| SonicLift (K150077) | Pretika Corporation | 2015-11-25 |
| PainKARE (K151034) | Triowave Technologies | 2015-11-21 |
| Collagen Dural Regeneration Matrix (K150825) | Collagen Matrix, Inc. | 2015-11-20 |
| BioArchitects Patient Specific Cranial/Craniofacial Plate (K151692) | Bioarchitects USA, LLC | 2015-11-20 |
| Renaissance X System (K152041) | Mazor Robotics , Ltd. | 2015-11-17 |
| ICS Impulse (K151504) | Gn Otometrics | 2015-11-16 |
| Entropy Module, E-ENTROPY-01 (K150298) | Ge Healthcare Filand OY | 2015-11-12 |
| Patient Contoured Implant-PEEK (PCI-PEEK) (K151382) | KLS Martin L.P. | 2015-11-09 |
| IdentEvent (K150688) | Optima Neuroscience, Inc. | 2015-11-05 |
| Tyece OTC TENS Device (K150386) | Tyece , Ltd. | 2015-11-05 |
| DURAFORM Dural Graft Implant (K152481) | Codman & Shurtleff, Inc. | 2015-10-30 |
| X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) (K152040) | Advanced Brain Monitoring, Inc. | 2015-10-30 |
| SYMBIS Surgical System (K143420) | Imris, Inc. | 2015-10-30 |
| Codman Certas Plus Programmable Valve (K152152) | Medos International SARL | 2015-10-27 |
| ICS CHARTR EP 200 WITH VEMP (K143670) | Gn Otometrics A/S | 2015-10-23 |
| R-40 EEG Amplifier (K151600) | Lifelines , Ltd. | 2015-10-23 |
| TSolution One w/ACG surgical System (K150741) | THINK Surgical, Inc. | 2015-10-22 |
| ClearPoint System (K142505) | Mri Interventions, Inc. | 2015-10-21 |
| Palm TENS (K150308) | Heat IN A Click, LLC | 2015-10-20 |
| Navio (K152574) | Blue Belt Technologies, Inc. | 2015-10-20 |
| QBioScan (K150804) | Medeia, Inc. | 2015-10-19 |
| EV-820 OTC Pain Relief TENS (K151479) | Everyway Medical Instruments Co.,Ltd | 2015-10-16 |
| Dr-Ho's Foot Pad Electrode (K151693) | Drtv Asia, Ltd. | 2015-10-09 |
| Neon EEG (K151576) | Incereb, Ltd. | 2015-09-29 |
| BiowaveHOME Neuromodulation Pain Therapy Device (K152437) | Biowave Corporation | 2015-09-25 |
| SudoC (K152216) | Ld Technology, LLC | 2015-09-24 |
| STARband, STARlight (K151979) | Orthomerica Products, Inc. | 2015-09-18 |
| Partial Knee Application (PKA) (K142530) | Mako Surgical Corporation | 2015-09-16 |
| NFANT Feeding Solution (K143507) | Nfant Labs, LLC | 2015-09-09 |
| Navigated XIA 4.5 Polyaxial Screwdriver (K143597) | Stryker Corporate | 2015-09-04 |
| DirectInject (K143661) | Stryker | 2015-09-02 |
| ANAM Test System: Military Battery (K150154) | Vista Lifesciences, Inc. | 2015-08-28 |
| RxG Distraction System (K150771) | KLS Martin L.P. | 2015-08-27 |
| PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority (K152076) | Stryker | 2015-08-26 |
| Zekang Self-adhesive Electrode (K150971) | Jiangsu Zekang Medical Technology Co., Ltd. | 2015-08-25 |
| Lifelines iEEG (K143487) | Kvikna Ehf | 2015-08-21 |
| STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast (K150220) | Eb Neuro S.P.A. | 2015-08-19 |
| Transcutaneous Electrical Nerve Stimulators (TENS) (K150043) | Andon Health Co, Ltd. | 2015-08-14 |
| Mitsar-EEG (K143233) | Mitsar Co., Ltd. | 2015-08-13 |
| PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE (K151929) | Persyst Development Corporation | 2015-08-12 |
| Total Knee Application (TKA) (K143752) | Mako Surgical Corp. | 2015-08-06 |
| MagVita TMS Therapy System (K150641) | Tonica Elektronik A/S | 2015-07-31 |
| Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH (K150371) | Diros Technology, Inc. | 2015-07-30 |
| Philips Self-Adhesive Electrodes (K151033) | Philips Consumer Lifestyle | 2015-07-28 |
| Axium Detachable Coil System (K151447) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2015-07-28 |
| A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device (K150924) | Anchor Innovation Medical (A.I.M.) | 2015-07-27 |
| Barricade Embolization Coil System (K151760) | Blockade Medical | 2015-07-27 |
| PulseRelief (K151035) | Philips Consumer Lifestyle | 2015-07-21 |
| TENS AND POWERED MUSCLE STIMULATOR (K143268) | Shenzhen As-Tec Technology Co., Ltd. | 2015-07-21 |
| Penumbra Smart Coil (K151572) | Penumbra, Inc. | 2015-07-10 |
| NavSuite3 Kit (K150301) | Stryker Leibinger GmbH & Co. KG - Navigation | 2015-07-08 |
| I-Portal NOTC, VNG and VOG (K143607) | Neuro Kinetics, Inc. | 2015-07-08 |
| SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm (K151536) | Mri Interventions, Inc. | 2015-07-08 |
| Electronic Pulse Stimulator (K150995) | Shenzhen Jingkehui Electronic Co.., Ltd. | 2015-07-06 |
| STARband, STARlight (K151147) | Orthomerica Products, Inc. | 2015-07-01 |
| Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm (K150518) | Dupaco, Inc. | 2015-06-29 |
| Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade (K151387) | Stryker | 2015-06-24 |
| DiscoverEEG System, Model DE-401 (K142834) | Neurowave Systems, Inc. | 2015-06-23 |
| NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE (K133995) | Neurosoft , Ltd. | 2015-06-19 |
| Navigated Disc Prep Instruments and CAPSTONE Trials (K150231) | Medtronic Sofamor Danek USA, Inc. | 2015-06-16 |
| NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook (K150378) | Nico Corporation | 2015-06-12 |
| MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS (K150319) | Codman & Shurtleff, Inc. | 2015-06-12 |
| Synergy Cranial (K150216) | Medtronic Navigation, Inc. | 2015-06-11 |
| Freedom Spinal Cord Stimulator System (K150517) | Stimwave Technologies Incorporated | 2015-06-05 |
| COGNIVUE (DEN130033) | Cerebral Assessment Systems, Inc. | 2015-06-05 |
| DISPOSABLE PRE-GELLED SURFACE ELECTRODE (K142159) | Rochester Electro Medical, Inc. | 2015-06-03 |
| Everyway Facial MENS (K142794) | Everyway Medical Instruments Co.,Ltd | 2015-06-02 |
| SmartTENS (K143430) | Easy Med Instrument Co., Ltd. | 2015-05-29 |
| Synapse Transcutaneous Electrical Stimulation Device (K143198) | Synapse Electroceutical Limited | 2015-05-27 |
| Stryker Maestro Air Motors (K150801) | Stryker Corporation | 2015-05-22 |
| Scrambler Therapy MC-5 A Device (K142666) | Delta International Services & Logistics S.R.L | 2015-05-22 |
| RETeval Visual Electrodiagnostic Device (K142567) | Lkc Technologies, Inc. | 2015-05-19 |
| Brainscope Ahead 200 (K143643) | Brainscope Company, Inc. | 2015-05-15 |
| CLINISCANSM EEG (K141883) | Picofemto, LLC | 2015-05-15 |
| GEMORE OTC TENS (K150681) | Gemore Technology Co, Ltd. | 2015-05-12 |
| Rapid Therapy System (K143531) | Magstim Company Limited | 2015-05-08 |
| Stryker Footed Attachments and Cutting Accessories (K143399) | Stryker Corp. | 2015-05-08 |
| Stryker MIS Attachments and Cutting Accessories (K143540) | Stryker Corporation | 2015-05-01 |
| CAS-One Liver (K143024) | Cascination AG | 2015-04-28 |
| Neuromaster G1 MEE200 (K142624) | Nihon Kohden Corporation | 2015-04-24 |
| Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments (K143320) | Stryker Corp. | 2015-04-23 |
| STARBAND, STARLIGHT (K142141) | Orthomerica Products, Inc. | 2015-04-23 |
| Natus Quantum (K143440) | Natus Medical Incorporated | 2015-04-20 |
| Alcyone MEMS Cannula (AMC) System (K150660) | Alcyone Lifesciences, Inc. | 2015-04-16 |
| FlexPointer 1.5 mm (K150473) | Fiagon GmbH | 2015-04-16 |
| BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL (4 ELECTRODES) (K143506) | Covidien | 2015-04-16 |
| Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs (K150428) | Integra Lifesciences Corp. | 2015-04-16 |
| MDT Navigable Brain Biopsy Cannula (K143241) | Izi Medical Products, LLC | 2015-04-13 |
| BRIGHTMATTER NAVIGATION SYSTEM (K142024) | Synaptive Medical, Inc. | 2015-04-02 |
| MYGAIT STIMULATION SYSTEM (K141812) | Otto Bock Healthcare Products GmbH | 2015-04-02 |
| AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM (K141687) | Aesculap, Inc. | 2015-04-02 |
| POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX (K141227) | Sophysa SA | 2015-04-02 |
| DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) (K141385) | Depuy Synthes Companies of Johnson & Johnson | 2015-03-27 |
| STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION (K141833) | Medtronic Navigation, Inc. | 2015-03-25 |
| BioniCare Hand System (K142236) | Vision Quest Industries, Inc. | 2015-03-23 |
| DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System (K142344) | Izi Medical Products, LLC | 2015-03-20 |
| Navio (K143668) | Blue Belt Technologies, Inc. | 2015-03-20 |
| Penumbra Smart Coil (K143218) | Penumbra, Inc. | 2015-03-18 |
| Sleepware G3 (K142988) | Respironics, Inc. | 2015-03-16 |
| EASYDRILL AUTOSTOP CRANIAL PERFORATOR (K141455) | Micromar Ind. Com. , Ltd. | 2015-03-16 |