Review Panel
Neurology FDA 510(k) Clearances & Devices
- Cleared Devices
- 6,130
- Product Codes (page)
- 43
- Latest Decision
- 2026-04-16
Clearances · page 2 of 62
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K253907 | Disposable Radiofrequency Cannula | ABBOTT MEDICAL | GXI | Class II | 2026-04-16 |
| K260011 | Foundation Surgical Navigated Lateral Disc Prep Instruments | Foundation Surgical Group, Inc. | OLO | Class II | 2026-04-16 |
| K240974 | SPRINT PNS System | Spr Therapeutics, Inc. | SCN | Class II | 2026-04-14 |
| K252241 | Pressio 3 Multi-parameter Neuromonitoring System | Sophysa | GWM | Class II | 2026-04-10 |
| K254004 | VRNT | Cognifisense, Inc. | QRA | Class II | 2026-04-10 |
| K260245 | SILKBridge | KLISBio S.r.l. | JXI | Class II | 2026-04-09 |
| K252251 | EASYMADE-TI | CG Bio Co., Ltd. | GXN | Class II | 2026-04-09 |
| K254158 | SPINEART Navigation Instrument System | Spineart SA | OLO | Class II | 2026-04-09 |
| K260363 | Ceribell Brain Monitor Headband | Ceribell, Inc. | GXY | Class II | 2026-04-03 |
| DEN240071 | neuropacs | Automated Imaging Diagnostics, LLC | SHO | Class II | 2026-04-03 |
| K260240 | SYMPHONY Navigation Ready Instruments | Medos International SARL | OLO | Class II | 2026-03-27 |
| K253627 | Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2) | Surgify Medical OY | HBE | Class II | 2026-03-26 |
| K260601 | REAL INTELLIGENCE CORI | Blue Belt Technologies, Inc. | OLO | Class II | 2026-03-26 |
| K253379 | Stealth AXiS Cranial clinical application | Medtronic Navigation, Inc. | HAW | Class II | 2026-03-26 |
| K252037 | CUVIS-joint (CJ150) | Curexo, Inc. | OLO | Class II | 2026-03-25 |
| K252358 | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) | Nexstim Oyj | OBP | Class II | 2026-03-20 |
| K253604 | TiLink-L Navigation Instruments | SurGenTec, LLC | OLO | Class II | 2026-03-20 |
| K253098 | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) | Nexstim Oyj | OBP | Class II | 2026-03-20 |
| K260585 | Noxturnal Web | Nox Medical Ehf | OLV | Class II | 2026-03-20 |
| K253444 | EUROPA Posterior Cervical Fusion Navigated Instruments | MiRus, LLC | OLO | Class II | 2026-03-18 |
| K260546 | Q Pedicle Instruments | K2m, Inc. | OLO | Class II | 2026-03-17 |
| K253587 | Cala kIQ Plus | Cala Health, Inc. | QBC | Class II | 2026-03-17 |
| K253395 | Stealth AXiS ENT clinical application | Medtronic Navigation, Inc. | PGW | Class II | 2026-03-16 |
| K253447 | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) | Orthocon, Inc. | GXR | Class II | 2026-03-16 |
| K260455 | New Wave System | Zeto, Inc. | GWQ | Class II | 2026-03-13 |
| K253732 | Permatage Flowable, Settable Bone Paste | Orthocon, Inc. | GXP | Class II | 2026-03-13 |
| K260453 | Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) | Bionit Labs Srl | GXY | Class II | 2026-03-12 |
| K253668 | Onera SleepMap (SLEEPMAP) | Onera B.V. | OLZ | Class II | 2026-03-08 |
| K253772 | Velocity Alpha MR High Speed Surgical Drill System | Adeor Medical AG | HBB | Class II | 2026-03-06 |
| K253442 | EarliPoint Assessment | Earlitec Diagnostics | QPF | Class II | 2026-03-05 |
| K253896 | TENS/EMS device (GUSE01) | Globalcare Medical Technology Co., Ltd. | NUH | Class II | 2026-03-04 |
| K260010 | TMINI® Miniature Robotic System | THINK Surgical, Inc. | OLO | Class II | 2026-03-03 |
| K260222 | Mako Total Knee Application | Mako Surgical Corp. | OLO | Class II | 2026-02-25 |
| K251653 | SPRY TMS Therapy System (0550) | Soterix Medical, Inc. | OBP | Class II | 2026-02-20 |
| K252989 | POINT Kinguide Agile Hybrid Navigation System; DRF Accessories Set | Point Robotics MedTech, Inc. | OLO | Class II | 2026-02-20 |
| K254148 | VERTICALE GPS Instruments | Silony Medical GmbH | OLO | Class II | 2026-02-19 |
| K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) | Alphatec Spine, Inc. | OLO | Class II | 2026-02-19 |
| K253623 | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor | Stryker Leibinger GmbH & Co KG | OLO | Class II | 2026-02-19 |
| K251802 | STAR RF Ablation System | Merit Medical Systems, Inc. | GXI | Class II | 2026-02-13 |
| K252565 | PreOp v3 | Clouds of Care | OLX | Class II | 2026-02-13 |
| K253381 | Stealth AXiS Surgical System with Stealth AXiS Spine clinical application | Medtronic Navigation, Inc. | OLO | Class II | 2026-02-12 |
| K254033 | Ceribell Instant EEG Headset | Ceribell, Inc. | GXY | Class II | 2026-02-09 |
| K252871 | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories | Stryker Leibinger GmbH & Co KG | OLO | Class II | 2026-02-06 |
| K252058 | ROSA Knee System with UltraSound Imaging Platform (USIP) | Balmoral Medical, LLC | OLO | Class II | 2026-02-06 |
| K252873 | Q Interbody Instruments | K2m, Inc. | OLO | Class II | 2026-02-06 |
| K251517 | Encora X1 | Encora, Inc. | QBC | Class II | 2026-02-05 |
| K252087 | Navigation Module of the Cortium® System | Ulrich Medical USA, Inc. | OLO | Class II | 2026-02-03 |
| K254221 | Optima Coil System (OptiOne Coil System) | Balt USA, LLC | HCG | Class II | 2026-01-27 |
| K252755 | POINT Kinguide Agile Robotic Arm Surgical Stereotactic System | Point Robotics MedTech, Inc. | OLO | Class II | 2026-01-23 |
| K251286 | Affirm 400 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | QFX | Class II | 2026-01-21 |
| K253363 | NeuroSpan Bridge | Auxilium Biotechnologies, Inc. | JXI | Class II | 2026-01-17 |
| K252767 | actiTENS mini | Sublimed | GZJ | Class II | 2026-01-16 |
| K252958 | METICULY Patient-specific titanium mesh implant | Meticuly Co., Ltd. | GXN | Class II | 2026-01-14 |
| K252962 | DYNAMIS Navigation System | Promethean Restorative, LLC | OLO | Class II | 2026-01-12 |
| K252842 | SafeOp 3: Neural Informatix System | Alphatec Spine, Inc. | GWF | Class II | 2026-01-11 |
| K252847 | NextAR Hip Platform | Medacta International S.A. | SBF | Class II | 2026-01-09 |
| K253308 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models | Materialise NV | PPT | Class II | 2026-01-07 |
| K253854 | MONTAGE XT Cranial Cement | Orthocon, Inc. | GXP | Class II | 2026-01-02 |
| K253305 | TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) | Shenzhen Jiantuo Electronics Co., Ltd. | NUH | Class II | 2025-12-31 |
| K252951 | Genesis Sleep | Neurofield, Inc. | QJQ | Class II | 2025-12-31 |
| K252146 | Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) | Shenzhen Siken 3D Technology Development Co., Ltd. | NFO | Class II | 2025-12-23 |
| K253740 | TENS&EMS (HZ9151B, HZ9151C, HZ9151D) | Hong Qiangxing (Shenzhen) Electronics Limited | NUH | Class II | 2025-12-23 |
| K251958 | VEINOPLUS Back | Dynapulse Medical | NUH | Class II | 2025-12-23 |
| K252187 | Aura Glide (FC40) | Aura Medical, LLC | NFO | Class II | 2025-12-23 |
| K252981 | EmbraceMini | Empatica S.r.l. | LEL | Class II | 2025-12-22 |
| K253661 | TMINI Miniature Robotic System | THINK Surgical, Inc. | OLO | Class II | 2025-12-22 |
| K252950 | Paradigm System | Proprio, Inc. | OLO | Class II | 2025-12-15 |
| K250851 | Hypnos (369054-200) | Cadwell Industries, Inc. | OLZ | Class II | 2025-12-14 |
| K252694 | Target Detachable Coil | Stryker Neurovascular | HCG | Class II | 2025-12-11 |
| K251598 | Intellidrop | Brainspace, Inc. | JXG | Class II | 2025-12-10 |
| K251936 | Ceribell Delirium Monitor System | Ceribell, Inc. | NCG | Class II | 2025-12-08 |
| K252841 | REAL INTELLIGENCE CORI XT (CORI XT) | Blue Belt Technologies, Inc. | OLO | Class II | 2025-12-05 |
| K251943 | Spineology Navigation Instruments | Spineology, Inc. | OLO | Class II | 2025-12-04 |
| K251881 | HippoMind (v1.0) | Hippoclinic | OLT | Class II | 2025-12-03 |
| K250636 | Sophy Mini Monopressure Valve (SM1) | Sophysa | JXG | Class II | 2025-11-28 |
| K251550 | NX01 (NX01) | Naox Technologies Sas | OMC | Class II | 2025-11-25 |
| K252688 | Transcutaneous Electrical Nerve Stimulator (RJTENS-2) | Bozhou Rongjian Medical Appliance Co., Ltd. | NUH | Class II | 2025-11-24 |
| K251506 | Nelli (Version 7.11) | Neuro Event Labs OY | POS | Class II | 2025-11-21 |
| K252070 | Ceribell Infant Seizure Detection Software | Ceribell, Inc. | OMB | Class II | 2025-11-21 |
| K252696 | LEGACY | Phasor Health, LLC | HBG | Class II | 2025-11-21 |
| K251856 | Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 | Everyway Medical Instruments Co.,Ltd | NUH | Class II | 2025-11-21 |
| K251191 | Collagen Dura Regeneration Membrane - Repair | Collagen Matrix, Inc. | GXQ | Class II | 2025-11-18 |
| K252330 | DeepRESP | Nox Medical Ehf | OLZ | Class II | 2025-11-17 |
| DEN250015 | Neurolyser XR (NXR100) | Fusmobile, Inc. | SGN | Class II | 2025-11-14 |
| K251314 | Rosa® Knee System | Orthosoft Inc. (d/b/a) Zimmer CAS | OLO | Class II | 2025-11-13 |
| K243715 | Synthes Patient Specific Implants | Synthes GmbH | GXN | Class II | 2025-11-12 |
| K252573 | KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE | KLS-Martin L.P. | GXN | Class II | 2025-11-10 |
| K251391 | BrainsWay Deep TMS System | Brainsway , Ltd. | OBP | Class II | 2025-11-07 |
| K243131 | Triathlon Pro | Sigma Biomedical | NUH | Class II | 2025-11-07 |
| K250423 | mb-FIX Cranial Stabilization Systems | Medical Bees GmbH | HBL | Class II | 2025-11-06 |
| K250815 | Hubly Drill (H100) | Hubly, Inc. | HBE | Class II | 2025-11-06 |
| K250363 | Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept | Beijing Sinovation Medical Technology Co., Ltd. | GZL | Class II | 2025-11-05 |
| K252514 | EVAC-MRI | Phasor Health, LLC | JXG | Class II | 2025-11-05 |
| K250599 | ExcelsiusGPS Instruments | Globus Medical, Inc. | OLO | Class II | 2025-11-05 |
| K252088 | Firebird SI Navigation System | Orthofix US, LLC | OLO | Class II | 2025-10-31 |
| K252160 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | Persyst Development, LLC | OMB | Class II | 2025-10-31 |
| K252060 | GREEN | Phasor Health, LLC | HBE | Class II | 2025-10-31 |
| K251381 | Ceribell Instant EEG Headcap (Small: C251, Medium: C252) | Ceribell, Inc. | GXY | Class II | 2025-10-31 |
| K250618 | Medi Lift Essential Eye Mask | Ya-Man, Ltd. | NFO | Class II | 2025-10-29 |
| K252742 | Navigated Instruments | Tyber Medical, LLC | OLO | Class II | 2025-10-28 |
6,130 clearances in the Neurology panel. Data: openFDA.