| TENS and EMS Stimulation (OTC) (K230174) | Changsha Yuwen Medical Equipment Co., Ltd. | 2023-03-20 |
| Prism (K222101) | Graymatters Health , Ltd. | 2023-03-17 |
| NeuroRPM (K221772) | New Touch Digital, Inc. | 2023-03-17 |
| MagVenture TMS Atlas Neuro Navigation System (K221544) | Tonica Elektronik A/S | 2023-03-17 |
| Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ (K223154) | Magstim Company, Ltd. | 2023-03-16 |
| iSyncBrain©-C (K222838) | iMediSync, Inc. | 2023-03-16 |
| APEX 6 (K220122) | Rf Innovations, Inc. | 2023-03-15 |
| Remi Robotic Navigation System (K223350) | Fusion Robotics, LLC | 2023-03-13 |
| CloudTMS for OCD (K221129) | Teleemg, LLC | 2023-03-10 |
| PathKeeper System (K222355) | Pathkeeper Surgical , Ltd. | 2023-03-08 |
| Rebellion, Phantom Multi-Bite Kerrison Rongeur (K230256) | Morpheus AG | 2023-03-03 |
| NEBA® Compact EEG2R Mobile Headset (K223628) | Neba Health, LLC | 2023-03-02 |
| Disposable Pre-calibrated Brain Biopsy Needle 2.0 (K230201) | PAJUNK GmbH Medizintechnologie | 2023-02-22 |
| PATI (Protector Against Tongue Injury) (K221469) | Neurovice, LLC | 2023-02-22 |
| Rosa Knee System (K230180) | Orthosoft Inc (D/B/A Zimmer Cas) | 2023-02-22 |
| Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System (K212194) | Stryker Corporation | 2023-02-16 |
| Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System (K223767) | Stryker Leibinger GmbH & Co KG | 2023-02-13 |
| SMILE (K213629) | Nu Eyne Co., Ltd. | 2023-02-12 |
| Okti (K230073) | Compumedics Limited | 2023-02-09 |
| External Drainage System (K221694) | Jmed(Shenzhen) Technology Limited | 2023-02-09 |
| Nerivio (K223169) | Theranica Bioelectronics , Ltd. | 2023-02-06 |
| DeltaScan Patch (K222671) | Prolira B.V. | 2023-02-02 |
| DeltaScan Monitor (K222680) | Prolira B.V. | 2023-02-02 |
| Polaris Valve Electronic Reading Instrument (K222422) | Sophysa | 2023-02-02 |
| Garment Electrodes (K222863) | Tone-A-Matic International, Inc. | 2023-02-01 |
| Certas Plus Programmable Valves (K223330) | Integra Lifesciences Production Corporation | 2023-02-01 |
| Naviswiss Knee (K223351) | Naviswiss AG | 2023-01-31 |
| BrainView QEEG Software (K212684) | Medeia, Inc. | 2023-01-28 |
| 360CAS (K223927) | Kico Knee Innovation Company Pty Limited | 2023-01-27 |
| SPRINT Peripheral Nerve Stimulation (PNS) System (K223306) | Spr Therapeutics, Inc. | 2023-01-25 |
| Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) (K222879) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2023-01-24 |
| Blueprint Mixed Reality system (K222510) | Tornier S.A.S. | 2023-01-20 |
| pRESET Thrombectomy Device (K222848) | Phenox Limited | 2023-01-20 |
| TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) (K223108) | Medos International SARL | 2023-01-19 |
| Self-adhesive Electrode (K222252) | Shenzhen Roundwhale Technology Co. , Ltd. | 2023-01-19 |
| Disposable Non-invasive EEG Sensor (K220448) | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2023-01-19 |
| MONTAGE Settable, Resorbable Bone Putty (K221933) | Orthocon, Inc. | 2023-01-13 |
| Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ (K222171) | Magstim Company, Ltd. | 2023-01-13 |
| Neuronaute with IceCap 2 & IceCap 2 Small (K223644) | Bioserenity | 2023-01-12 |
| Alpha Control Liner System (ACLS) (K223738) | Coapt | 2023-01-11 |
| Curiteva Navigation System (K223200) | Curiteva, Inc. | 2023-01-06 |
| EZ-STIK Electrodes (K223775) | South Dakota Partners | 2023-01-03 |
| ControlSeal Electrode (ELSB) (K223605) | Coapt | 2022-12-30 |
| Persyst 15 EEG Review and Analysis Software (K222002) | Persyst Development Corporation | 2022-12-30 |
| Reflow System Mini and ReFlow Mini Flusher (K223603) | Anuncia Medical, Inc. | 2022-12-29 |
| VERTICALE® Navigation Instruments (K223649) | Silony Medical GmbH | 2022-12-22 |
| AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) (K222867) | Andon Health Co, Ltd. | 2022-12-21 |
| Caduceus S (K220554) | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | 2022-12-16 |
| Target Tetra Detachable Coils (K222533) | Stryker Neurovascular | 2022-12-14 |
| Conductive Gel (K222770) | Top-Rank Health Care Co., Ltd. | 2022-12-13 |
| Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx (K212071) | Cefaly Technology | 2022-12-13 |
| RobPath® Total Hip Application (K220774) | Hangzhou Lancet Robotics Co., Ltd. | 2022-12-09 |
| SeaSpine 7D Navigation Instruments (K222753) | SeaSpine Orthopedics Corporation | 2022-12-09 |
| IRRAflow Active Fluid Exchange System (AFES) (K222471) | Irras USA | 2022-12-08 |
| Optima Coil System (K223386) | Balt USA, LLC | 2022-12-06 |
| iCE-SG2 Subcutaneous Electrode Kit (K222706) | Ice Neurosystems, Inc. | 2022-12-06 |
| Neuron-Spectrum-AM with Neuron-Spectrum.NET Software (K220254) | Neurosoft , Ltd. | 2022-11-30 |
| E3 and Profile (K221471) | Diagnosys, LLC | 2022-11-22 |
| WISE Cortical Strip (WCS) (K221123) | Wise S.R.L. | 2022-11-22 |
| Cala kIQ (K222237) | Cala Health, Inc. | 2022-11-22 |
| Vision Monitor- MonCvONE (K212936) | Metrovision | 2022-11-21 |
| Parky App (K220820) | H2o Bilisim Yazilim | 2022-11-17 |
| xvision Spine System (K220905) | Augmedics, Ltd. | 2022-11-17 |
| Everyway Analog OTC TENS (K222488) | Everyway Medical Instruments Co.,Ltd | 2022-11-15 |
| 2.1 x 255mm Drill, 22mm Stop (K223199) | Biomet Microfixation | 2022-11-15 |
| Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid (K211954) | Spes Medica Srl | 2022-11-10 |
| Self-adhesive Electrode (K222453) | Guangdong Comytens Medical Technology Co., Ltd. | 2022-11-04 |
| ORiGO System (K213697) | Bien-Air Surgery SA | 2022-10-31 |
| Remi Robotic Navigation System (K223070) | Fusion Robotics, LLC | 2022-10-28 |
| PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) (K214109) | Kontour(Xi’An) Medical Technology Co., Ltd. | 2022-10-28 |
| Cirq Arm System (2.0);Alignment System Spine (K222966) | Brainlab AG | 2022-10-27 |
| Intracept Intraosseous Nerve Ablation System (K222281) | Relievant Medsystems, Inc. | 2022-10-26 |
| Neurosteer EEG Recorder (K221563) | Neurosteer, Inc. | 2022-10-24 |
| MCI-Neuro Fixation System (K212391) | Mci Medical Concept Innovation, Inc. | 2022-10-21 |
| PureLift Pro Plus (K221443) | Xtreem Pulse, LLC | 2022-10-21 |
| Electronic Pulse Stimulator (K221992) | Beijing Choice Electronic Technology Co., Ltd. | 2022-10-21 |
| Evo® sEEG System (K222404) | Neuroone Medical Technologies Corp. | 2022-10-20 |
| Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves (K221840) | Integra Lifesciences Production Corporation | 2022-10-14 |
| CUVIS-spine (K222698) | Curexo, Inc. | 2022-10-07 |
| Rebellion; Phantom Multi-Bite Kerrison Rongeur (K221818) | Morpheus AG | 2022-10-07 |
| ROSA® Knee System (K221928) | Orthosoft D/B/A Zimmer Cas | 2022-10-04 |
| SpineAR SNAP (K213034) | Surgical Theater, Inc. | 2022-09-29 |
| Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth(TM) Edition (K222383) | Medtronic Sofamor Danek USA, Inc. | 2022-09-29 |
| ReFlow System Mini (K221918) | Anuncia Medical, Inc. | 2022-09-29 |
| Conductive Gel (K221724) | Tone-A-Matic International, Inc. | 2022-09-23 |
| Talee, Talee PostOP (K220681) | Invent Medical USA, LLC | 2022-09-22 |
| SomnoMetry (K221179) | Neumetry Medical, Inc. | 2022-09-21 |
| Neuro Omega System, NeuroSmart System (K220553) | Alpha Omega Engineering , Ltd. | 2022-09-16 |
| ClearPoint System (K222519) | ClearPoint Neuro, Inc. | 2022-09-16 |
| TrueBalance™ Surgical System (K220830) | These Three Medical, LLC | 2022-09-15 |
| iRelieve Microcurrent Pain Relief System (K212618) | Fast Track Technologies, Inc. | 2022-09-14 |
| Transcutaneous Electrical Nerve Stimulator Model: ST-304 (K221092) | Shenzhen Future Electronic Co., Ltd. | 2022-09-13 |
| Primary Relief (K221425) | Dyansys, Inc. | 2022-09-13 |
| Dexus Prosthetics System (Model: MSL1, MSR1) (K220002) | Zhejiang Qiangnao Technology Co.,Ltd | 2022-09-09 |
| Cranial EM System (K213989) | Brainlab AG | 2022-09-08 |
| Matreneu Percutaneous Balloon Compression Kit (K220920) | Shenzhen Shineyard Medical Device Co. , Ltd. | 2022-09-07 |
| Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K (K220177) | Magnus Medical, Inc. | 2022-09-01 |
| Wireless TENS/EMS, Bruno, Aela (K220997) | Zmi Elecronics , Ltd. | 2022-09-01 |
| Knee+ (K220104) | Pixee Medical | 2022-09-01 |
| Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System (K221618) | Brainlab AG | 2022-08-30 |