| Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System (K233542) | Stryker Leibinger GmbH & Co KG | 2024-03-14 |
| Myriad SPECTRA Light Source (K232567) | Nico Corporation | 2024-03-14 |
| OTS Hip (K232140) | Ortoma AB | 2024-03-11 |
| ALGO Pro Newborn Hearing Screener (ALGO Pro) (K233649) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2024-03-08 |
| SleepStageML (K233438) | Beacon Biosignals, Inc. | 2024-03-08 |
| Knee+ (K233899) | Pixee Medical | 2024-03-08 |
| Neo ADVISE software (K230195) | Comerge AG | 2024-03-08 |
| evoDrill Cranial Perforator (K231403) | Evonos GmbH & Co. KG | 2024-03-06 |
| S21 OTC Transcutaneous Electrical Nerve Stimulator (K233095) | Micro Current Technology, Inc. | 2024-03-01 |
| Muscle Stimulator (K231648) | Shenzhen Yiran Intelligent Co., Ltd. | 2024-03-01 |
| BIS™ Advance Monitoring System (K230693) | Covidien, LLC | 2024-02-26 |
| TENS device-HeadaTerm 2 (Model: YF-HT2) (K230782) | Wat Medical Technology, Inc. | 2024-02-26 |
| Navigation Tracking Instruments (K232800) | SI-BONE, Inc. | 2024-02-23 |
| ENSO (Model 2) (K233784) | Hinge Health, Inc. | 2024-02-23 |
| ROSA® Shoulder System (K233199) | Orthosoft Inc (D/B/A Zimmer Cas) | 2024-02-21 |
| Montage Flowable Settable, Resorbable Bone Paste (K232771) | Orthocon, Inc. | 2024-02-16 |
| Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System (K240137) | Neos Surgery S.L | 2024-02-16 |
| EpiMonitor (K232915) | Empatica S.r.l. | 2024-02-15 |
| NerveTape (K233533) | Biocircuit Technologies, Inc. | 2024-02-12 |
| EMS/TENS Massager Device (K233040) | Shenzhen Imdk Medical Technology Co., Ltd. | 2024-02-12 |
| Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) (K233092) | Chongqing Rob Linka Science and Technology Co., Ltd. | 2024-02-12 |
| Facial Toning device (UIC-189); Facial Toning device (UIC-589) (K233667) | Body Trim Industrial Co., Ltd. | 2024-02-12 |
| VERZA™ High Speed Drills (K233638) | Globus Medical, Inc. | 2024-02-09 |
| ZapStim Controller Application (Z1023) (K233631) | Revital Lab, Inc. | 2024-02-09 |
| Vecttor VT-300 (K231575) | Artaflex, Inc. | 2024-02-08 |
| X-trodes System M (K232210) | X-Trodes | 2024-02-04 |
| CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) (K232890) | Integra Lifesciences Production Corporation | 2024-02-04 |
| BTL-99-OC (K230657) | BTL Industries, Inc. | 2024-02-01 |
| Rebuilder Nerve Guidance Conduit (K230794) | Celestray Biotech Company, LLC., | 2024-01-29 |
| ExactechGPS® System (K233299) | Blue Ortho | 2024-01-26 |
| Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500) (K231423) | Shenzhen Roundwhale Technology Co. , Ltd. | 2024-01-22 |
| Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) (K233461) | Hi-Dow International, Inc. | 2024-01-19 |
| Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter (K233445) | Integra Lifesciences Production Corporation | 2024-01-17 |
| Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® (K233293) | Neurosigma, Inc. | 2024-01-16 |
| ClearPoint Bone Screw Fiducials (K233144) | ClearPoint Neuro, Inc. | 2024-01-12 |
| ClearPointer Optical Navigation Wand (K233155) | ClearPoint Neuro, Inc. | 2024-01-12 |
| SmartFrame OR (K233141) | ClearPoint Neuro, Inc. | 2024-01-12 |
| BrainSee (DEN220066) | Darmiyan, Inc. | 2024-01-11 |
| Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe (K232995) | Shenzhen Roundwhale Technology Co. , Ltd. | 2024-01-11 |
| Axon Therapy (K233364) | Neuralace Medical, Inc. | 2024-01-10 |
| Numen Coil Embolization System; NumenFR Detachment System (K232955) | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2024-01-10 |
| Zeta Cranial Navigation System (ZNS131-US) (K233903) | Zeta Surgical, Inc. | 2024-01-10 |
| autoSCORE (K231068) | Holberg Eeg AS | 2024-01-07 |
| REMI AI Discrete Detection Module (K231779) | Epitel, Inc. | 2024-01-03 |
| NQ TMS for MDD (NQv1-MU-01) (K232688) | Neuroqore, Inc. | 2023-12-29 |
| EvoWalk 1.0 System (K230997) | Evolution Devices, Inc. | 2023-12-28 |
| Nurochek-II System (K231914) | Headsafe Mfg Pty, Ltd. | 2023-12-27 |
| CloudTMS Edge for OCD (K233742) | Teleemg, LLC | 2023-12-22 |
| Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode) (K221199) | Green Island International Tcm Group Limited | 2023-12-19 |
| Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set (K233448) | Integra Lifesciences Production Corporation | 2023-12-19 |
| Ova+ (K-OVAP-USA) (K230926) | Tenscare, Ltd. | 2023-12-15 |
| VELYS™ Robotic-Assisted Solution (K233227) | Depuy Ireland UC | 2023-12-14 |
| Kalitec Navigated Instrument System (K232572) | Kalitec Direct, LLC Doing Business AS Kalitec Medical | 2023-12-13 |
| NeuroStar Advanced Therapy System (Version 3.8) (K233621) | Neuronetics | 2023-12-13 |
| Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412) (K232517) | Shenzhen Kentro Medical Electronics Co., Ltd. | 2023-12-08 |
| OneRF Ablation System (K231675) | Neuroone Medical Technologies Corp. | 2023-12-06 |
| Medical Disposable Sterile Needle Electrode (K232581) | Suzhou Haishen Medical Device Associates Co., Ltd. | 2023-12-04 |
| Surgify Halo (K232684) | Surgify Medical OY | 2023-11-29 |
| ClearPoint System (Software Version 2.2) (K233243) | ClearPoint Neuro, Inc. | 2023-11-27 |
| MF SC Facial Toning System (K233525) | Micro Current Technology, Inc. | 2023-11-24 |
| Absorbable Cranial Flap Fixation System (K221606) | Chendu Medart Medical Scientific Co., Ltd. | 2023-11-21 |
| CranioXpand (K230211) | KLS-Martin L.P. | 2023-11-21 |
| Digital ClarusScope System, Digital NeuroPEN System (K223615) | Clarus Medical, LLC | 2023-11-21 |
| Nu Skin RenuSpa iO (K232001) | Nse Products, Inc. | 2023-11-21 |
| Beagank 4T Plus (K233010) | Belega, Inc. | 2023-11-21 |
| RIWOtrack Navigation System (K230700) | Fiagon GmbH | 2023-11-20 |
| ExactechGPS® Total Ankle Application (K232521) | Blue Ortho | 2023-11-16 |
| Vital™ Navigation System (K233443) | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 2023-11-16 |
| ROSA Partial Knee System (K232533) | Orthosoft D/B/A Zimmer Cas | 2023-11-16 |
| Neuronaute Plus (K231366) | Bioserenity Sas | 2023-11-09 |
| Longeviti ClearFit OTS Cranial Implant (K231920) | Longeviti Neuro Solutions, LLC | 2023-11-09 |
| NerivioInfinity (K232152) | Theranica Bioelectronics , Ltd. | 2023-11-08 |
| Axium Detachable Coil; Axium Prime Detachable Coil (K233420) | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | 2023-11-07 |
| ManaFlexx 2 (model: MF002-RX, MF002-OTC) (K231569) | Manamed, Inc. | 2023-11-03 |
| STELLAR Knee (K232176) | Polarisar, Inc. | 2023-11-02 |
| VersaWrap Nerve Protector (K232029) | Alafair Biosciences, Inc. | 2023-11-02 |
| ATEC Posterior Navigated Disc Prep Instruments (K232345) | Alphatec Spine, Inc. | 2023-11-02 |
| VRNT (K230814) | Cognifisense, Inc. | 2023-10-31 |
| NextAR™ TSA Platform (K232280) | Medacta International S.A. | 2023-10-29 |
| ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (K233292) | Inomed Medizintechnik GmbH | 2023-10-27 |
| CoreLink Robotic Navigation Instruments (K231494) | Corelink, LLC | 2023-10-27 |
| Modius Sleep (K230826) | Neurovalens , Ltd. | 2023-10-27 |
| Aurora Surgiscope System (K232618) | Rebound Therapeutics Corporation | 2023-10-27 |
| cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) (K233170) | AtriCure, Inc. | 2023-10-26 |
| Penumbra LP Coil System (K230284) | Penumbra, Inc. | 2023-10-25 |
| Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro (K232235) | The Magstim Company , Ltd. | 2023-10-25 |
| pRESET LITE Thrombectomy Device (K231539) | Phenox Limited | 2023-10-21 |
| StealthStation Cranial Software, v3.1.5 (9735585) (K231976) | Medtronic Navigation, Inc. | 2023-10-19 |
| C.C. Life 21 (K230459) | 21 Equipment S.R.L. | 2023-10-19 |
| IRRAflow Active Fluid Exchange System (AFES) (K231664) | Irras USA, Inc. | 2023-10-19 |
| Neuroblade System (K230125) | Clearmind Biomedical | 2023-10-13 |
| 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) (K231708) | Axogen Corporation | 2023-10-12 |
| MONTAGE-QS Settable, Resorbable Bone Putty (K231475) | Orthocon, Inc. | 2023-10-12 |
| TMINI™ Miniature Robotic System (K232802) | THINK Surgical, Inc. | 2023-10-12 |
| Vlab (K230148) | Dormotech Medical, Ltd. | 2023-10-11 |
| Invictus Robotic Navigation Instruments (K232044) | Alphatec Spine, Inc. | 2023-10-06 |
| Heating Tens, FT-615 (K232675) | Hivox Biotek, Inc. | 2023-10-05 |
| TriALTIS Navigation Enabled Instruments (K231527) | Medos International Sàrl | 2023-09-29 |
| Smileyscope System (Therapy Mode) (K230825) | Smileyscope Holding, Inc. | 2023-09-25 |
| QEVO System (K232159) | Carl Zeiss Meditec, AG | 2023-09-21 |