| BTL-785BNF Handpiece (K232172) | BTL Industries, Inc. | 2023-09-18 |
| ImPACT Version 4 (K231688) | Impact Applications, Inc. | 2023-09-16 |
| ClearPoint Array System (Version 1.2) (K232102) | ClearPoint Neuro, Inc. | 2023-09-15 |
| Avologi Gel Primer (Model: Av25) (K220735) | Premier North America, Inc. | 2023-09-15 |
| Ultimate rTMS; Yingchi rTMS (K230735) | Brain Ultimate, Inc. | 2023-09-13 |
| Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial (K223864) | Brainlab AG | 2023-09-09 |
| OnPoint Augmented Reality Spine System (K231284) | Onpoint Surgical, Inc. | 2023-09-08 |
| STarFix Designer Software C0265 (K231141) | FHC, Inc. | 2023-09-08 |
| Fusion Robotic Navigation System (K232413) | Alphatec Spine, Inc. | 2023-09-08 |
| Zeta Cranial Navigation System (K230661) | Zeta Surgical | 2023-09-08 |
| Brain Anesthesia Response Monitor (Bar Monitor) (K213273) | Cortical Dynamics , Ltd. | 2023-09-01 |
| Q21 (K221959) | Neurofield, Inc. | 2023-08-31 |
| HOLO Portal™ Surgical Guidance System (K231611) | Surgalign Spine Technologies | 2023-08-31 |
| MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption (K230014) | Tonica Elektronik A/S | 2023-08-25 |
| Unicare (K-UNICARE-USA) (K231053) | Tenscare, Ltd. | 2023-08-18 |
| SPARK Scan (K231457) | Spark Neuro, Inc. | 2023-08-18 |
| Dreem 3S (K223539) | Beacon Biosignals, Inc. | 2023-08-18 |
| Cadwell Guardian (K230415) | Cadwell Industries, Inc. | 2023-08-17 |
| SOMNUM (V.1.1.2.) (K223922) | Honeynaps Co., Ltd. | 2023-08-16 |
| CoreLink Navigation Instruments (K232116) | Corelink, LLC | 2023-08-16 |
| Stryker Resorbable Fixation System (K231208) | Stryker Leibinger GmbH & Co KG | 2023-08-14 |
| ArtiFascia (K223445) | Nurami Medical , Ltd. | 2023-08-10 |
| Conductive Silicone Rubber Electrode (K231167) | Guangzhou Xinbo Electronic Co., Ltd. | 2023-08-09 |
| Conductive carbon film electrode (K231164) | Guangzhou Xinbo Electronic Co., Ltd. | 2023-08-09 |
| Ceribell Instant EEG Headband (K232052) | Ceribell, Inc. | 2023-08-08 |
| Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine (K223553) | Brainlab AG | 2023-08-02 |
| REAL INTELLIGENCE™ CORI™ (K231963) | Blue Belt Technologies, Inc. | 2023-08-01 |
| HJY VisualNext Endoscopic Vision System (K222735) | Hjy Smart Medical Device Co., Ltd. | 2023-07-28 |
| SURGIVISIO Device (K231886) | Ecential Robotics | 2023-07-27 |
| ApolloKnee (K231172) | Corin U.S.A. Limited | 2023-07-26 |
| NextAR™ Spine Platform (K223769) | Medacta International S.A. | 2023-07-21 |
| TruDi® Navigation System V3 (FG-2000-00) (K231862) | Acclarent, Inc. | 2023-07-21 |
| Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI (K223288) | Brainlab AG | 2023-07-21 |
| ROSA ONE Brain Application (K231103) | Medtech S.A.S | 2023-07-20 |
| ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System (K223301) | Spinecraft, LLC | 2023-07-20 |
| Nu-beca Transcutaneous Electrical Nerve Stimulation (K223151) | Nu-Beca & Maxcellent Co. | 2023-07-19 |
| Robotic Graft Delivery Instruments (K230716) | Medtronic Sofamor Danek, Inc. | 2023-07-18 |
| “POINT” Kinguide Agile Hybrid Navigation System (K230087) | Point Robotics MedTech, Inc. | 2023-07-17 |
| NaviNetics Reusable Stereotactic System (NN1000) (K231392) | Navinetics, Inc. | 2023-07-14 |
| Zavation Navigation Instrument System (K223808) | Zavation Medical Products, LLC | 2023-07-12 |
| REMI Remote EEG Monitoring System (K230933) | Epitel, Inc. | 2023-06-30 |
| EarliPoint (K230337) | Earlitec Diagnostics, Inc. | 2023-06-29 |
| Phantom XL Insulated Dilators (K231691) | TeDan Surgical Innovations, Inc. | 2023-06-29 |
| NeuroSwift Pro (K223047) | Neurobit Technologies Co., Ltd. | 2023-06-29 |
| SQ.line KERRISON (K223596) | Aesculap, Inc. | 2023-06-29 |
| Medi Lift PLUS (K220198) | Ya-Man, Ltd. | 2023-06-28 |
| RI.KNEE Adjustable Tibia Cut Guide (K230876) | Enztec Limited | 2023-06-27 |
| VADER® Pedicle System Navigated Instruments (K230861) | Icotec AG | 2023-06-27 |
| EUROPA™ Navigated Instruments (K230369) | MiRus, LLC | 2023-06-23 |
| ActiGraph LEAP activity monitor (ActiGraph LEAP) (K231532) | Actigraph, LLC | 2023-06-23 |
| Talee, Talee PostOp (K230444) | Invent Medical USA, LLC | 2023-06-22 |
| CUVIS-spine (K223558) | Curexo, Inc. | 2023-06-22 |
| PureLift Pro Edition (K230506) | Xtreem Pulse | 2023-06-21 |
| Sparrow Ascent (K230796) | Spark Biomedical, Inc. | 2023-06-20 |
| Sinobot X1 (K220072) | Sinovation (Beijing) Medical Technology Co., Ltd. | 2023-06-18 |
| OptiVu™ ROSA® MxR (K230567) | Orthosoft Inc (D/B/A Zimmer Cas) | 2023-06-13 |
| LVIS NeuroMatch (K222450) | LVIS Corporation | 2023-06-09 |
| OCD MT Cap (85-00397-000) (K231350) | Neuronetics | 2023-06-08 |
| SomniCheck (K223676) | Brainmatterz, LLC | 2023-06-01 |
| CD Horizon™ Spinal System (K231184) | Medtronic Sofamor Danek USA, Inc. | 2023-05-26 |
| S-COMP Reform® POCT Navigation Instruments (K231229) | Precision Spine, Inc. | 2023-05-25 |
| Ceribell Status Epilepticus Monitor (K223504) | Ceribell, Inc. | 2023-05-23 |
| TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) (K230443) | Jiangxi Royall Smart Technology Co., Ltd. | 2023-05-22 |
| Spencer Probe Depth Electrodes (K223269) | Ad-Tech Medical Instrument Corporation | 2023-05-18 |
| Anchor Bolts as Accessories to Depth Electrodes (K223276) | Ad-Tech Medical Instrument Corporation | 2023-05-18 |
| SAVI Dual (TM) Migraine Therapy (K230358) | Eneura, Inc. | 2023-05-16 |
| HEATING TENS/EMS, FT-810R (K223308) | Hivox Biotek, Inc. | 2023-05-13 |
| Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039 (K222870) | Shenzhen Kentro Medical Electronics Co., Ltd. | 2023-05-10 |
| Stanza (DEN220083) | Swing Therapeutics, Inc. | 2023-05-09 |
| Tens & Ems Device (K223825) | Shenzhen Jian Feng Electronic Technology Co., Ltd. | 2023-05-09 |
| Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A) (K223428) | Shenzhen Leqing Medical Instrument Co., Ltd. | 2023-05-08 |
| Rod Registration Frame (K230989) | Nu Vasive, Incorporated | 2023-05-05 |
| Hubly Electric Drill (H100) (K230619) | Hubly, Inc. | 2023-05-04 |
| CoreLink Navigation Instruments (K230880) | Corelink, LLC | 2023-05-02 |
| Excella Navigation Instruments (K223511) | Innovasis, Inc. | 2023-05-02 |
| ENT EM (K223734) | Brainlab AG | 2023-04-27 |
| Myolift QT (K213078) | Johari Digital Healthcare Limited | 2023-04-27 |
| Cumulus Functional Neurophysiology Platform (K221963) | Cumulus Neuroscience Limited | 2023-04-27 |
| TENS7000 Rechargeable (Model:TENS7000 Rechargeable) (K230829) | Chongqing Rob Linka Science and Technology Co., Ltd. | 2023-04-26 |
| TMINI™ Miniature Robotic System (K230202) | THINK Surgical, Inc. | 2023-04-25 |
| Paradigm System (K222291) | Proprio, Inc. | 2023-04-21 |
| Anatase Spine Surgery Navigation System (K230783) | Remex Medical Corp. | 2023-04-21 |
| Knee+ (K230789) | Pixee Medical | 2023-04-21 |
| STARband 3D (K223238) | Orthomerica Products, Inc. | 2023-04-20 |
| Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial (K223552) | Brainlab AG | 2023-04-19 |
| SENSOSEEG Depth Electrodes (K213170) | Sensomedical Labs, Ltd. | 2023-04-18 |
| Localite TMS Navigator TS (K223577) | Localite GmbH | 2023-04-17 |
| NTX100 Tonic Motor Activation (NTX100 ToMAc) System (DEN220059) | Noctrix Health, Inc. | 2023-04-17 |
| Neuspera Nuity System (K221303) | Neuspera Medical, Inc. | 2023-04-11 |
| TENS and EMS Stimulation (OTC) (K230164) | Changsha Yuwen Medical Equipment Co., Ltd. | 2023-04-10 |
| Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) (K223640) | Axogen Corporation | 2023-04-07 |
| Mazor X System (Mazor X Stealth Edition) (K230064) | Mazor Robotics , Ltd. | 2023-04-07 |
| NeuroStar Advanced Therapy System (Version 3.7) (K230029) | Neuronetics | 2023-04-04 |
| ROSA® Knee System (K230243) | Orthosoft D/B/A Zimmer Cas | 2023-03-29 |
| Trevo NXT ProVue Retriever (K223305) | Stryker Neurovascular | 2023-03-29 |
| Starly pad (K221589) | Shenzhen Xingyuanli Technology Co., Ltd. | 2023-03-24 |
| ATEC Lateral Navigation Instruments (K223765) | Alphatec Spine, Inc. | 2023-03-23 |
| Motive™ Electrode (K230533) | Cymedica Orthopedics, Inc. | 2023-03-22 |
| Ceribell Instant EEG Headcap (K223086) | Ceribell, Inc. | 2023-03-22 |
| TENS and EMS Stimulation (OTC) (K230163) | Changsha Yuwen Medical Equipment Co., Ltd. | 2023-03-20 |