| Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm (DEN150049) | Concentric Medical, Inc. | 2016-09-02 |
| HydroCoil Embolic System (HES) (K161367) | MicroVention, Inc. | 2016-08-31 |
| MicroPlex Coil System (MCS) - HyperSoft 3D (K161452) | MicroVention, Inc. | 2016-08-31 |
| LCCS Disposable RF Electrode, LCCS Reusable RF Electrode (K152642) | Lccs Products Limited | 2016-08-26 |
| Freedom Spinal Cord Stimulator System (K160600) | Stimwave Technologies Incorporated | 2016-08-26 |
| sTMS mini (K161663) | Eneura, Inc. | 2016-08-23 |
| ImPACT Computerized Neurocognitive Concussion Management Aid (DEN150037) | Impact Applications, Inc. | 2016-08-22 |
| Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit (K153347) | Codman & Shurtleff, Inc. | 2016-08-19 |
| Adhesive Electrodes (K160138) | Gmdasz Manufacturing Co., Ltd. | 2016-08-11 |
| Cerafix Dura Substitute (K161278) | Acera Surgical, Inc. | 2016-08-08 |
| Fehling-Punches (K153243) | Fehling Instruments GmbH & Co. KG | 2016-08-04 |
| Nautilus BrainPulse 1000 (DEN140040) | Jan Medical, Inc. | 2016-08-01 |
| HANAROCare ReJu (K160893) | M.I.Tech Co., Ltd. | 2016-07-27 |
| Precision Screw (K160385) | Cryptych Pty, Ltd. | 2016-07-27 |
| Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs (K161154) | Spr Therapeutics, LLC | 2016-07-23 |
| ELAN 4 Motor System (K152960) | Aesculap, Inc. | 2016-07-22 |
| St. Louis Band (K161138) | Orthomerica Products, Inc. | 2016-07-20 |
| EPIC ClearView System (DEN150004) | Epic Research & Diagnostics, Inc. | 2016-07-15 |
| PMT Platinum Depthalon Depth Electrode (K151790) | Pmt Corporation | 2016-07-14 |
| EXACTECH GPS (K152764) | Blue Ortho | 2016-07-13 |
| INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set (K153272) | Relievant Medsystems | 2016-07-09 |
| Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments (K153700) | Aesculap Implant Systems, LLC | 2016-07-08 |
| Styrker OrthoMap Express Knee System (K153240) | Stryker Corporate | 2016-07-07 |
| BrightMatter Guide with BrightMatter Pointer (K160523) | Synaptive Medical, Inc. | 2016-06-24 |
| SANDMAN ELITE (K153353) | Embla Systems | 2016-06-23 |
| NERBRIDGE (K152967) | Toyobo Co., Ltd. | 2016-06-22 |
| Target Detachable Coils (K161429) | Stryker Neurovascular | 2016-06-22 |
| Kerrison Rongeurs (K152734) | Vitalitec Medizintechnik GmbH | 2016-06-18 |
| Cranial COVER (K160739) | Neos Surgery S.L | 2016-06-12 |
| NeuroStar TMS Therapy System (K160703) | Neuronetics, Inc. | 2016-06-10 |
| Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover (K152342) | St Jude Medical | 2016-06-09 |
| Background Pattern Classification [BPc(TM)] (K152301) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2016-06-03 |
| Strive (K153704) | Djo, LLC | 2016-06-03 |
| Heat Pain Pro (K160115) | Omron Healthcare, Inc. | 2016-06-03 |
| Stealth-Midas System (K160713) | Medtronic Powered Surgical Solutions | 2016-05-26 |
| ActTrust (K151784) | Condor Instruments Ltda. - Epp | 2016-05-25 |
| CUR Model 1 (K160052) | Thimble Bioelectronics, Inc. | 2016-05-20 |
| Navio (K160537) | Blue Belt Technologies, Inc. | 2016-05-19 |
| Target Detachable Coils (K153658) | Stryker Neurovascular | 2016-05-19 |
| Aesculap OrthoPilot Next Generation (K153396) | Aesculap Implant Systems, LLC | 2016-05-16 |
| MagPro R20 (K160280) | Tonica Elektronik A/S | 2016-05-16 |
| Cereve Sleep System (DEN140032) | Cereve, Inc. | 2016-05-13 |
| Electronic Pulse Stimulator (K153520) | Jkh Health Co., Ltd. | 2016-05-05 |
| Alphatec Navigation Instruments (K153603) | Alphatec Spine, Inc. | 2016-04-29 |
| ISEN-Goggles (K152727) | Isen Tech & Trading Company, Ltd. | 2016-04-26 |
| Penumbra Smart Coil (K160832) | Penumbra, Inc. | 2016-04-20 |
| VERASENSE Knee System (K150372) | Orthosensor, Inc. | 2016-04-15 |
| MagView BIOMAGNETOMETER SYSTEM (K152184) | Tristan Technologies, Inc. | 2016-04-08 |
| VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter (K160223) | Cook Incorporated | 2016-04-08 |
| StrataMR Valves and Shunts (K152700) | Medtronic Neurosurgery | 2016-04-07 |
| EM ENT Navigated Suctions (K153555) | Medtronic Navigation, Inc. | 2016-04-07 |
| ReGrasp (K153163) | Rehabtronics, Inc. | 2016-04-07 |
| Fiagon Navigation System (K151156) | Fiagon GmbH | 2016-04-01 |
| BrightMatter Guide with Surface Trace Registration (K153281) | Synaptive Medical, Inc. | 2016-03-30 |
| MRII Cranial Drill and Accessories (K160129) | Mri Interventions, Inc. | 2016-03-26 |
| PointerShell Universal, PointerShell LS (K160479) | Fiagon GmbH | 2016-03-23 |
| RejuvatoneMD (K152199) | Trophy Skin, Inc. | 2016-03-23 |
| Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes (K153019) | Bio Protech, Inc. | 2016-03-21 |
| Apollo System (K152699) | Penumbra, Inc. | 2016-03-17 |
| ClearPoint System (K160434) | Mri Interventions, Inc. | 2016-03-17 |
| Cerafix Dura Substitute (K153613) | Acera Surgical, Inc. | 2016-03-16 |
| DReal (K153519) | Carevature Medical, Ltd. | 2016-03-16 |
| Sleep Profiler (K153412) | Advanced Brain Monitoring, Inc. | 2016-03-14 |
| Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling (K153041) | Integra LifeSciences Corporation | 2016-03-14 |
| StimQ Peripheral Nerve Stimulator (PNS) System (K152178) | Stimq, LLC | 2016-03-11 |
| PEEK Customized Cranial Implant (K153248) | Stryker | 2016-03-10 |
| GuideWire (K160369) | Fiagon GmbH | 2016-03-10 |
| Mailuokang Self-adhesive Electrode (K152815) | Shenzhen Mailuokang Technology Co., Ltd. | 2016-03-08 |
| Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory (K152897) | Integra LifeSciences Corporation | 2016-03-04 |
| Cefaly (K160237) | Cefaly Technology | 2016-03-04 |
| DNAP Electrode (K152547) | Ad-Tech Medical Instrument Corporation | 2016-03-04 |
| Leksell Stereotactic System, Injection/ Aspiration Needle Kit (K152558) | Elekta Instrument AB | 2016-03-02 |
| OrthAlign Plus System (K153237) | Orthalign, Inc. | 2016-03-01 |
| Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs (K150468) | K2 Medical GmbH & Co. KG | 2016-02-29 |
| InZone Detachment System (K160096) | Stryker Neurovascular | 2016-02-19 |
| Fusion Compact Navigation System (K153247) | Medtronic Navigation, Inc. | 2016-02-18 |
| Ennova Self-adhesive Electrode (K152648) | Suzhou Ennova Electronics Technology Co.,Ltd | 2016-02-18 |
| TSolution One w/ACG+ Surgical System (K153647) | THINK Surgical, Inc. | 2016-02-16 |
| Pain Therapy System, Model PTS-II (K150277) | Counter Scientific Development (Gz), Ltd. | 2016-02-12 |
| Nutra Face Lift Model PE8050 (K150826) | Nutra Luxe MD, LLC | 2016-02-10 |
| Navigation Instruments (K153203) | Globus Medical, Inc. | 2016-02-03 |
| EYE-SYNC (K152915) | Syncthink, Inc. | 2016-01-29 |
| Cervello STIM (K151354) | Blackrock Neuromed | 2016-01-27 |
| Discovery 24 (K150498) | Brainmaster Technologies, Inc. | 2016-01-26 |
| FD TENS 2090, FD TENS 2095 (K152676) | Fuji Dynamics , Ltd. | 2016-01-22 |
| DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables (K152670) | Medos International SARL | 2016-01-22 |
| MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) (K153594) | MicroVention, Inc. | 2016-01-22 |
| LL TENS 160A, LL TENS 160B (K152374) | Fuji Dynamics , Ltd. | 2016-01-13 |
| Nerve Capping Device (K152684) | Polyganics Innovations BV | 2016-01-13 |
| Quell (K152954) | Neurometrix, Inc. | 2016-01-05 |
| ROSA Spine (K151511) | Medtech S.A | 2016-01-04 |
| VisualEyes (K152112) | Interacoustics A/S | 2015-12-29 |
| Intellijoint HIP(tm) System (K151364) | Intellijoint Surgical, Inc. | 2015-12-28 |
| 2-in-1 Abdominal Muscle Training & Back Pain Relief System (K152128) | Tohkai Precision Electrical Manufactory (Shenzhen) Limited | 2015-12-23 |
| ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) (K152852) | Bayer Healthcare, LLC | 2015-12-22 |
| Pacifier Activated Lullaby (PAL®) (K151050) | Power Medical Devices, LLC | 2015-12-22 |
| LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm (K150898) | Moller Medical GmbH | 2015-12-18 |
| ROSA Brain (K151359) | Medtech S.A | 2015-12-18 |
| Counter OTC TENS Device, Model CSD-737Z (K151279) | Counter Scientific Development (Gz), Ltd. | 2015-12-16 |
| Reaxon Plus (K143711) | Medovent GmbH | 2015-12-02 |