| gammaCore Sapphire (K191830) | Electrocore, Inc. | 2020-03-26 |
| Becker External Drainage and Monitoring System (K200456) | Medtronic, Inc. | 2020-03-26 |
| TruDi Probe (K193453) | Acclarent, Inc. | 2020-03-23 |
| Somryst (K191716) | Pear Therapeutics, Inc. | 2020-03-23 |
| NeuralScan System (K192753) | Medeia, Inc. | 2020-03-17 |
| Health Expert Electronic Stimulator (model: AST-300L) (K190783) | Shenzhen Osto Technology Company Limited | 2020-03-14 |
| NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate (K192162) | Neurovention, LLC | 2020-03-13 |
| FlexPointer 1.5 Single Use, FlexTube 3 Single Use (K200041) | Fiagon GmbH | 2020-03-10 |
| L100 Go System (K200262) | Bioness, Inc. | 2020-03-04 |
| Coolief Radiofrequency Generator (CRG) System (K192491) | Avanos Medical, Inc. | 2020-02-21 |
| TGS Guidewire and updated Scopis Software (K193118) | Stryker Ent | 2020-02-21 |
| DORO LUCENT® iXI and iMRI Headrest System (K191740) | Pro Med Instruments GmbH | 2020-02-21 |
| ApneaTrak (K192624) | Cadwell Industries, Inc. | 2020-02-20 |
| Orion LifeSpan MEG (K191785) | Compumedics Limited | 2020-02-14 |
| Real Intelligence Cori (K193120) | Blue Belt Technologies, Inc. | 2020-02-14 |
| Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) (K191346) | Blackrock Microsystems | 2020-02-14 |
| TGS Universal Headrest with Mounting Arm (K193502) | Stryker Ent | 2020-02-14 |
| ClearPoint System and Accessories (K200079) | Mri Interventions, Inc. | 2020-02-13 |
| Vesta RF Cannula (K190259) | Biomerics | 2020-02-07 |
| Elefix V Paste for EEG & EMG (K191975) | Nihon Kohden Corporation | 2020-02-07 |
| Trevo NXT ProVue Retriever (K200117) | Stryker | 2020-02-07 |
| Mako Total Hip Application (K193128) | Mako Surgical Corp. | 2020-02-02 |
| Optima Coil System (K200030) | Balt USA, LLC | 2020-02-01 |
| TruDi Navigation System (K192397) | Biosense Webster | 2020-01-30 |
| Neo (K192889) | Eemagine Medical Imaging Solutions GmbH | 2020-01-30 |
| Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode (K191186) | Ad-Tech Medical Instrument Corporation | 2020-01-25 |
| LCCS VC-S RF Cannula (K191293) | Lccs Products Limited | 2020-01-24 |
| cortiQ PRO (K191432) | G.Tec Medical Engineering GmbH | 2020-01-24 |
| E-EEGX, N-EEGX (K191322) | GE Healthcare Finland Oy | 2020-01-22 |
| Disposable Gold Cup EEG Electrodes (K192564) | Dymedix Diagnostics, Inc. | 2020-01-21 |
| SAC2 - Electrode Cream (K192606) | Spes Medica Srl | 2020-01-17 |
| CustomizedBone Service (K193547) | Fin-Ceramica Faenza S.P.A. | 2020-01-17 |
| Black Diamond Navigation Instruments (K192495) | Osseus Fusion Systems | 2020-01-17 |
| Longeviti ClearFit Cranial Implant (K191210) | Longeviti Neuro Solutions, LLC | 2020-01-09 |
| Sterile LeadConfirm (K191739) | Alpha Omega Engineering , Ltd. | 2020-01-02 |
| xvision Spine system (XVS) (K190929) | Augmedics, Ltd. | 2019-12-20 |
| Everyway OTC TENS/EMS Combination (K192589) | Everyway Medical Instruments Co.,Ltd | 2019-12-19 |
| Spinal Elements Navigated Instruments (K190881) | Spinal Elements, Inc. | 2019-12-19 |
| CNS Envision (K192572) | Moberg Research, Inc. | 2019-12-17 |
| Corelink Navigation Instruments (K182731) | Corelink, LLC | 2019-12-13 |
| Health Expert Electronic Stimulator (K190673) | Shenzhen Osto Technology Company Limited | 2019-12-12 |
| TSolution One Total Knee Application (K193135) | THINK Surgical, Inc. | 2019-12-11 |
| EyeStat (K191700) | Blinktbi, Inc. | 2019-12-09 |
| ALLIVE (K192773) | Nu Eyne Co., Ltd. | 2019-12-06 |
| Aurora Surgiscope System (K191861) | Rebound Therapeutics | 2019-12-06 |
| Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) (K190009) | Hong Qiangxing (Shenzhen) Electronics Limited | 2019-12-02 |
| Vital Navigation System (K191722) | Zimmer Biomet Spine, Inc. | 2019-12-02 |
| I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph (K192186) | Neurolign USA, LLC | 2019-11-29 |
| Optimus NEURO System - Sterile Kit (K190811) | Osteonic Co., Ltd. | 2019-11-27 |
| 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application (K192945) | 7D Surgical, Inc. | 2019-11-27 |
| NeuroOne Cortical Electrode (K192764) | Neuroone, Inc. | 2019-11-26 |
| Cadwell Bolt Software (K190760) | Cadwell Industries, Inc. | 2019-11-23 |
| Healy (K191075) | Timewaver Production GmbH | 2019-11-22 |
| Trevo NXT ProVue Retriever (K192207) | Stryker | 2019-11-22 |
| Spes Medica Subdermal Needle Electrodes (K192603) | Spes Medica Srl | 2019-11-22 |
| Navigated Anterolateral Disc Prep Instruments (K192336) | Medtronic Sofamor Danek USA, Inc. | 2019-11-22 |
| M. Blue Adjustable Shunt System (K192266) | Aesculap, Inc. | 2019-11-21 |
| Penumbra LP Coil System (K192955) | Penumbra, Inc. | 2019-11-20 |
| Arcus Head Fixation Frame (K191701) | Mri Interventions, Inc. | 2019-11-15 |
| IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit (K192289) | Irras USA, Ltd. | 2019-11-15 |
| Brainlab Compatible K2M Navigation Instruments (K192911) | K2m, Inc. | 2019-11-14 |
| Nox Sleep System (K192469) | Nox Medical | 2019-11-13 |
| SandShark Injectable Anchor (SIA) System (K191466) | Stimwave Technologies, Inc. | 2019-11-07 |
| 7D Surgical System (K192140) | 7D Surgical, Inc. | 2019-11-05 |
| iASSIST Knee System (K192080) | Orthosoft Inc (D/B/A Zimmer Cas) | 2019-11-05 |
| Stealth Autoguide System, Midas Rex Legend Depth Stop System (K191597) | Medtronic Navigation, Inc. | 2019-11-01 |
| Combo Electrotherapy Device (K192087) | Shenzhen Roundwhale Technology Co. , Ltd. | 2019-11-01 |
| StimRouter Neuromodulation System (K190047) | Bioness, Inc. | 2019-10-31 |
| ROSA ONE Spine application (K192173) | Medtech S.A | 2019-10-29 |
| Zimmer Biomet Universal Navigation System (K192133) | Zimmer Biomet Spine, Inc. | 2019-10-29 |
| Zimmer Biomet Universal Navigation System (K190556) | Zimmer Biomet Spine, Inc. | 2019-10-24 |
| DORO QR3 XTom Headholder System (K191979) | Pro Med Instruments GmbH | 2019-10-22 |
| SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set (K191943) | Medos International SARL | 2019-10-18 |
| BcSs-PICNI-2000 Sensor (K182073) | Braincare Desenvolvimento E Inovacao Tecnologica S.A. | 2019-10-17 |
| NuFACE Mini Device (K191672) | Carol Cole Company Dba Nuface | 2019-10-15 |
| MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System (K191684) | Integra LifeSciences Corporation | 2019-10-11 |
| Electronic Pulse Stimulator (K183674) | Shenzhen Leading Perfection Technology Co., Ltd. | 2019-10-11 |
| Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) (K182136) | Shenzhen Osto Technology Co., Ltd. | 2019-10-10 |
| Spine Wave Navigated Instruments (K192526) | Spine Wave, Inc. | 2019-10-10 |
| Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial (K190523) | Ossdsign AB | 2019-10-10 |
| TSolution One Total Knee Application (K191369) | THINK Surgical, Inc. | 2019-10-08 |
| Premia Spine XL Instruments (K191854) | Premia Spine, Ltd. | 2019-10-08 |
| Intellijoint® Navigation System (K191507) | Intellijoint Surgical, Inc. | 2019-10-01 |
| Precision Spine Navigation Instrumentation (K181606) | Precision Spine, Inc. | 2019-09-27 |
| Mediracer NCS (K190536) | Mediracer OY | 2019-09-25 |
| Mako Total Hip Application, Mako Total Knee Application (K191998) | Mako Surgical Corp. | 2019-09-24 |
| Medi-Direct TENS Pen (K182671) | Jkh USA, LLC | 2019-09-21 |
| INTAI Surgery Navigation System (K180523) | Intai Technology Corporation | 2019-09-20 |
| L360 Thigh System (K191587) | Bioness, Inc. | 2019-09-12 |
| Ceribell Pocket EEG Device (K191301) | Ceribell, Inc. | 2019-09-11 |
| BrainScope TBI (K190815) | Brainscope Company, Inc. | 2019-09-11 |
| Focus TENS Therapy, Model PM710-M/-L (K183215) | Omron Healthcare, Inc. | 2019-09-07 |
| Microscope Navigation (K190250) | Brainlab AG | 2019-09-06 |
| IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 (K191435) | Nalu Medical, Inc. | 2019-09-06 |
| Myo Plus (K191179) | Otto Bock Healthcare Products GmbH | 2019-09-04 |
| Artemis Eye System (K190719) | Penumbra, Inc. | 2019-08-30 |
| ReliefBand (K191547) | Reliefband Technologies, LLC | 2019-08-30 |
| Spine & Trauma Navigation (K183605) | Brainlab AG | 2019-08-29 |
| PureLift (K190269) | Xtreem Pulse, LLC | 2019-08-28 |
| Navigated T2 STRATOSPHERE Inserters and Navigated Templates (K191039) | Medtronic Sofamor Danek USA, Inc. | 2019-08-26 |