| KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER (K111745) | Card Guard Scientific Survival , Ltd. | 2011-08-01 |
| PRIMEWIRE PRESTIGE PLUS (K111395) | Volcano Corporation | 2011-08-01 |
| BENELLI ACCESS DEVICE (K111334) | Vascular Solutions, Inc. | 2011-08-01 |
| GLIDECROSS SUPPORT CATHETER (K111556) | Terumo Medical Corp. | 2011-07-29 |
| OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME (K111884) | LeMaitre Vascular, Inc. | 2011-07-29 |
| M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS (K110723) | Masimo Corporation | 2011-07-28 |
| AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF (K111972) | Medtronic, Inc. | 2011-07-27 |
| AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER, (K110156) | Contec Medical System Co., Ltd. | 2011-07-27 |
| PATCH, PLEDGET AND INTRACARDIAC (K111187) | Cormatrix Cardiovascular, Inc. | 2011-07-26 |
| DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM (K111388) | Cardiovascular Systems, Inc. | 2011-07-26 |
| DIXTAL DZ-4100 SERIES PULSE OXIMETER (K103285) | Dixtal Medical, Inc. | 2011-07-25 |
| CXI TRIFORCE (K111263) | Cook Incorporated | 2011-07-25 |
| CARDIAC TRIGGER MONITOR (K110987) | Ivy Biomedical Systems, Inc. | 2011-07-22 |
| EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE (K111750) | Angioslide, Ltd. | 2011-07-21 |
| PATIENT MONITOR (K110922) | Edan Instruments, Inc. | 2011-07-20 |
| MEDLINE VESSEL CANNULA (K111147) | Medline Industries, Inc. | 2011-07-19 |
| NEURON MAX SYSTEM (K111380) | Penumbra, Inc. | 2011-07-19 |
| BODY ANALYSIS SCALE, MODEL BG 17 (K110928) | Shenzhen Healthcare Electronic Technology Co., Ltd. | 2011-07-15 |
| PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA (K103685) | Beijing Rongrui-Century Scie. & Tech. Co., Ltd. | 2011-07-15 |
| ACG-8511 PORTABLE ECG MONITOR (K110328) | Andon Health Co, Ltd. | 2011-07-15 |
| THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER (K111417) | Access Scientific, Inc. | 2011-07-15 |
| FALCON (K111416) | Viasonix , Ltd. | 2011-07-15 |
| PERCUPRO MESSENGER BALLOON CATHETER (K094048) | Cardiosolutions, Inc. | 2011-07-14 |
| ECG PEN (K103077) | Meridian Dynamics Biomedical, Inc. | 2011-07-13 |
| MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR (K111652) | Microlife Intellectual Property GmbH | 2011-07-13 |
| VACCESS PTA DILATATION CATHETER (K111850) | C.R. Bard, Inc. | 2011-07-13 |
| ENDOLOGIX AFX INTRODUCER SYSTEM (K111747) | Endologix, Inc. | 2011-07-12 |
| HERO (K111601) | Medical Predictive Science Corp. | 2011-07-08 |
| FORA P30 PLUS MULTI-MODE BLOOD PRESSURE MONITORING SYSTEM (K110044) | Foracare, Inc. | 2011-07-07 |
| MODIFIED CONCENTRIC MICROCATHETER (K111619) | Concentric Medical, Inc. | 2011-07-06 |
| WIRELESS MONITORING SYSTEM (K110809) | Carefusion 303, Inc. | 2011-07-05 |
| ASCOM MOBILE MONITORING GATEWAY (MMG) (K111215) | Ascom (Sweden) AB | 2011-07-05 |
| MERIT MARQUIS FLOW SWITCH (K110643) | Merit Medical Systems, Inc. | 2011-07-01 |
| ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK (K102648) | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2011-07-01 |
| FATHOM (TM) 14 STEERABLE GUIDEWIRE (K111498) | Boston Scientific Corp | 2011-06-30 |
| FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX (K111485) | Boston Scientific Corporation | 2011-06-30 |
| SIROCCO THERMAL REGULATING SYSTEM (K102856) | Galmaz Biotech S.L. | 2011-06-30 |
| MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003 (K111488) | Bridgepoint Medical | 2011-06-30 |
| VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY (K111180) | Vasomedical, Inc. | 2011-06-28 |
| PATIENT MONITOR (K101692) | Contec Medical System Co., Ltd. | 2011-06-28 |
| AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE (K111658) | Medtronic, Inc. | 2011-06-28 |
| CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING (K103520) | Edwards Lifesciences, LLC | 2011-06-24 |
| VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY (K111096) | Vasomedical, Inc. | 2011-06-24 |
| SUREFIRE INFUSION CATHETER SYSTEM (K110459) | Surefire Medical, Inc. | 2011-06-24 |
| SENSI (K110704) | Diacoustic Medical Devices (Pty) , Ltd. | 2011-06-24 |
| AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE (K111657) | Medtronic, Inc. | 2011-06-23 |
| THE PICC WAND (R) PEELABLE SAFETY INTRODUCER (K111138) | Access Scientific, Inc. | 2011-06-22 |
| CENTRIMAG DRAINAGE CANNULA KIT (K110983) | Levitronix, LLC | 2011-06-20 |
| CENTRIMAG RETURN CANNULA KIT (K110980) | Levitronix, LLC | 2011-06-20 |
| EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC (K103783) | Fiab Spa | 2011-06-16 |
| AZUR DETACHABLE 35 PLATINUM COIL SYSTEM (K111307) | MicroVention, Inc. | 2011-06-15 |
| VISENSIA, VISENSIA WITH ALERT (K110953) | Obs Medical | 2011-06-15 |
| SPACELABS PATHFINDER SL HOLTER ANALYZER (K110001) | Spacelabs Healthcare, Ltd. | 2011-06-14 |
| EV1000 CLINICAL PLATFORM (K110597) | Edwards Lifesciences | 2011-06-14 |
| MAX PULSE SYSTEM (K110374) | Medicore Co., Ltd. | 2011-06-13 |
| AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR (K102507) | Tz Medical, Inc. | 2011-06-13 |
| ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS (K103584) | Shenzhen Envisen Industry Co. Limited | 2011-06-10 |
| EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER (K110133) | Creganna-Tactx Medical | 2011-06-10 |
| ENGAGE/ENGAGE TR INTRODUCERS (K111092) | St Jude Medical | 2011-06-09 |
| POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS (K102496) | Cardiac Science Corporation | 2011-06-09 |
| PACEART OPTIMA SYSTEM SOFTWARE (K110693) | Medtronic, Inc. | 2011-06-08 |
| ERKA. PERFECT-ANEROID (K103637) | Erka Kallmeyer Medizintechnik GmbH | 2011-06-08 |
| MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST RE (K111007) | Midwest Reprocessing Center, LLC | 2011-06-08 |
| BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR (K110645) | Sonosite,Inc. | 2011-06-03 |
| CARDIO XP (K102767) | Bionet Co., Ltd. | 2011-06-03 |
| ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F (K111252) | Boston Scientific Corp | 2011-06-02 |
| OMNI II PATIENT MONITOR (K103737) | Infinium Medical | 2011-06-02 |
| MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER (K110617) | Abbott Vascular | 2011-06-02 |
| JETSTREAM G3 (R) SF 1.6 SYSTEM (K111229) | Pathway Medical Technologies, Inc. | 2011-06-01 |
| CONNEX VITAL SIGNS MONITOR 6000 SERIES (K110516) | Welch Allyn, Inc. | 2011-06-01 |
| M4 MONITOR (K110957) | Spectrum Medical, Llp | 2011-05-31 |
| .014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS (K111295) | Boston Scientific Corporation | 2011-05-31 |
| TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995 (K101681) | Zhongshan Transtek Electronics Co., Ltd. | 2011-05-27 |
| AFX INTRODUCER SYSTEM (K110090) | Endologix, Inc. | 2011-05-26 |
| MUSE CARDIOLOGY INFORMATION SYSTEM (K110132) | Ge Medical Systems Information Technologies, Inc. | 2011-05-25 |
| ARSTASIS DILATOR ADAPTER (K103421) | Arstasis, Inc. | 2011-05-24 |
| LIFEBRIDGE (K111384) | Lifebridge Medizintechnik AG | 2011-05-24 |
| 4D LV-ANALYSIS 3.0 (K110746) | Tomtec Imaging Systems GmbH | 2011-05-24 |
| ANGIOJET SOLENT OMNI THROMBECTOMY SET (K111182) | Medrad, Inc. | 2011-05-24 |
| GORE EMBOLIC FILTER (K103500) | W. L. Gore & Associates, Inc. | 2011-05-23 |
| SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75 (K111154) | Biotronik, Inc. | 2011-05-23 |
| HYDROFIX VASO SHIELD (K111137) | Mimedx Group, Inc. | 2011-05-20 |
| VITALSENS, AINGEAL, V-POD (K110015) | Intelesens Limited | 2011-05-20 |
| SURESIGNS VS2 VITAL SIGNS MONITOR (K111114) | Philips Medical Systems | 2011-05-20 |
| WITHINGS BLOOD PRESSURE MONITOR (K110872) | Withings | 2011-05-20 |
| SURESIGNS VSI VITAL SIGNS MONITOR (K110803) | Philips Medical Systems | 2011-05-20 |
| MITRA-LIFT (K103812) | Sciencity Co., Ltd. | 2011-05-18 |
| CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283 (K103377) | Brivant, Ltd. | 2011-05-18 |
| VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR (K103094) | Edwards Lifesciences, LLC | 2011-05-17 |
| MAC 600 RESTING ECG ANALYSIS SYSTEM (K103765) | Ge Medical Systems Information Technologies, Inc. | 2011-05-17 |
| TERUMO SUPPORT CATHETER (K110540) | Terumo Medical Corp. | 2011-05-13 |
| ELECTRONIC SPHYGMOMANOMETER (K110774) | Contec Medical System Co., Ltd. | 2011-05-13 |
| ZOLL RESCUENET EPCR MODEL RESCUENET EPCR (K103473) | ZOLL Medical Corporation | 2011-05-13 |
| ELECTRONIC SPHYGMOMANOMETER (K110775) | Contec Medical Systems Co.,Ltd | 2011-05-13 |
| ONESTEP PEDIATRIC MFE'S (K110978) | ZOLL Medical Corporation | 2011-05-13 |
| ACTIVECARE SFT (K110159) | Medical Compression Systems (Dbn) , Ltd. | 2011-05-12 |
| ASPIRA PLEURAL DRAINAGE SYSTEM (K110409) | C.R. Bard, Inc. | 2011-05-11 |
| AGILIS NXT STEERABLE INTRODUCER (K110450) | St Jude Medical | 2011-05-10 |
| CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND M (K102725) | Bridge Medical, Inc. | 2011-05-10 |
| VENODYNE V810 (K110358) | Microtek Medical, Inc. | 2011-05-05 |