| 2026-06-27 | K253390 | SOMNUM (SOMNUM) | Honeynaps Co., Ltd. | Neurology |
| 2026-06-03 | K260402 | MeRT System | Wave Neuroscience | Neurology |
| 2026-04-22 | K253256 | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) | Otto Bock Healthcare Products GmbH | Neurology |
| 2026-03-26 | K253379 | Stealth AXiS Cranial clinical application | Medtronic Navigation, Inc. | Neurology |
| 2026-03-08 | K253668 | Onera SleepMap (SLEEPMAP) | Onera B.V. | Neurology |
| 2026-03-05 | K253442 | EarliPoint Assessment | Earlitec Diagnostics | Neurology |
| 2026-02-12 | K253381 | Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application | Medtronic Navigation, Inc. | Neurology |
| 2026-01-11 | K252842 | SafeOp 3: Neural Informatix System | Alphatec Spine, Inc. | Neurology |
| 2025-12-08 | K251936 | Ceribell Delirium Monitor System | Ceribell, Inc. | Neurology |
| 2025-11-21 | K251506 | Nelli (Version 7.11) | Neuro Event Labs OY | Neurology |
| 2025-11-17 | K252330 | DeepRESP | Nox Medical Ehf | Neurology |
| 2025-10-03 | K251639 | xvision Spine system | Augmedics, Ltd. | Neurology |
| 2025-09-29 | K252054 | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | Neurology |
| 2025-09-11 | K251316 | Mazor X System / Mazor X Stealth Edition | Mazor Robotics Ltd. | Neurology |
| 2025-07-01 | K250096 | Felix NeuroAI System | Fasikl Incorporated | Neurology |
| 2025-06-20 | K250877 | TMINI Miniature Robotic System | THINK Surgical, Inc. | Neurology |
| 2025-06-19 | K250515 | EpiMonitor | Empatica Srl | Neurology |
| 2025-05-16 | K250086 | OTS Hip | Ortoma AB | Neurology |
| 2025-04-11 | K243558 | Canvas Dx | Cognoa, Inc. | Neurology |
| 2025-04-09 | K243743 | autoSCORE (V 2.0.0) | Holberg EEG AS | Neurology |
| 2025-03-26 | K243891 | EarliPoint System | EarliTec Diagnostics | Neurology |
| 2025-03-14 | K241960 | DeepRESP | Nox Medical ehf | Neurology |
| 2025-03-13 | K250255 | xvision Spine system | Augmedics Ltd. | Neurology |
| 2025-02-20 | K242447 | Falcon HST | Compumedics Limited | Neurology |
| 2025-01-24 | K243657 | ClearPoint System (Software Version 3.0) | ClearPoint Neuro, Inc. | Neurology |
| 2025-01-13 | K243950 | ARVIS® Shoulder | Kico Knee Innovation Company Pty Ltd | Neurology |
| 2025-01-06 | K243481 | TMINI Miniature Robotic System | THINK Surgical, Inc. | Neurology |
| 2024-12-27 | K242480 | FLASH EVD System (10-0002) | 7D Surgical ULC | Neurology |
| 2024-11-26 | K241390 | NeuroMatch | LVIS Corporation | Neurology |
| 2024-11-22 | K242094 | Dreem 3S | Beacon Biosignals, Inc. | Neurology |
| 2024-10-17 | K240408 | REMI-AI Rapid Detection Module (REMI-AI RDM) | Epitel, Inc | Neurology |
| 2024-10-16 | K241481 | xvision Spine System | Augmedics Ltd. | Neurology |
| 2024-09-27 | K240993 | encevis (2.1) | AIT Austrian Institute of Technology GmbH | Neurology |
| 2024-04-29 | K240062 | ARVIS® Shoulder | Insight Medical Systems, Inc. | Neurology |
| 2024-04-03 | K233618 | Oxevision Sleep Device | Oxehealth Limited | Neurology |
| 2024-03-20 | K234047 | Automatic Registration | Brainlab AG | Neurology |
| 2024-03-11 | K232140 | OTS Hip | Ortoma AB | Neurology |
| 2024-03-08 | K233438 | SleepStageML | Beacon Biosignals, Inc. | Neurology |
| 2024-02-15 | K232915 | EpiMonitor | Empatica Srl | Neurology |
| 2024-01-11 | DEN220066 | BrainSee | Darmiyan, Inc. | Neurology |
| 2024-01-07 | K231068 | autoSCORE | Holberg EEG AS | Neurology |
| 2024-01-03 | K231779 | REMI AI Discrete Detection Module | Epitel, Inc. | Neurology |
| 2023-11-27 | K233243 | ClearPoint System (Software Version 2.2) | ClearPoint Neuro Inc. | Neurology |
| 2023-09-09 | K223864 | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial | Brainlab AG | Neurology |
| 2023-08-18 | K223539 | Dreem 3S | Beacon Biosignals, Inc. | Neurology |
| 2023-08-02 | K223553 | Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine | Brainlab AG | Neurology |
| 2023-07-21 | K223288 | Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI | Brainlab AG | Neurology |
| 2023-06-29 | K230337 | EarliPoint | EarliTec Diagnostics, Inc | Neurology |
| 2023-05-23 | K223504 | Ceribell Status Epilepticus Monitor | Ceribell, Inc. | Neurology |
| 2023-04-27 | K223734 | ENT EM | Brainlab AG | Neurology |
| 2023-04-19 | K223552 | Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial | Brainlab AG | Neurology |
| 2023-03-17 | K221772 | NeuroRPM | New Touch Digital Inc. | Neurology |
| 2023-01-11 | K223738 | Alpha Control Liner System (ACLS) | Coapt | Neurology |
| 2022-09-21 | K221179 | SomnoMetry | Neumetry Medical Inc | Neurology |
| 2022-06-08 | K213882 | EarliPoint System | EarliTec Diagnostics, Inc. | Neurology |
| 2021-10-02 | K202927 | EYE-SYNC | SyncThink, Inc. | Neurology |
| 2021-06-16 | K210034 | EnsoSleep | EnsoData, Inc. | Neurology |
| 2021-06-02 | DEN200069 | Cognoa ASD Diagnosis Aid | Cognoa, Inc. | Neurology |
| 2020-09-06 | K201841 | EyeBOX | Oculogica, Inc. | Neurology |
| 2019-11-27 | K192945 | 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application | 7D Surgical Inc. | Neurology |
| 2019-09-11 | K190815 | BrainScope TBI | BrainScope Company, Inc. | Neurology |
| 2019-09-04 | K191179 | Myo Plus | Otto Bock Healthcare Products GmbH | Neurology |
| 2019-07-31 | K191183 | EyeBOX | Oculogica, Inc. | Neurology |
| 2019-05-24 | K191083 | COMPLETE CONTROL System Gen2 | Coapt, LLC | Neurology |
| 2018-12-28 | DEN170091 | EyeBOX | Oculogica, Inc. | Neurology |
| 2018-12-20 | K181861 | Embrace | Empatica Srl | Neurology |
| 2018-11-29 | K182181 | Persyst 14 EEG Review and Analysis Software | Persyst Development Corporation | Neurology |
| 2018-10-05 | K182112 | Sense System with IBT Electrodes | Infinite Biomedical Technologies, LLC | Neurology |
| 2018-09-28 | K181771 | RightEye Vision System | RightEye, LLC | Neurology |
| 2018-06-29 | K180038 | NuVasive Pulse System | NuVasive, Incorporated | Neurology |
| 2016-09-22 | K161068 | Ahead 300 | BRAINSCOPE COMPANY INC | Neurology |
| 2015-05-15 | K143643 | Brainscope Ahead 200 | BRAINSCOPE COMPANY, INC. | Neurology |
| 2014-11-17 | DEN140025 | BrainScope Ahead 100 | BRAINSCOPE COMPANY, INC | Neurology |