmedics, Ltd. | SBF | Class II | 2025-03-13 |
| K250380 | 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 Medical OY | HBE | Class II | 2025-03-13 |
| K243746 | Delphi Amplifier | Quantalx Neroscience | GWL | Class II | 2025-03-12 |
| K250374 | iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R | Stryker Instruments | HBE | Class II | 2025-03-11 |
| K243676 | Duet External Drainage and Monitoring System (EDMS) | Medtronic Neurosurgery | JXG | Class II | 2025-03-10 |
| K242914 | Op.n(TM) Navigation | Ecential Robotics | OLO | Class II | 2025-03-07 |
| K243515 | EpiWatch Monitoring System | Epiwatch, Inc. | POS | Class II | 2025-03-07 |
| K242890 | SPINEART Navigation Instrument System | Spineart SA | OLO | Class II | 2025-03-07 |
| K243587 | PureLift GLOW | Xtreem Pulse, LLC | NFO | Class II | 2025-03-06 |
| K243751 | Mako Total Hip Application 5.0 | Mako Surgical Corp. | OLO | Class II | 2025-03-05 |
| K242676 | pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device | Phenox Limited | POL | Class II | 2025-02-28 |
| K243258 | Paradigm System | Proprio, Inc. | OLO | Class II | 2025-02-21 |
| K242447 | Falcon HST | Compumedics Limited | OLV | Class II | 2025-02-20 |
| K241737 | Sway System Sports Plus | Sway Medical, Inc. | POM | Class II | 2025-02-15 |
| K242198 | ICS Dizcovery (1091) | Natus Medical Denmark Aps | GWN | Class II | 2025-02-14 |
| K243319 | Ampa One System (AMPA-001) | Neuromodulatory Devices & Applications | OBP | Class II | 2025-02-13 |
| K243063 | Myolight Microcurrent Handpiece | Raja Trading Company, Inc. | NFO | Class II | 2025-02-10 |
| K243243 | Delphi MCS Electrode Cap | Quantalx Neuroscience, Ltd. | GXY | Class II | 2025-02-06 |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), Cranial | Claronav | HAW | Class II | 2025-02-05 |
| K243393 | JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP) | Shenzhen Ulike Smart Electronics Co., Ltd. | NFO | Class II | 2025-02-03 |
| K243387 | GYDER® Hip System | Gyder Surgical Pty, Ltd. | OLO | Class II | 2025-01-29 |
| K243698 | Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT | Brainlab AG | HAW | Class II | 2025-01-28 |
| K243657 | ClearPoint System (Software Version 3.0) | ClearPoint Neuro, Inc. | HAW | Class II | 2025-01-24 |
| K241367 | RF Cannula | Shanghai Samedical & Plastic Instruments Co., Ltd. | GXI | Class II | 2025-01-23 |
| K242446 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | Persyst Development Corporation | OMB | Class II | 2025-01-22 |
| K243982 | Nicolet EDX | Natus Neurology Incorporated | GWF | Class II | 2025-01-22 |
| K241333 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. | HAW | Class II | 2025-01-17 |
| DEN230051 | Myocene | Myocene | SDX | Class II | 2025-01-17 |
| K244048 | Medi Lift Mask | Ya-Man, Ltd. | NFO | Class II | 2025-01-16 |
| K243848 | Cala kIQ | Cala Health, Inc. | QBC | Class II | 2025-01-16 |
| K243289 | ADDNOX (BPSPM1) | Nu Eyne Co., Ltd. | QGL | Class II | 2025-01-16 |
| K241512 | Electrode Pad | Shenzhen Deliduo Medical Technology Co.,Ltd | GXY | Class II | 2025-01-15 |
| K243950 | ARVIS® Shoulder | Kico Knee Innovation Company Pty, Ltd. | SBF | Class II | 2025-01-13 |
| K243814 | NuVasive Pulse System | Globus Medical, Inc. | OLO | Class II | 2025-01-10 |
| K243481 | TMINI Miniature Robotic System | THINK Surgical, Inc. | OLO | Class II | 2025-01-06 |
| K242726 | Synapsys VHIT | Inventis S.R.L. | GWN | Class II | 2025-01-03 |
| K242326 | Wave Electrode (AE02-60); Wave Electrode (AE02-50) | Bionit Labs Srl | GXY | Class II | 2025-01-02 |
| K242480 | FLASH EVD System (10-0002) | 7D Surgical ULC | HAW | Class II | 2024-12-27 |
| K243677 | iovera° System | Pacira Biosciences, Inc. | GXH | Class II | 2024-12-26 |
| K243623 | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | SBF | Class II | 2024-12-24 |
| K241288 | Noxturnal Web | Nox Medical Ehf | OLV | Class II | 2024-12-23 |
| K243671 | ExcelsiusGPS® Instruments | Globus Medical, Inc. | OLO | Class II | 2024-12-20 |
| K243430 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | Shenzhen Aozemei Technology Co., Ltd. | NFO | Class II | 2024-12-19 |
| K242954 | Integrity V500 (Integrity, Integrity with VEMP) | Vivosonic, Inc. | GWJ | Class II | 2024-12-19 |
| K242815 | POCKET TENS (EP-300) | Hivox Biotek, Inc. | NUH | Class II | 2024-12-17 |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set | Aesculap, Inc. | JXG | Class II | 2024-12-16 |
| K241160 | CAIs Sensor (CAIs-001) | Brainu Co., Ltd. | GXY | Class II | 2024-12-13 |
| K242532 | BTL-785BNF-E | BTL Industries, Inc. | NFO | Class II | 2024-12-13 |
| K243560 | Remex Spine Surgery Navigation Instrument | Remex Medical Corp. | OLO | Class II | 2024-12-13 |
| K243495 | Natus Ultrapro S100 (982A0594) | Natus Neurology Incorporated | GWF | Class II | 2024-12-12 |
| K242832 | NExT Station; NExT Station Advanced | Eb Neuro S.P.A. | GWL | Class II | 2024-12-12 |
| K241045 | Disposable Subdermal Needle Electrode, Corkscrew | Technomed Europe | GXZ | Class II | 2024-12-11 |
| K240700 | HomeSleepTest (HST, HST REM+) | Somnomedics GmbH | OLV | Class II | 2024-12-08 |
| K243073 | AnyPlus Navigated Instruments System | GS Medical Co., Ltd. | OLO | Class II | 2024-12-06 |
6,130 clearances in the Neurology panel. Data: openFDA.