| MedCAD AccuShape Titanium Patient-Specific Cranial Implant (K220357) | Medcad | 2022-08-26 |
| BrainsWay Deep TMS System (K220819) | Brainsway , Ltd. | 2022-08-26 |
| StimOnTM Pain Relief System (GM2439) (K213802) | Gimer Medical Co., Ltd. | 2022-08-26 |
| Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 (K220998) | Shenzhen Kentro Medical Electronics Co., Ltd. | 2022-08-24 |
| NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health (K222230) | Neuronetics, Inc. | 2022-08-24 |
| 2.1 x 255mm Drill, 22mm Stop (K213072) | Biomet Micofixation | 2022-08-23 |
| REAL INTELLIGENCE CORI (K221224) | Blue Belt Technologies, Inc. | 2022-08-19 |
| Disposable Brain Biopsy Needle 2.0 (K220897) | PAJUNK GmbH Medizintechnologie | 2022-08-17 |
| iSyncWave (K220056) | iMediSync, Inc. | 2022-08-10 |
| “POINT” Kinguide Robotic-Assisted Surgical System (K220241) | Point Robotics MedTech, Inc. | 2022-08-09 |
| Spineology Navigation Instruments (K213876) | Spineology, Inc. | 2022-08-05 |
| Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series) (K220524) | Well-Life Healthcare Limited | 2022-08-04 |
| QScreen (K220139) | Path Medical GmbH | 2022-08-03 |
| OptiVu ROSA MxR (K220733) | Orthosoft Inc (D/B/A Zimmer Cas) | 2022-07-29 |
| Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) (K221251) | Guangzhou Huakai Electronic Technology Co., Ltd. | 2022-07-29 |
| Real Intelligence Cori (K220958) | Blue Belt Technologies, Inc. | 2022-07-27 |
| BLUE 400 (K211346) | Carl Zeiss Meditec, AG | 2022-07-22 |
| Cionic Neural Sleeve NS-100 (K221823) | Cionic | 2022-07-21 |
| TruDi Shaver Blade (K221037) | Acclarent, Inc. | 2022-07-20 |
| Nerve Tape (K210665) | Biocircuit Technologies, Incorporated | 2022-07-15 |
| NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health (K220127) | Neuronetics, Inc. | 2022-07-15 |
| NomadAir PMU810 (K220631) | Neurotronics, Inc. | 2022-07-15 |
| Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V (K220348) | Remex Medical Corporation | 2022-07-14 |
| CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems (K220040) | Medos International SARL | 2022-07-14 |
| E-GPS Navigated Instruments (K220862) | Precision Spine, Inc. | 2022-07-14 |
| Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit (K221098) | Stryker Corporation | 2022-07-12 |
| Noodle (K220573) | Pourang Bral, Dds, LLC | 2022-07-09 |
| SkyWalker Total Knee System (K213873) | Microport Navibot International, LLC | 2022-07-07 |
| Cerebra Sleep System (K213007) | Cerebra Medical , Ltd. | 2022-07-06 |
| SURGIVISIO Device (K221028) | Ecential Robotics | 2022-07-06 |
| ChoiceSpine Navigation System (K220024) | Choice Spine, LLC | 2022-07-06 |
| Hanger Cranial Band 3D (K203134) | Symbion Logistics, LLC | 2022-07-01 |
| Sugita AVM Microclip Applier (K221524) | Mizuho America, Inc. | 2022-06-24 |
| NeuroLine Disposable Cranial Perforator with Hudson end (K213228) | Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. | 2022-06-20 |
| Seer Home (K212788) | Seer Medical Pty, Ltd. | 2022-06-16 |
| EEG-acp (K212325) | Somnomedics GmbH | 2022-06-15 |
| Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 (K221384) | Hivox Biotek, Inc. | 2022-06-11 |
| Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 (K221087) | Medtronic Navigation, Inc. | 2022-06-10 |
| Nalu Neurostimulation System (K221376) | Boston Scientific Neuromodulation | 2022-06-10 |
| Rune Labs Tremor Transducer System (K213519) | Rune Labs, Inc. | 2022-06-10 |
| MyCRO Band (K213587) | Otto Bock Healthcare LP | 2022-06-09 |
| EarliPoint System (K213882) | Earlitec Diagnostics, Inc. | 2022-06-08 |
| Drug Relief v1 (K221231) | Dyansys, Inc. | 2022-06-06 |
| KLS Martin Neuro Rongeurs (K210741) | KLS-Martin L.P. | 2022-06-03 |
| Knee 3 (K220652) | Brainlab AG | 2022-06-03 |
| CoreLink Navigation Instruments (K220973) | Corelink, LLC | 2022-06-01 |
| Spine Guidance Software, Stryker Q Guidance System (K220593) | Stryker Leibinger GmbH & Co KG | 2022-05-27 |
| VisAR (K220146) | Novarad Corporation | 2022-05-27 |
| Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) (K220578) | Bozhou Rongjian Medical Appliance Co., Ltd. | 2022-05-25 |
| Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments (K221180) | Medtronic Sofamor Danek USA, Inc. | 2022-05-25 |
| 7D Surgical System - Percutaneous Application (7D Flash Frame) (K220522) | 7D Surgical | 2022-05-20 |
| iovera System (K220656) | Pacira Biosciences, Inc. | 2022-05-20 |
| Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) (K220485) | The Anspach Effort, Inc. | 2022-05-19 |
| Quell-FM (DEN210046) | Neurometrix, Inc. | 2022-05-18 |
| Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) (K210615) | Thompson Surgical Instruments, Inc. | 2022-05-13 |
| Universal Pilot Guidance Instrument System (K213491) | Ctl Medical Corporation | 2022-05-12 |
| ANSiStim-PP (K220397) | Dyansys, Inc. | 2022-05-12 |
| Wireless EEG System (K213299) | Pascall Systems, Inc. | 2022-05-11 |
| TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) (K213788) | Dongguan Bohuikang Technology Co.,Ltd | 2022-05-06 |
| NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar (K212289) | Neuronetics, Inc. | 2022-05-06 |
| Disposable EEG cable (K213884) | Shenzhen Changke Connect Electronics Co., Ltd. | 2022-05-06 |
| WAVi SCAN EEG System and Accessories (K213900) | Wavi Co. | 2022-05-06 |
| Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set (K212756) | Medos International SARL | 2022-05-05 |
| ROSA ONE Brain application (K214065) | Medtech S.A.S | 2022-05-04 |
| ExactechGPS® System (K213877) | Blue Ortho | 2022-05-02 |
| TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) (K220283) | Hong Qiangxing (Shenzhen) Electronics Limited | 2022-05-02 |
| Camber Spine Navigation System (K220038) | Camber Spine Technologies | 2022-04-29 |
| MyoCycle MC-2 (Home / Home + / Pro / Pro +) (K213925) | Myolyn, LLC | 2022-04-25 |
| TENS device-EmeTerm 2, Model: YF-ZTY-E2 (K220503) | Wat Medical Technology, Inc. | 2022-04-23 |
| ROSA® Knee System (K213708) | Orthosoft Inc (D/B/A Zimmer Cas) | 2022-04-22 |
| Brainlab Elements Guide XT, Guide 3.0 (K213930) | Brainlab AG | 2022-04-19 |
| TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555) (K220152) | Hong Qiangxing (Shenzhen) Electronics Limited | 2022-04-19 |
| Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 (K212377) | Ningbo Medkinetic Medical Device Co., Ltd. | 2022-04-15 |
| Mako Total Knee Application (K220459) | Mako Surgical Corp. | 2022-04-15 |
| Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning (K212245) | Brainlab AG | 2022-04-13 |
| ClearPoint Array System (version 1.1) (K214040) | ClearPoint Neuro, Inc. | 2022-04-12 |
| visor2 system (K210109) | Eemagine Medical Imaging Solutions GmbH | 2022-04-08 |
| ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System (K220625) | Remed Co., Ltd. | 2022-04-06 |
| TENS and EMS Stimulation (OTC) (K212184) | Changsha Yuwen Medical Equipment Co., Ltd. | 2022-04-01 |
| TENS & PMS Unit (K220005) | Shenzhen Yuehua Xinsen Technology Co., Ltd. | 2022-04-01 |
| NEXXT SPINE NAVIGATION System (K220291) | Nexxt Spine, LLC | 2022-03-31 |
| REAL INTELLIGENCE CORI (K220255) | Blue Belt Technologies, Inc. | 2022-03-29 |
| BrainTemp Neonate System (BTNeo System) (DEN200042) | Brain Temp, Inc. | 2022-03-29 |
| Intracept Intraosseous Nerve Ablation System (K213836) | Relievant Medsystems, Inc. | 2022-03-11 |
| Personal Kinetigraph (PKG) System Gen 2 Plus (K211887) | Gkc Manufacturing Pty, Ltd. | 2022-03-11 |
| NextAR™ TKA Platform My Knee PPS (K213751) | Medacta International S.A. | 2022-03-10 |
| SafeOp 2: Neural Informatix System (K213849) | Alphatec Spine, Inc. | 2022-03-09 |
| TENS & EMS DEVICE (Model: FM-B2403A) (K213741) | Shenzhen Jian Feng Electronic Technology Co., Ltd. | 2022-03-08 |
| BTL-995-rTMS (K212723) | BTL Industries, Inc. | 2022-03-04 |
| MyndMove 2.0 (K212149) | Myndtec, Inc. | 2022-03-03 |
| TENS & EMS Device (K213835) | Shenzhen Jian Feng Electronic Technology Co., Ltd. | 2022-03-03 |
| Sugita AVM Microclips (K211183) | Mizuho America, Inc. | 2022-03-02 |
| Masimo SedLine Sedation Monitor and Accessories (K203113) | Masimo Corporation | 2022-02-25 |
| Luminice (K214100) | Premier North America, Inc. | 2022-02-24 |
| StimRouter Neuromodulation System (K211965) | Bioness, Inc. | 2022-02-23 |
| Well-Life TENS/EMS/Heating Stimulator (K213091) | Well-Life Healthcare Limited | 2022-02-19 |
| TENS & PMS (Model: SM9126) (K220150) | Hong Qiangxing (Shenzhen) Electronics Limited | 2022-02-17 |
| Cionic Neural Sleeve NS-100 (K213622) | Cionic | 2022-02-14 |
| NervAlign Nerve Cuff (K202234) | Renerve, Ltd. | 2022-02-10 |
| Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments, and CD Horizon™ Solera™ Voyager™ Spinal System Navigated, Guided, and Powered Drivers (K214011) | Medtronic Sofamor Danek USA, Inc. | 2022-02-09 |