| ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION (K093501) | Spacelabs Medical, Inc. | 2009-11-24 |
| NBP CUFF (K092999) | Draeger Medical AG & Co. KG | 2009-11-24 |
| MICRUS MICROCATHETER, MODEL COURIER 270 (K092702) | Micrus Endovascular Corporation | 2009-11-20 |
| SKYLINE 55, MODEL VER 1 (K092153) | Larsen & Toubro Limited | 2009-11-20 |
| SCOUTPRO 7F LONG CATHETERS (K093303) | Biotronik, Inc. | 2009-11-20 |
| RADAR VASCULAR COMPRESSION DEVICES (K092503) | Advanced Vascular Dynamics | 2009-11-19 |
| CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK (K093389) | Computerized Screening, Inc. | 2009-11-17 |
| FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KB (K092163) | Health & Life Co., Ltd. | 2009-11-16 |
| OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P (K092549) | Bio Medical Technologies Co., Ltd. | 2009-11-16 |
| PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441 (K091176) | Philips Medical Systems | 2009-11-13 |
| POWERCROSS .018 OTW PTA DILATION CATHETER (K093286) | Ev3, Inc. | 2009-11-13 |
| TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM (K093301) | Ev3, Inc. | 2009-11-06 |
| MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER; RAD 87 PULSE CO-OXIMETER (K091241) | Masimo Corporation | 2009-11-06 |
| ENVOY GUIDING CATHETERS (K093184) | Codman & Shurtleff, Inc. | 2009-11-06 |
| ASEPT PLEURAL DRAINAGE SYSTEM (K093307) | Pfm Medical, Inc. | 2009-11-06 |
| SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM (K092463) | Sorin Group Deutschland GmbH | 2009-11-05 |
| MODIFICATION TO MODIFIED HD GUIDE CATHETER (K092298) | Concentric Medical, Inc. | 2009-11-05 |
| HEADWAY 21 MICROCATHETER, MODEL: MC212150S (K093160) | MicroVention, Inc. | 2009-11-05 |
| GDS-DCS (K091367) | Guided Delivery Systems | 2009-11-05 |
| ENGAGE TR INTRODUCER (K093130) | St Jude Medical | 2009-11-04 |
| GATOR CLIPSEAL PLUG (K092563) | Vascular Solutions, Inc. | 2009-11-04 |
| GUIDELINER CATHETER, MODELS 5571, 5572, 5573 (K091750) | Vascular Solutions, Inc. | 2009-11-04 |
| INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90 (K091927) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009-11-03 |
| MODEL 220 PATIENT MAGNET (K092364) | Cyberonics, Inc. | 2009-11-03 |
| REPROCESSED PULSE OXIMETER SENSORS (K092368) | Sterilmed, Inc. | 2009-11-03 |
| SPECTRANETICS VISISHEATH DILATOR SHEATH (K092378) | Spectranetics Corp. | 2009-11-02 |
| F.A.S.T. SYSTEM SED AND CXD (K092623) | Genesis Medical Interventional, Inc. | 2009-10-30 |
| QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000 (K090689) | Maquet Cardiopulmonary, AG | 2009-10-29 |
| PTFE PEELABLE INTRODUCER (K093023) | Great Batch Medical | 2009-10-29 |
| REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER (K092361) | Invatec S.P.A. | 2009-10-29 |
| AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610 (K093002) | MicroVention, Inc. | 2009-10-28 |
| ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100 (K092245) | Honsun (Nantong) Co., Ltd. | 2009-10-28 |
| MERIT LAUREATE HYDROPHILIC GUIDE WIRE (K092303) | Merit Medical Systems, Inc. | 2009-10-27 |
| SAVI WIRELESS, MODEL PM500 (K091696) | Medicomp, Inc. | 2009-10-26 |
| INSTRUMED VASCULAR CLAMPS (K092544) | Instrumed International, Inc. | 2009-10-26 |
| MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BS1-3C (K092456) | Microlife Intellectual Property GmbH | 2009-10-23 |
| PC ECG, MODEL SE-1010 (K092010) | Edan Instruments, Inc. | 2009-10-22 |
| LARGE FACE ANEROID SPHYGMOMANOMETER, WALL MODEL, DESK MODEL, MOBILE STAND MODEL, MODEL 41XX, 42XX, 43XX (K092604) | Trimline Medical Products Corp. | 2009-10-21 |
| REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10 (K092425) | Ascent Healthcare Solutions | 2009-10-21 |
| VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH (K091414) | Biocare Corp. | 2009-10-21 |
| REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES (K092101) | Nonin Medical, Inc. | 2009-10-21 |
| ESTECH EASYFLOW CANNULA WITH GUIDEWIRE (K091542) | Endoscopic Technologies, Inc. D/B/A Estech | 2009-10-20 |
| DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150 (K090487) | Coeur, Inc. | 2009-10-19 |
| APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR (K092895) | Sorin Group Italia S.R.L. | 2009-10-19 |
| GUIDED MEASUREMENT CATHETER (GMC) (K091780) | Mediguide, Ltd. | 2009-10-16 |
| SJM ATTUNE ANNULOPLASTY RING (K092876) | St Jude Medical | 2009-10-16 |
| EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 (K092913) | Ep Medsystems | 2009-10-16 |
| GUIDED MEDICAL POSITIONING SYSTEM (GMPS) (K091781) | Mediguide, Ltd. | 2009-10-16 |
| HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104 (K091458) | Ev3 Neurovascular | 2009-10-15 |
| MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6 (K092177) | Invatec S.P.A. | 2009-10-15 |
| MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8 (K092838) | Masimo Corporation | 2009-10-15 |
| LIFEBRIDGE B2T, MODEL 7001 (K090006) | Lifebridge Medizintechnik AG | 2009-10-15 |
| STENT GRAFT BALLOON CATHETER (K091624) | Via Biomedical, Inc. | 2009-10-15 |
| RHYTHM OF LIFE, MODEL R0901-05 (K092408) | Rapid Response Solutions, LLC | 2009-10-14 |
| HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131 (K091703) | Concentric Medical, Inc. | 2009-10-14 |
| ELECTROFLUIDGRAPH (K091369) | Akern USA, LLC | 2009-10-14 |
| DISPOSAL ECG ELECTRODES, MODEL EASYRODE (K092389) | Suzuken Co., Ltd. | 2009-10-13 |
| CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES (K090017) | Biosense Webster, Inc. | 2009-10-13 |
| RADIANALYZER XPRESS (K092105) | Radi Medical Systems AB | 2009-10-09 |
| AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L) (K092432) | Jawon Medical Co., Ltd. | 2009-10-09 |
| MODEL 6000 TWO PARAMETER BEDSIDE MONITOR (K091787) | Ivy Biomedical Systems, Inc. | 2009-10-09 |
| EP-WORKMATE SYSTEM, VERSION 4.2 (K092810) | St Jude Medical | 2009-10-09 |
| AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770 (K092806) | K-Jump Health Co., Ltd. | 2009-10-09 |
| MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE (K091584) | Merit Medical Systems, Inc. | 2009-10-09 |
| LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 (K090051) | Levitronix, LLC | 2009-10-08 |
| ENGAGE/ENGAGE TR (K092575) | St Jude Medical | 2009-10-08 |
| MAXIFLO, TAPERFLO (K092863) | Vascutek, Ltd. | 2009-10-08 |
| SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER (K092014) | Onset Medical Corporation | 2009-10-08 |
| EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE (K092509) | Edwards Lifesciences, LLC | 2009-10-08 |
| BODY COMPOSITION ANALYZER, MODEL: IOI 353 (K092431) | Jawon Medical Co., Ltd. | 2009-10-08 |
| LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM (K092037) | Hoana Medical, Inc. | 2009-10-02 |
| EVISION DATA MANAGEMENT SOFTWARE (K092678) | Nonin Medical, Inc. | 2009-10-01 |
| CARTO RMT EP NAVIGATION SYSTEM V8 (K091789) | Biosense Webster, Inc. | 2009-10-01 |
| GUARDIAN II HEMOSTASIS VALVE (K092711) | Zerusa Limited | 2009-10-01 |
| FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF (K092161) | Health & Life Co., Ltd. | 2009-09-30 |
| DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LD 1143 (K092683) | Shanghai Little Doctor Co. Limited | 2009-09-25 |
| HI-TORQUE PROGRESS GUIDE WIRE FAMILY (K091825) | Abbott Vascular, Inc. | 2009-09-25 |
| CONDUCTOR CORONARY GUIDEWIRE (K090193) | Concert Medical, LLC | 2009-09-25 |
| NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000 (K090932) | Nexgen Medical Systems, Inc. | 2009-09-24 |
| MILSCOPE FLOATING MASS STETHOSCOPE, MODEL 300-01 (K091972) | Stethoscope Technologies, Inc. | 2009-09-23 |
| ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES (K090989) | Zoll Medical Corp | 2009-09-23 |
| DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING F-CU8 OR F-CU5 (P) MONITOR FRAME OPTIONS AN (K092680) | GE Healthcare Finland Oy | 2009-09-23 |
| HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315 (K092495) | Ev3 Neurovascular | 2009-09-22 |
| DISPOSABLE SPO2 SENSOR M1134A (K091572) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009-09-22 |
| HEALTHANYWHERE SYSTEM (K091220) | Healthanywhere, an Igeacare System Company | 2009-09-21 |
| PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054 (K090752) | Penumbra, Inc. | 2009-09-21 |
| BLOOD PRESSURE MONITOR, MODEL WA400 FOR WRIST TYPE AND MODEL AA300 FOR UPPER ARM TYPE (K091553) | Ningbo Diaier Electronic Co., Ltd. | 2009-09-21 |
| MARKSMANN CATHETER (K091559) | Chestnut Medical Technologies, Inc. | 2009-09-18 |
| MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT (K090450) | Gish Biomedical, Inc. | 2009-09-18 |
| DIGITAL BLOOD PRESSURE MONITOR (K092719) | Shanghai Little Doctor Electronic Co., Ltd. | 2009-09-18 |
| HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS (K091268) | Hospira, Inc. | 2009-09-18 |
| MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT (K090449) | Gish Biomedical, Inc. | 2009-09-18 |
| BELTBEAT WF-400 (K083715) | Bonus Communicaciones Srl | 2009-09-15 |
| HEARTRAIL III GUIDING CATHETER (K092372) | Terumo Corp. | 2009-09-11 |
| ALCATEL-LUCENT TELEHEATH MANAGER (K092635) | Alcatel-Lucent Canada, Inc. | 2009-09-10 |
| SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 (K091808) | Hansen Medical, Inc. | 2009-09-10 |
| POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A (K091943) | Cardiac Science Corporation | 2009-09-10 |
| TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200, DW500,DW700,DW703,DW701M.702M (K091415) | Truly Instrument Co., Ltd. | 2009-09-04 |
| MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM (K092455) | Boston Scientific Corporation | 2009-09-04 |
| TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M (K091434) | Truly Instrument Co., Ltd. | 2009-09-04 |