| EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER (K132175) | Edwards Lifesciences, LLC | 2013-09-13 |
| INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM (K132578) | Boston Scientific Corp | 2013-09-13 |
| CEROX (K131854) | Or-Nim Medical , Ltd. | 2013-09-13 |
| AUTOMATIC BLOOD PRESSURE MONITOR (K130925) | Honsun (Nantong) Co., Ltd. | 2013-09-12 |
| PULSE OXIMETER (K131021) | Nonin Medical, Inc. | 2013-09-11 |
| IHEALTH FINGERTIP PULSE OXIMETER (K131111) | Andon Health Co, Ltd. | 2013-09-11 |
| EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE (K132073) | St Jude Medical | 2013-09-09 |
| ALIVECOR HEART MONITOR (K130409) | AliveCor, Inc. | 2013-09-06 |
| PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300 (K131452) | St. Jude Medical Systems AB | 2013-09-05 |
| THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH (K131148) | Access Scientific, LLC | 2013-09-04 |
| BIOSPACE (K131064) | Biospace Corporation Limited | 2013-09-04 |
| SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION (K131044) | Diacoustic Medical Devices (Pty) , Ltd. | 2013-09-04 |
| VITAL SIGNS MONITOR (K131818) | Edan Instruments, Inc. | 2013-08-30 |
| ReVive PV (Peripheral Vasculature) Thrombectomy Device (K132281) | Codman & Shurtleff, Inc. | 2013-08-30 |
| MRI PATIENT MONITORING SYSTEM (K132359) | Invivo Corporation | 2013-08-30 |
| HORIZON XVU (FFR) (K123792) | Mennen Medical , Ltd. | 2013-08-30 |
| PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6 (K131558) | Shenzhen Pango Electronic Co., Ltd. | 2013-08-30 |
| ENSITE VELOCITY SYSTEM (K130727) | St Jude Medical | 2013-08-29 |
| CONCIERGE GUIDING CATHETER (K132409) | Merit Medical Systems, Inc. | 2013-08-29 |
| COLIGN (K131124) | Jilin Coronado Medical , Ltd. | 2013-08-28 |
| LIDCO CNAP MODULE (K131048) | Lidco, Ltd. | 2013-08-28 |
| CARESCAPE MONITOR B850 (K131414) | GE Healthcare Finland Oy | 2013-08-28 |
| CARESCAPE MONITOR B650 (K131223) | GE Healthcare Finland Oy | 2013-08-28 |
| NT1D VITAL SIGNS MONITOR (K123797) | New Tech, Inc. | 2013-08-27 |
| KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER (K132360) | Covidien | 2013-08-27 |
| SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL (K131978) | Biotronik, Inc. | 2013-08-23 |
| PRE-FORMED GUIDEWIRES (K130798) | Lake Region Medical, Inc. | 2013-08-23 |
| CARDIODAY (K130516) | Getemed Medizin- Und Informationstechnik AG | 2013-08-23 |
| PROGIGY SUPPORT CATHETER (K130714) | Radius Medical, LLC | 2013-08-22 |
| CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000 (K131085) | Mespere Lifesciences, Inc. | 2013-08-22 |
| LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR (K130454) | Physio-Control, Inc. | 2013-08-21 |
| AXERA 2 ACCESS SYSTEM (K132263) | Arstasis, Inc. | 2013-08-19 |
| INTELLIVUE PATIENT MONITOR (K131829) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2013-08-16 |
| INTERMITTENT PNEUMATIC COMPRESSION DEVICE (K123830) | Dalian Labtek Science & Development Co., Ltd. | 2013-08-16 |
| AMECO SHEATH INTRODUCER (K131144) | Ameco Medical Industries | 2013-08-15 |
| CONTRAST CONSERVATION SYSTEM (K131478) | Osprey Medical, Inc. | 2013-08-15 |
| AMPLATZER TORQ VUE LP DELIVERY SYSTEM (K131063) | St Jude Medical | 2013-08-15 |
| 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER (K130687) | Medical Components, Inc. | 2013-08-15 |
| AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR (K123882) | Ageless Health Industrial | 2013-08-14 |
| LASSO NAV DUO LOOP CATHETER (K130602) | Biosense Webster, Inc. | 2013-08-14 |
| HOPER PTCA BALLOON CATHETER (K123473) | Lepu Medical Technology (Beijing) Co., Ltd. | 2013-08-13 |
| PHILIPS SURESIGNS CENTRAL (K131032) | Philips Medical Systems | 2013-08-12 |
| CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER (K132197) | Pendracare International, B.V. | 2013-08-12 |
| INTEL-GE CARE INNOVATIONS CONNECT RCM (K130821) | Intel-Ge Care Innovations, LLC | 2013-08-09 |
| PTS-X SIZING BALLOON CATHETER (K131869) | NuMED, Inc. | 2013-08-08 |
| FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0 (K131450) | Ostial Corporation | 2013-08-06 |
| EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME (K132190) | LeMaitre Vascular, Inc. | 2013-08-05 |
| SIDEKICK AND USHER SUPPORT CATHETERS (K131493) | C.R. Bard, Inc. | 2013-08-02 |
| CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC (K131079) | Creganna Medical Devices | 2013-08-01 |
| CARDIO VISION MICS AORTIC CLAMPS (K123571) | Cardiomedical GmbH | 2013-08-01 |
| VERIZON WIRELESS REMOTE HEALTH MANAGEMENT SYSTEM (K122458) | Cello Partnership D/B/A Verizon Wireless | 2013-07-30 |
| MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM (K124000) | Medapps Inc., Dba Alere Connect | 2013-07-30 |
| 6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP (K132008) | Medtronic, Inc. | 2013-07-30 |
| WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET (K131361) | Covidien | 2013-07-29 |
| PTFE SUPER SHEATH INTRODUCER (K130855) | Martech Medical Products | 2013-07-29 |
| ANGIOJET ULTRA POWER PULSE KIT (K130381) | Medrad, Inc. | 2013-07-29 |
| MERIT HYDROPHILIC GUIDE WIRE (K131710) | Merit Medical Systems, Inc. | 2013-07-29 |
| SEER 1000 (K130785) | Getemed Medizin- Und Informationstechnik AG | 2013-07-26 |
| VDRIVE W/V-SONO (K122659) | Stereotaxis, Inc. | 2013-07-26 |
| SENSIS, SENSIS LITE (K131812) | Siemens Medi Cal Solutions, Inc. | 2013-07-25 |
| BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE (K131964) | Medtronic, Inc. | 2013-07-24 |
| EDWARDS EMBOL-X INTRODUCER SHEATH (K123714) | Edwards Lifesciences, LLC | 2013-07-24 |
| SAM JUNCTIONAL TOURNIQUET (K131561) | Sam Medical Products | 2013-07-24 |
| HEM-6131 (K131742) | Omron Healthcare, Inc. | 2013-07-24 |
| SPACELABS HEALTHCARE CARDIOEXPRESS (K130207) | Spacelabs Healthcare, Ltd. | 2013-07-23 |
| SORIN CONNECT DATA MANAGEMENT SYSTEM (K131816) | Sorin Group Deutschland GmbH | 2013-07-23 |
| NIGHTINGALE MONITORING SYSTEM (K130740) | Zoe Medical, Inc. | 2013-07-23 |
| MICRO AMBULATORY ECG RECORDER (K131572) | Dimetek Digital Medical Technologies, Ltd. | 2013-07-22 |
| IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE (K131306) | Bio Compression Systems, Inc. | 2013-07-22 |
| RHYTHMIA MAPPING SYSTEM (K130750) | Rhythmia Medical, Inc. | 2013-07-22 |
| IHEALTH CLOUD (K131203) | Andon Health Co, Ltd. | 2013-07-19 |
| CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER (K131332) | Cardiosolutions, Inc. | 2013-07-19 |
| MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER (K130079) | Reflectance Medical, Inc. | 2013-07-19 |
| CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR (K131179) | Thoratec Corp | 2013-07-18 |
| BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM (K131327) | Bio Compression Systems, Inc. | 2013-07-18 |
| VASCULAIRE COMPRESSION SYSTEM, VASCULAIRE SLEEVE (FOOT & CALF), VASCULAIRE SLEEVE (CALF) (K131046) | Venous Health Systems, Inc. | 2013-07-18 |
| ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE (K130766) | Cook, Inc. | 2013-07-17 |
| EXPORT ADVANCE ASPIRATION CATHETER (K130536) | Medtronic, Inc. | 2013-07-16 |
| TRUSCOPE SERIES PATIENT MONITOR (K131763) | Guangdong Biolight Meditech Co., Ltd. | 2013-07-15 |
| CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION (K130360) | Constant Care, LLC | 2013-07-15 |
| EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL (K131382) | Invivo Corporation | 2013-07-15 |
| HEARTSINE SAMARITAN PAD 350P (K123881) | Heartsine Technologies, Inc. | 2013-07-11 |
| CLINICAL ALERT NOTIFICATION (K130339) | Extension , Inc. | 2013-07-11 |
| DLP CORONARY OSTIAL PERFUSION CANNULAE (K131269) | Medtronic, Inc. | 2013-07-10 |
| EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT (K130391) | Boston Scientific Corp | 2013-07-10 |
| AMBIO REMOTE HEALTH MONITORING SYSTEM (K130676) | Arrayent Health, LLC D/B/A Ambio Health | 2013-07-08 |
| WRIST AUTOMATIC BLOOD PRESSURE MONITOR (K131463) | Honsun (Nantong) Co., Ltd. | 2013-07-08 |
| ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING (K131666) | Maquet Cardiopulmonary, AG | 2013-07-05 |
| CP150 ELECTROCARDIOGRAPH (K131573) | Welch Allyn, Inc. | 2013-07-03 |
| AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER (K131786) | Airstrip Technologies, LP | 2013-07-03 |
| IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS (K123074) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2013-07-03 |
| REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM (K123803) | Reverse Medical Corporation | 2013-07-02 |
| VIDA PTV DILATATON CATHETER (K131002) | C.R. Bard, Inc. | 2013-07-02 |
| CIRONA DVT FOOT GARMENT (K131743) | Devon Medical, Inc. | 2013-07-01 |
| HEATER-COOLER UNIT HCU 40 (K130300) | Maquet Cardiopulmonary, AG | 2013-07-01 |
| CODA BALLOON CATHETER (K122917) | Cook, Inc. | 2013-06-28 |
| ZOE FLUID STATUS MONITOR (K131509) | Noninvasive Medical Technologies, Inc. | 2013-06-28 |
| MONITOR B40 (K130584) | Ge Medical Systems China Co., Ltd. | 2013-06-26 |
| EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI) (K121628) | Epi Mobile Health Solutions (S) Pte, Ltd. | 2013-06-25 |
| PRIMI AND SECONDI SUPPORT CATHETERS (K130850) | Thermopeutix, Inc. | 2013-06-25 |