| DEVON ACCUBP CUFF (K090664) | Devon Medical, Inc. | 2009-03-23 |
| SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS (K090483) | Philips Medical Systems | 2009-03-20 |
| FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS .035 PTA CATHETER (K090509) | Abbott Vascular-Vascular Solutions | 2009-03-20 |
| DIAMONDBACK 360 DBX (K090521) | Cardiovascular Systems, Inc. | 2009-03-20 |
| BODYMETRIX BX2000 (K082147) | Intelametrix, Inc. | 2009-03-20 |
| FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M (K083697) | Fukuda Denshi USA, Inc. | 2009-03-19 |
| FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030) (K083892) | Cas Medical Systems, Inc. | 2009-03-19 |
| AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER (K083919) | Invatec Innovative Technologies, S.R.L. | 2009-03-13 |
| HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM (K090610) | Hospira, Inc. | 2009-03-13 |
| LIFEPAK 15 MONITOR/DEFIBRILLATOR (K082937) | Physio-Control, Inc. | 2009-03-11 |
| JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE) (K090325) | Pathway Medical Technologies, Inc. | 2009-03-11 |
| HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05 (K083738) | Abbott Vascular | 2009-03-11 |
| PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 (K083677) | Commwell , Ltd. | 2009-03-10 |
| ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING (K081081) | Zoll Medical Corporation, World Wide Headquarters | 2009-03-09 |
| N-600X WITH SPD, OXIMAX N-600X (K083325) | Covidien | 2009-03-09 |
| SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM (K082528) | Noble Anesthesia-Air, Inc. | 2009-03-06 |
| QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100 (K083079) | Quanta Computer, Inc. | 2009-03-05 |
| M-50 SERIES SPO2 SENSOR (K082487) | Beijing Choice Electronic Technololgy Co., Ltd. | 2009-03-04 |
| MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE (K090274) | Micrus Endovascular Corporation | 2009-03-03 |
| REEKROSS FAMILY OR OTW PTA CATHETERS (K083596) | ClearStream Technologies , Ltd. | 2009-03-02 |
| SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598 (K083395) | Andon Health Co, Ltd. | 2009-02-27 |
| CONCERTO DETACHABLE COIL SYSTEM (K090046) | Micro Therapeutics, Inc. | 2009-02-27 |
| PROTRON TECHNOLOGIES, LLC STETHOTRON (K082771) | Protron Technologies, LLC | 2009-02-27 |
| ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC (K083683) | Genesee Biomedical, Inc. | 2009-02-25 |
| INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5 (K082583) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009-02-25 |
| TAD AND TAD II TAPERED GUIDE WIRES (K083732) | Abbott Vascular | 2009-02-25 |
| .035 LOC GUIDE WIRE EXTENSION (K083713) | Abbott Vascular | 2009-02-23 |
| E.S TECK ( ELECTRO SENSOR TECK) (K083229) | Ld Technology, LLC | 2009-02-23 |
| STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012 (K083727) | Bridgepoint Medical | 2009-02-20 |
| MAC 800 RESTING ECG ANALYSIS SYSTEM (K090212) | Ge Medical Syst. Information Technologies | 2009-02-19 |
| ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM (K090276) | Siemens Medical Solutions USA, Inc. | 2009-02-19 |
| CARDITTE MICROTEL (K082124) | Et Medical Devices Spa | 2009-02-19 |
| QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000 (K082117) | Maquet Cardiopulmonary, AG | 2009-02-18 |
| ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS (K083735) | Medtechs, LLC | 2009-02-18 |
| MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59 (K083855) | Acumen Medical, Inc. | 2009-02-17 |
| MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE (K083639) | Ge Medical Systems Information Technologies | 2009-02-17 |
| CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE (K082930) | Cardiva Medical, Inc. | 2009-02-13 |
| CARDIAC TRIGGER, MODEL: CTM300 (K083854) | Ivy Biomedical Systems, Inc. | 2009-02-13 |
| TERUMO ROCSAFE HYBRID PERFUSION SYSTEM (K082321) | Terumo Cardiovascular Systems Corp. | 2009-02-13 |
| ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33 (K083309) | Zargis Medical Corp. | 2009-02-13 |
| MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113 (K090085) | Concentric Medical, Inc. | 2009-02-12 |
| SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT (K083828) | Transoma | 2009-02-11 |
| VASCUTEK CANNULA GRAFT, MODEL CGS2008S (K081560) | Vascutek, Ltd. | 2009-02-10 |
| HI-TORQUE VERSACORE GUIDE WIRE (K083706) | Abbott Vascular | 2009-02-06 |
| CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX (K082268) | Oridion Capnography, Inc. | 2009-02-06 |
| MEDTRONIC ANGIOGRAPHIC GUIDE WIRES (K082873) | Medtronic Vascular | 2009-02-06 |
| RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) (K090040) | Terumo Medical Corp. | 2009-02-06 |
| BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES (K080987) | Bridgepoint Medical | 2009-02-06 |
| 6F TAIGA GUIDING CATHETER (K083422) | Medtronic Vascular | 2009-02-06 |
| RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO (K081927) | Renu Medical, Inc. | 2009-02-06 |
| GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING (K082082) | Gish Biomedical, Inc. | 2009-02-04 |
| GORE FLOW REVERSAL SYSTEM (K083300) | W. L. Gore & Associates, Inc. | 2009-02-04 |
| MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE (K083523) | Merit Medical Systems, Inc. | 2009-02-04 |
| GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING (K081947) | Gish Biomedical, Inc. | 2009-02-04 |
| CROSSOVER (K083269) | Thomas Medical Products, Inc. | 2009-02-03 |
| BLAZER DX-20 DIAGNOSTIC CATHETER (K081576) | Boston Scientific Corp | 2009-02-03 |
| ASAHI CORSAIR MICROCATHETER (K083127) | Asahi Intecc Co., Ltd. | 2009-02-03 |
| AVIVO MOBILE PATIENT MANAGEMENT SYSTEM (K083287) | Corventis, Inc. | 2009-02-03 |
| BLOOD PRESSURE MONITOR, ZSBP-003/004/005/006/007/008 AND ZSBP-102/103/104/105/106/107 (K090027) | Zen Strong Medical Technology Co., Ltd. | 2009-02-02 |
| WILDCAT 7F GUIDEWIRE SUPPORT CATHETER (K083313) | Avinger, Inc. | 2009-02-02 |
| VISION HOLLOW FIBER OXYGENATOR WITH HA COATING (K080708) | Gish Biomedical, Inc. | 2009-02-02 |
| ASAHI SUOH PTCA GUIDE WIRE (K083904) | Asahi Intecc Co., Ltd. | 2009-01-29 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7941 (K083319) | Andon Health Co, Ltd. | 2009-01-29 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5904 (K083318) | Andon Health Co, Ltd. | 2009-01-29 |
| FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5961 (K083246) | Andon Health Co, Ltd. | 2009-01-29 |
| FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5902 (K083317) | Andon Health Co, Ltd. | 2009-01-29 |
| FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7906 (K083247) | Andon Health Co, Ltd. | 2009-01-29 |
| FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7902 (K083248) | Andon Health Co, Ltd. | 2009-01-29 |
| I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016 (K073593) | Deltex Medical Limited | 2009-01-29 |
| GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951 (K081846) | Vascular Solutions, Inc. | 2009-01-28 |
| LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM (K081878) | LeMaitre Vascular, Inc. | 2009-01-27 |
| GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING (K081838) | Gish Biomedical, Inc. | 2009-01-26 |
| JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300 (K083489) | Pathway Medical Technologies, Inc. | 2009-01-23 |
| ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR (K083835) | St Jude Medical | 2009-01-23 |
| CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200 (K083470) | Edwards Lifesciences, LLC | 2009-01-23 |
| GISH TUBING AND CONNECTORS WITH HA COATING (K081881) | Gish Biomedical, Inc. | 2009-01-23 |
| SYRINGE WITH HANDI-FIL (K082212) | Mallinckrodt Inc., Liebel-Flarsheim Business | 2009-01-22 |
| PM-1000F+PATIENT MONITOR (K082887) | Advanced Instrumentations, Inc. | 2009-01-16 |
| PAM 3000 (K082626) | Wireless 2000 RF & Uwb Technologies , Ltd. | 2009-01-16 |
| BIOLAND BLOOD PRESSURE MONITOR (K083681) | Bioland Technology, Ltd. | 2009-01-16 |
| HEALTH MANAGER, VERSION 1.1 (K081499) | Biocomfort Diagnostics GmbH & Co. KG | 2009-01-16 |
| FORA TELEHEALTH SYSTEM (K083046) | Taidoc Technology Corporation | 2009-01-16 |
| INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, AND MP90 (K083517) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009-01-16 |
| LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES (K090004) | Levitronix, LLC | 2009-01-15 |
| GISH ARTERIAL FILTER WITH HA COATING (K081054) | Gish Biomedical, Inc. | 2009-01-15 |
| MINNIE SUPPORT CATHETER (K082337) | Vascular Solutions, Inc. | 2009-01-15 |
| MIROXI (K081033) | Mir Medical Intl. Research Srl | 2009-01-15 |
| JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE) (K083837) | Pathway Medical Technologies, Inc. | 2009-01-13 |
| OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120 (K083814) | Cordis Corp., A Johnson & Johnson Co. | 2009-01-13 |
| ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 (K082746) | Insightra Medical, Inc. | 2009-01-12 |
| MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC (K082905) | Medrad, Inc. | 2009-01-12 |
| VITAL SIGNS MONITOR, MODEL: MD500B (K082787) | Beijing Choice Electronic Technololgy Co., Ltd. | 2009-01-12 |
| ASAHI GUIDE WIRE EXTENSION, MODEL AG149000 (K083145) | Asahi Intecc Co., Ltd. | 2009-01-12 |
| CONFIDANT, MODEL 2.6 (K083331) | Confidant, Inc. | 2009-01-09 |
| G1B PULSE OXIMETER (K082789) | General Meditech, Inc. | 2009-01-07 |
| REFLEXION HD HIGH-DENSITY MAPPING CATHETER (K080179) | St Jude Medical | 2009-01-07 |
| CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE (K081924) | Calhealth, Inc. | 2009-01-07 |
| VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02 (K081258) | Biosense Webster, Inc. | 2009-01-06 |
| MERIT MICROCATHETER (K082613) | Merit Medical Systems, Inc. | 2008-12-30 |
| VICOR PD2I ANALYZER, VERSION 2.1 (K082709) | Vicor Technologies, Inc. | 2008-12-29 |