| CARESCAPE MONITOR B450 (K132533) | GE Healthcare Finland Oy | 2013-12-04 |
| MARS HOLTER ANALYSIS WORKSTATION (K132437) | Ge Medical Systems Information Technologies, Inc. | 2013-12-04 |
| S HEALTH (K132148) | Samsung Electronics Co., Ltd. | 2013-12-04 |
| VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM (K132604) | Covidien | 2013-12-04 |
| SURVEYOR CENTRAL STATION (K131929) | Mortara Instrument, Inc. | 2013-12-03 |
| REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM (K133282) | Reverse Medical Corporation | 2013-11-27 |
| INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC (K131913) | Philips Medizin Systeme Boeblingen GmbH | 2013-11-26 |
| EMOTION ECG MOBILE (K131699) | Mega Electronics , Ltd. | 2013-11-26 |
| ASPIRE RX-LP6 ASPIRATION CATHETER (K131998) | Control Medical Technology, LLC | 2013-11-26 |
| CV3000 HOLTER ANALYSIS SYSTEM (K131897) | Vales & Hills Biomedical Tech. , Ltd. | 2013-11-26 |
| INBODY (K130777) | Biospace Corporation Limited | 2013-11-25 |
| VALVED TEARAWAY INTRODUCER GENERATION II (K132498) | Medcomp (Medical Components, Inc.) | 2013-11-25 |
| BIA / VITALITY ANALYZER (K130856) | Ipgdx, LLC | 2013-11-25 |
| DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (K133399) | Cardiovascular Systems Incorporated | 2013-11-22 |
| PC ECG (K131819) | Edan Instruments, Inc. | 2013-11-22 |
| V-STICK VASCULAR ACCESS SET (K130730) | Argon Medical | 2013-11-22 |
| V8 TRANSLUMINAL BAV CATHETER (K132728) | Intervalve, Inc. | 2013-11-22 |
| SOFIA DISTAL ACCESS CATHETER (K131482) | MicroVention, Inc. | 2013-11-22 |
| VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR (K132808) | Welch Allyn, Inc. | 2013-11-20 |
| WRIGHT GRADIENT 52 - TORSO (K131387) | Wright Therapy Products, Inc. | 2013-11-20 |
| ISIRONA MAGELLAN (K130707) | Isirona, LLC | 2013-11-20 |
| AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER (K132712) | Medtronic, Inc. | 2013-11-19 |
| PARACE MD EKOSCOPE IS100 (K123148) | Parace, LLC | 2013-11-19 |
| TRANSGATE GUIDE CATHETER (K132542) | Stryker Neurovascular | 2013-11-15 |
| ND NABIL DIB INFUSION CATHETER (K130569) | Translational Research Institute | 2013-11-15 |
| INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM (K133208) | Boston Scientific Corp | 2013-11-14 |
| FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT (K131778) | Maquet Cardiovascular, LLC | 2013-11-14 |
| BOSCH BLOOD PRESSURE METER (BP5000 BT) (K131026) | Robert Bosch Healthcare Systems, Inc. | 2013-11-14 |
| DIGITAL ELECTROCARDIOGRAPHS (K131262) | Sonoscape Company Limited | 2013-11-14 |
| QUADROX-IR ADULT AND SMALL ADULT (K133265) | Maquet Cardiopulmonary, AG | 2013-11-12 |
| MEDIVALVE ACWIRE (K132545) | Medivalve , Ltd. | 2013-11-08 |
| Merit ASAPLP Aspiration Catheter (K132155) | Merit Medical Systems, Inc. | 2013-11-07 |
| LEMAITRE 8F OCCLUSION CATHETER (K132022) | LeMaitre Vascular, Inc. | 2013-11-06 |
| BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET (K132048) | Molnlycke Health Care Us, LLC | 2013-11-06 |
| CARDIOX FLOW DETECTION SYSTEM (K122400) | Cardiox Corp. | 2013-11-05 |
| LEMILLS VALVULOTOME (K132047) | LeMaitre Vascular, Inc. | 2013-11-05 |
| PETITE BASIC SYSTEM 701 ELT (K131420) | Mego Afek AC , Ltd. | 2013-11-01 |
| SILK ROAD ACCESS CATHETER (K130649) | Silk Road Medical, Inc. | 2013-11-01 |
| MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) (K132924) | Medtronic, Inc. | 2013-10-31 |
| DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO (K132995) | Medtronic, Inc. | 2013-10-31 |
| OFFROAD RE-ENTRY CATHETER SYSTEM (K131914) | Boston Scientific Corp | 2013-10-31 |
| FIRMAP CATHETER (K130827) | Topera, Inc. | 2013-10-31 |
| VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT (K132166) | Maquet Cardiopulmonary, AG | 2013-10-30 |
| MYPATCH (K131190) | Dms-Service, LLC | 2013-10-29 |
| INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES (K131446) | Integra LifeSciences Corporation | 2013-10-28 |
| AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35 (K132083) | MicroVention, Inc. | 2013-10-28 |
| AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE (K132972) | Medtronic, Inc. | 2013-10-28 |
| ITCLAMP 50 (K132651) | Innovative Trauma Care, Inc. | 2013-10-28 |
| ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER (K132020) | Cook, Inc. | 2013-10-25 |
| TRELLIS-8 PERIPHERAL INFUSION SYSTEM (K130904) | Covidien | 2013-10-25 |
| MEDUSA VASCULAR PLUG (K123696) | Endoshape, Inc. | 2013-10-25 |
| SHEATHLESS EAUCATH CORONARY GUIDE CATHETER (K132556) | Asahi Intecc Co., Ltd. | 2013-10-24 |
| AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR (K132627) | Honsun (Nantong) Co., Ltd. | 2013-10-23 |
| OPTUM TELEHEALTH APPLICATION (K130971) | Optumhealth Care Solutions, Inc. | 2013-10-23 |
| 5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER (K132673) | Medtronic, Inc. | 2013-10-22 |
| OCCLUSION BALLOON CATHETER (K132990) | Boston Scientific Corp | 2013-10-22 |
| DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS (K132947) | Boston Scientific Corp | 2013-10-18 |
| PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR (K130684) | Philips Medical Systems | 2013-10-18 |
| NBM-200MP (K124041) | Orsense, Ltd. | 2013-10-17 |
| LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFF (K130942) | Legacy Medical, Inc. | 2013-10-17 |
| INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550 (K131872) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2013-10-17 |
| STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER (K132430) | Boston Scientific Corp | 2013-10-17 |
| RESPIGUIDE DELIVERY SYSTEM (K130378) | Respicardia | 2013-10-17 |
| TVC IMAGING SYSTEM, TVC INSIGHT CATHETER (K130719) | Infraredx, Inc. | 2013-10-17 |
| FINGERTIP PULSE OXIMETER (K131047) | Beijing Choice Electronic Technololgy Co., Ltd. | 2013-10-16 |
| BRAEMAR CARDIOKEY HOLTER RECORDER (K130294) | Braemar Manufacturing, LLC | 2013-10-16 |
| MODIFIED CONCENTRIC MICROCATHETER (K131437) | Concentric Medical, Inc. | 2013-10-11 |
| REVERSE MEDICAL MICROCATHETER (K130858) | Reverse Medical Corporation | 2013-10-11 |
| AUDICOR CPAM WITH SDB (SINGLE SENSOR) (K130660) | Inovise Medical, Inc. | 2013-10-11 |
| PPA/BT-RB STETHOSCOPE (K132405) | Rnk Products, Inc. | 2013-10-11 |
| PCP-USB STETHOSCOPE (K132560) | Rnk Products, Inc. | 2013-10-11 |
| DELTEX MEDICAL CARDIOQ-EDM+ (K132139) | Deltex Medical Limited | 2013-10-10 |
| QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS (K132829) | Maquet Cardiopulmonary, AG | 2013-10-08 |
| VISI MOBILE MONITORING SYSTEM (K130709) | Sotera Wireless, Inc. | 2013-10-07 |
| HEM-6221 (K131749) | Omron Healthcare, Inc. | 2013-10-07 |
| VITAHEAT PATIENT WARMING SYSTEM (K132454) | Vitaheat Medical, LLC | 2013-10-04 |
| OCCLUSION PERFUSION CATHETER (K130525) | Advanced Catheter Therapies, Inc. | 2013-10-03 |
| FINGERTIP PULSE OXIMETER (K130947) | Beijing Choice Electronic Technololgy Co., Ltd. | 2013-10-03 |
| EMBOZENE MICROSPHERES (K132675) | Celonova Biosciences, Inc. | 2013-10-03 |
| MODIFIED FLOWGATE BALLOON GUIDE CATHETER (K131492) | Concentric Medical, Inc. | 2013-10-03 |
| PATIENT MONITOR (K123711) | Shenzhen Creative Industry Co., Ltd. | 2013-10-01 |
| MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR (K132369) | Hansen Medical, Inc. | 2013-09-27 |
| NMI COAXIAL MICROINTRODUCER SET (K132713) | Navilyst Medical, Inc. | 2013-09-27 |
| VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING (K131860) | Us Vascular, LLC | 2013-09-27 |
| MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING (K132030) | Medtronic, Inc. | 2013-09-27 |
| LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST (K131618) | Terumo Cardiovascular Systems Corporation | 2013-09-27 |
| VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM (K132659) | Volcano Corporation | 2013-09-27 |
| TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR (K132696) | GE Healthcare Finland Oy | 2013-09-27 |
| PHILIPS DXL 12/16-LEAD ECG ALGORITHM (K132068) | Philips Medical Systems | 2013-09-26 |
| COSEAL (K131411) | Jilin Coronado Medical , Ltd. | 2013-09-26 |
| PRECISION ONE LIFECARE; DETECTO; DETECTO (K130952) | Precision One Lifecare, Ltd. | 2013-09-26 |
| CG+ ARROW JACC POWERED BY ARROW VPS STYLET (K132133) | Arrow International (Subsidiary of Teleflex Inc.) | 2013-09-26 |
| PRIMI SUPPORT CATHETER (K132701) | Thermopeutix, Inc. | 2013-09-26 |
| NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER (K132777) | Ev3, Inc. | 2013-09-26 |
| WINGMAN EXTENDABLE TIP SUPPORT CATHETER (K132420) | Reflow Medical | 2013-09-19 |
| TRANSTEK GLASS BODY FAT ANALYZER (K131394) | Guangdong Transtek Medical Electronics Co., Ltd. | 2013-09-18 |
| ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM (K130232) | Jinxinbao Electronic Co.,Ltd | 2013-09-17 |
| ANSWATCH WRIST MONITOR MODEL TS-0411 (K123130) | Taiwan Scientific Corporation | 2013-09-17 |
| HEARTSPAN STEERABLE INTRODUCER KIT (K132164) | Merit Medical Systems, Inc. | 2013-09-17 |
| HEART SYNC (K131494) | Heart Sync, Inc. | 2013-09-16 |