| ULTRASOUND SYSTEM SONIMAGE HS 1 (K152577) | Konica Minolta, Inc. | 2015-10-08 |
| STERISPINE PS (K151921) | Safe Orthopaedics | 2015-10-08 |
| Salem Sump Dual Lumen Stomach Tube with Multi-functional Port (K150711) | Covidien | 2015-10-08 |
| Etest Ceftaroline (0.002 - 32ug/ml) (K151873) | Biomerieux S.A. | 2015-10-07 |
| DEXIS Webview (K151941) | Imaging Sciences International /Gendex/Dexis | 2015-10-07 |
| Inclusive Titanium Abutments compatible with: Hiossen HG Implant System (K151375) | Prismatik Dentalcraft, Inc. | 2015-10-07 |
| Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit Large (K151261) | Medela AG | 2015-10-07 |
| ARIES System (K151917) | Luminex Corporation | 2015-10-06 |
| ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System (K152369) | Siemens Medical Solutions USA, Inc. Ultrasound Group | 2015-10-06 |
| NuBrilliance Light Pain Therapy (K150554) | Wellquest International, Inc. | 2015-10-06 |
| AXIOS Stent and Delivery System (K152572) | Boston Scientific Corporation | 2015-10-06 |
| Physica CR Knee System (K151266) | Lima Corporate S.P.A. | 2015-10-06 |
| Comet Pressure Guidewire (K151610) | Boston Scientific Corporation | 2015-10-06 |
| ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD) (K151906) | Luminex Corporation | 2015-10-06 |
| Arcos One-piece Femoral Revision System (K151603) | Biomet, Inc. | 2015-10-06 |
| Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine Loop Anchor, PanaLok RC Lop Anchor, BioKnotless Anchor, BioKnotless RC Anchor, RC Loop Anc (K150209) | Depuy Mitek, A Johnson and Johnson Company | 2015-10-06 |
| iLab Polaris Multi-Modality Guidance System (K151613) | Boston Scientific Corporation | 2015-10-06 |
| Inion Spinal Graft Containment System (K151360) | Inion OY | 2015-10-06 |
| Ultraviolet Sunlamps (K151841) | Wolff System Technology Corp. | 2015-10-05 |
| STERISPINE PS (K151747) | Safe Orthopaedics | 2015-10-05 |
| Ultrasound Scanner System BK2300 (K151910) | Bk Medical Aps | 2015-10-05 |
| AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) (K152025) | Assure Tech. Co., Ltd. | 2015-10-05 |
| ADX6000 Portable X-Ray System; iRayA6 (K143494) | Dexcowin Co., Ltd. | 2015-10-05 |
| CygneX I System (K143560) | Accuthera, Inc. | 2015-10-05 |
| Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) (K151500) | Custom Orthopaedic Solutions | 2015-10-05 |
| Valeo Spacer System and Valeo II Interbody Fusion Device System (K143518) | Amedica Corp. | 2015-10-02 |
| LOSPA IS Spinal System (K151408) | Corentec Co., Ltd. | 2015-10-02 |
| CorPath 200 System (K150892) | Corindus, Inc. | 2015-10-02 |
| One Step hCG Pregnancy Test (K150063) | Coretests, Inc. | 2015-10-02 |
| iSy Implant System (K151599) | Altatec GmbH | 2015-10-02 |
| Extended Range Shifter for PROBEAT-V (K152207) | Hitachi, Ltd., Health Care Company | 2015-10-02 |
| zensor system (K151027) | Intelesens Limited | 2015-10-02 |
| GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE MONITORING SYSTEM (K141656) | Philosys, Inc. | 2015-10-02 |
| DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems (K152545) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-10-02 |
| TiTHON Staple with OsseoTi Technology (K151615) | Biomet Manufacturing Corp | 2015-10-02 |
| ARGOS (K150754) | Santec Corporation | 2015-10-02 |
| OrthoVis Web Portal (K151501) | Custom Orthopaedic Solutions, Inc. | 2015-10-02 |
| Elecsys Progesterone III CalSet (K152526) | Roche Diagnostics | 2015-10-02 |
| SICAT OPTIMOTION (K143655) | Sicat GmbH & Co. KG | 2015-10-02 |
| Synergy ODM (K151952) | Topcon Medical Systems, Inc. | 2015-10-01 |
| hemoFISH Masterpanel (K150031) | Miacom Diagnostics GmbH | 2015-10-01 |
| EPX-4440HD and EPX-4400HD with FICE (K150221) | Fujifilm Medical System U.S.A., Inc. | 2015-10-01 |
| VISERA 4K UHD SYSTEM (K151011) | Olympus Medical Systems Corp. | 2015-10-01 |
| SonoStik IV Guide Wire Introducer (K152177) | Sonostik, LLC | 2015-10-01 |
| Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants (K143515) | Prismatik Dentalcraft, Inc. | 2015-10-01 |
| JBAIDS Influenza A & B Detection Kit (K152523) | U.S Army Medical Materiel Development Activity | 2015-10-01 |
| 3M Comply Hydrogen Peroxide Indicator Tape 1228 (K150694) | 3M Company | 2015-10-01 |
| SIS Inguinal Hernia Repair Graft (K142887) | Cook Biotech Incorprated | 2015-10-01 |
| FreeStyle Precision Neo Blood Glucose Monitoring System (K142928) | Abbott Diabetes Care, Inc. | 2015-09-30 |
| Seneka I Polyscrew Pedicle Fixation System (K151849) | Senecka Spine | 2015-09-30 |
| Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set (K152524) | Cook Incorporated | 2015-09-30 |
| Supria Whole-body X-ray CT System (K150565) | Hitachi Medical Systems America, Inc. | 2015-09-30 |
| GPC Intramedullary Nailing Systems (K143245) | Gpc Medical Limited | 2015-09-30 |
| Ready-Fit (K151149) | Den Tek Oral Care, Inc. | 2015-09-30 |
| MultiScan G-Arm System (K151280) | Beijing East Whale Imaging Technology Co., Ltd. | 2015-09-30 |
| SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set (K140827) | Sd Biosensor, Inc. | 2015-09-30 |
| Q2 Intravenous Adminstration Sets and Extension Sets (K151079) | Quest Medical, Inc. | 2015-09-30 |
| PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application) (K150078) | Smartmissimo Technologies Pte, Ltd. | 2015-09-30 |
| SureSigns VS3, SureSigns VS4 (K151761) | Phillips Medical Systems | 2015-09-29 |
| HEARTWAY Power Mobility Scooter (K150998) | Heartway Medical Products Co., Ltd. | 2015-09-29 |
| U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System (K151100) | Taidoc Technology Corporation | 2015-09-29 |
| Neon EEG (K151576) | Incereb, Ltd. | 2015-09-29 |
| LOGIQ S8 (K152195) | GE Healthcare | 2015-09-29 |
| 3M Comply Hydrogen Peroxide Chemical Indicator 1248 (K150622) | 3M Company | 2015-09-29 |
| Intradermal Adapter (K151777) | West Pharmaceutical Services, Inc. | 2015-09-29 |
| MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit (K151579) | Siemens Medical Solutions USA, Inc. | 2015-09-29 |
| Cholesterol (K150654) | Randox Laboratories, Ltd. | 2015-09-29 |
| EarLens Contact Hearing Device (DEN150002) | Earlens Corporation | 2015-09-29 |
| Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series (K152483) | Grandway Technology (Shenzhen) Limited | 2015-09-29 |
| Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 (K152171) | Orthofix Srl | 2015-09-28 |
| ARIX Ankle System (K152158) | Jeil Medical Corporation | 2015-09-28 |
| Onrad Treatment System (K152488) | Accuray Incorporated | 2015-09-28 |
| Alere Afinion HbA1c, Alere Afinion AS100 Analyzer (K151809) | Alere Technologies AS | 2015-09-25 |
| Bluefin Interbody System (K143479) | Tides Medical | 2015-09-25 |
| Endoluminal Occlusion System-EOS (K150402) | Artventive Medical Group, Inc. | 2015-09-25 |
| U2 Total Knee System- Additional Sizes (K150829) | United Orthopedic Corporation | 2015-09-25 |
| BiowaveHOME Neuromodulation Pain Therapy Device (K152437) | Biowave Corporation | 2015-09-25 |
| X-spine Pedicle Screw System (K152132) | X-Spine Systems, Inc. | 2015-09-25 |
| AZUR CX Detachable 35 Coils (K151358) | MicroVention, Inc. | 2015-09-25 |
| DePuy Actis Duofox Hip Prosthesis (K150862) | DePuy Orthopaedics, Inc. | 2015-09-25 |
| Renovis Anterior Cervical Plate System (K152193) | Renovis Surgical Technologies, Inc. | 2015-09-25 |
| U2 Femoral Component, CR, Porous Coated, Additional Sizes (K150832) | United Orthopedic Corporation | 2015-09-25 |
| NuVasive X-CORE Mini Cervical Expandable VBR System (K151651) | Nu Vasive, Incorporated | 2015-09-25 |
| Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC (K152409) | Navilyst Medical, Inc. | 2015-09-24 |
| VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 (K152433) | Ortho Clinical Diagnostics | 2015-09-24 |
| SudoC (K152216) | Ld Technology, LLC | 2015-09-24 |
| iHealth BP3L Wireless Blood Pressure Monitor (K152003) | Andon Health Co, Ltd. | 2015-09-24 |
| Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet (K151786) | Roche Diagnostics | 2015-09-24 |
| U & U Intravascular Administration Set (K151151) | U&U Medical Technology Co, Ltd. | 2015-09-24 |
| Pyrenees Cervical Plate System (K152281) | K2m | 2015-09-24 |
| neon3 (K150650) | Ulrich GmbH & Co. KG | 2015-09-24 |
| Gemmed pedicle screw spinal system (K151592) | Suzhou Gemmed Medical Instrument Co., Ltd. | 2015-09-24 |
| Astringedent Clear (K152064) | Ultradent Products, Inc. | 2015-09-24 |
| Metacross OTW PTA Balloon Dilatation Catheter (K152080) | KANEKA Corporation | 2015-09-24 |
| Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis (K151293) | Tornier S.A.S. | 2015-09-24 |
| Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter (K152069) | Navilyst Medical, Inc. | 2015-09-24 |
| Solea (K151306) | Convergent Dental, Inc. | 2015-09-23 |
| UPT Series Medical RO Water System (K151637) | Specialty Water Technologies | 2015-09-23 |
| Stretta Catheter (K152317) | Mederi Therapeutics, Inc. | 2015-09-23 |
| Infinity Delta, Infinity Delta XL, Infinity Kappa (K152407) | Draeger Medical Sytems, Inc. | 2015-09-23 |