| DeGen Navigated Instrumentation (K213918) | Degen Medical | 2022-02-09 |
| Primary Relief (K213188) | Dyansys, Inc. | 2022-01-31 |
| SyntheCel Dura Repair (K212943) | Synthes (USA) Products, LLC | 2022-01-28 |
| Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models) (K210360) | Osteonic Co., Ltd. | 2022-01-27 |
| Abbott Medical Grounding Pad, model RF-DGP-IS (K203293) | ABBOTT MEDICAL | 2022-01-21 |
| CoreLink Navigation Instruments (K214059) | Corelink, LLC | 2022-01-19 |
| ARAI Surgical Navigation System (K211254) | Surgalign Spine Technologies | 2022-01-14 |
| iASSIST Knee System (K213033) | Orthosoft D/B/A Zimmer Cas | 2022-01-14 |
| 360CAS (K213380) | Kico Knee Innovation Company Pty Limited | 2022-01-11 |
| ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (K212166) | Inomed Medizintechnik GmbH | 2022-01-07 |
| Vital Navigation System (K213720) | Zimvie (Zimmer Biomet Spine, Inc.) | 2022-01-07 |
| ExactechGPS Total Shoulder Application, Equinoxe Planning Software (K213546) | Blue Ortho | 2022-01-06 |
| Self-adhesive Electrode (K213879) | Bozhou Rongjian Medical Appliance Co., Ltd. | 2022-01-05 |
| Intrelief (K211263) | Easymed Instruments Co., Ltd. | 2021-12-30 |
| Twist Drills (K213208) | Biomet Microfixation | 2021-12-23 |
| Integrity Implants Navigated Instruments (K212088) | Integrity Implants, Inc. | 2021-12-23 |
| Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android) (K212285) | Oriental Inspiration Limited | 2021-12-22 |
| EyeBOX (Model EBX-4) (K212310) | Oculogica, Inc. | 2021-12-22 |
| StealthStation S8 Cranial v2.0 (K212397) | Medtronic Navigation | 2021-12-22 |
| Meticuly Patient-Specific Titanium Mesh Implant (K210099) | Meticuly Co., Ltd. | 2021-12-21 |
| First Relief (K212859) | Dyansys, Inc. | 2021-12-20 |
| Transcutaneous Electrical Nerve Stimulator (K210223) | Top-Rank Health Care Co., Ltd. | 2021-12-15 |
| Aesculap Slim Clip Applier (K211572) | Aesculap, Inc. | 2021-12-13 |
| Heat StimPlus (K212918) | Famidoc Technology Co., Ltd. | 2021-12-13 |
| NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health (K213543) | Neuronetics, Inc. | 2021-12-10 |
| Molecular Flow Simulations (K201435) | Therataxis, LLC | 2021-12-03 |
| Encevis (K211452) | Austrian Institute of Technology GmbH | 2021-12-02 |
| AC Cream - Conductive paste (K212326) | Spes Medica Srl | 2021-12-01 |
| ALTMS Magnetic Stimulation Therapy System (K202537) | Remed Co., Ltd. | 2021-11-26 |
| Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm (K213454) | Medtronic Powered Surgical Solutions | 2021-11-23 |
| Low-frequency Stimulator (Model: AST-645, AST-646) (K212989) | Shenzhen Osto Technology Co., Ltd. | 2021-11-22 |
| DIXI Medical Microdeep Micro-Macro Depth Electrodes (K202087) | Dixi Medical | 2021-11-18 |
| EaseVRx (DEN210014) | Appliedvr, Inc. | 2021-11-16 |
| InZone Detachment System (K212455) | Stryker Neurovascular | 2021-11-16 |
| Wrap Accessory Electrodes (K210383) | Hi-Dow International, Inc. | 2021-11-12 |
| Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System (K210989) | Brainlab AG | 2021-11-12 |
| DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) (K202671) | Guangzhou Xinbo Electronic Co., Ltd. | 2021-11-12 |
| Comby EEG Caps (K211315) | Pamel D.O.O | 2021-11-09 |
| GT5 conductive & abrasive gel (K212787) | Wuhan Greentek Pty , Ltd. | 2021-11-08 |
| Microcurrent device (Model: HBR2-1) (K211055) | Shenzhen DJ Medical Equipment Co., Ltd. | 2021-11-05 |
| NextAR™ Spine Platform (K210859) | Medacta International S.A. | 2021-11-05 |
| Drug Relief v1 (K211971) | Dyansys, Inc. | 2021-11-05 |
| MStim Drop Model: LGT-233 (K202110) | Guangzhou Longest Science & Technology Co., Ltd. | 2021-11-05 |
| REAL INTELLIGENCE CORI (CORI) (K212537) | Blue Belt Technologies, Inc. | 2021-11-03 |
| Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization (K211544) | Brainlab AG | 2021-11-03 |
| P300 Attachment (K202120) | Nakanishi, Inc. | 2021-10-22 |
| HIVOX OTC Electrical Stimulator, FT610-B (K211403) | Hivox Biotek, Inc. | 2021-10-15 |
| ALGO 7i (K211147) | Path Medical GmbH | 2021-10-14 |
| SPRINT PNS System (K211801) | Spr Therapeutics, Inc. | 2021-10-13 |
| CoreLink Navigation Instruments (K212825) | Corelink, LLC | 2021-10-13 |
| B4C System (K201989) | Braincare Desenvolvimento E Inovacao Tecnologica S.A. | 2021-10-08 |
| Adhesive Electrodes (K212191) | Voncare Medical Device Co., Ltd. | 2021-10-06 |
| Cala Trio (K203288) | Cala Health, Inc. | 2021-10-05 |
| Smart Neck Stimulator (K200558) | Guandong Skg Intelligent Technology Co., Ltd. | 2021-10-04 |
| Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) (K201931) | Dixi Medical | 2021-10-02 |
| EYE-SYNC (K202927) | Syncthink, Inc. | 2021-10-02 |
| OSSDSIGN Cranial PSI (K212414) | Ossdsign AB | 2021-10-01 |
| TheraFace Microcurrent (K212238) | Theragun, Inc. | 2021-09-29 |
| Dark Star Navigation Instrument System (K212028) | Republic Spine, LLC | 2021-09-27 |
| ZIIP+ Device (K212342) | Ziip, Inc. | 2021-09-23 |
| LED PHOTIC System (K211974) | Micromed S.P.A. | 2021-09-23 |
| StrataMR II Valves and Shunts (K212641) | Medtronic Neurosurgery | 2021-09-16 |
| Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation (K211389) | Magstim Company, Ltd. | 2021-09-14 |
| gammaCore Sapphire (K211856) | Electrocore, Inc. | 2021-09-10 |
| Iovera System (K211334) | Pacira Pharmaceuticals, Inc. | 2021-09-10 |
| Longeviti ClearFit™ OTS Cranial Implants (K212058) | Longeviti Neuro Solutions, LLC | 2021-09-08 |
| Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) (K211736) | Shenzhen Osto Technology Company Limited | 2021-09-05 |
| Numen Coil Embolization System; NumenFR Detachment System (K203625) | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2021-09-01 |
| Evo sEEG System (K211367) | Neuroone Medical Technologies Corp. | 2021-09-01 |
| Adhesive Electrode (K210448) | Shaoxing Yingtuo Healthcare Co., Ltd. | 2021-08-31 |
| Ceribell Instant EEG Headband (K210805) | Ceribell, Inc. | 2021-08-30 |
| Trevo NXT ProVue Retriever (K210502) | Stryker Neurovascular | 2021-08-27 |
| Virage Navigation System (K212023) | Zimmer Biomet Spine, Inc. | 2021-08-27 |
| Neuspera Neurostimulation System (NNS) (K202781) | Neuspera Medical, Inc. | 2021-08-27 |
| SOLOPASS System (K203251) | Intravent Medical Partners, LP | 2021-08-27 |
| ExcelsiusHub (K211616) | Globus Medical, Inc. | 2021-08-25 |
| ELAN 4 Electro Motor System (K203739) | Aesculap, Inc. | 2021-08-24 |
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |
| GX Navigation Instrument System (K202836) | Life Spine, Inc. | 2021-08-19 |
| STARband (K211376) | Orthomerica Products, Inc. | 2021-08-17 |
| Deep Transcranial Magnetic Stimulation (DTMS) System (K210201) | Brainsway , Ltd. | 2021-08-17 |
| Metallic Fabric Electrodes (K202636) | Guangzhou Xinbo Electronic Co., Ltd. | 2021-08-16 |
| MEGA-TMS (K192823) | Soterix Medical, Inc. | 2021-08-13 |
| VERTICALE Navigation Instruments (K212007) | Silony Medical GmbH | 2021-08-12 |
| 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes (K211202) | Stryker | 2021-08-06 |
| NeuroSENSE Monitoring System, Model NS-901 (K202621) | Neurowave Systems, Inc. | 2021-08-05 |
| Relivion (K212106) | Neurolief , Ltd. | 2021-08-02 |
| Elexir (K211380) | Nu Eyne Co., Ltd. | 2021-07-30 |
| NuVasive Pulse System (K210574) | Nu Vasive, Incorporated | 2021-07-29 |
| Electrode Market Disposable Surface Electrodes (K211839) | Electrode Market Co., Ltd. | 2021-07-28 |
| Vision Monitor - MonpackONE (K211643) | Metrovision | 2021-07-26 |
| xvision Spine system (XVS) (K211188) | Augmedics, Ltd. | 2021-07-19 |
| Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D (K211291) | Fiagon GmbH | 2021-07-19 |
| ARVIS Surgical Navigation System (K203115) | Insight Medical Systems, Inc. | 2021-07-14 |
| BioWave BioWraps (K203158) | Biowave Corporation | 2021-07-08 |
| StealthStation Spinous Process Clamps (K211442) | Medtronic Navigation | 2021-07-08 |
| Axium Detachable Coil; Axium Prime Detachable Coil (K203432) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021-07-07 |
| RICOH MEG (K210199) | Ricoh Company, Ltd. | 2021-07-02 |
| Stryker iBur hubs and cutting accessories (K210377) | Stryker Corporation | 2021-06-30 |
| CD Horizon Spinal System (K211596) | Medtronic | 2021-06-23 |