| QUATTRO CATHETER MODEL IC4593 (K070161) | Alsius Corp. | 2007-02-15 |
| VASCUPUNCTURE PICC GUIDEWIRE (K070150) | Neometrics, Inc. | 2007-02-15 |
| BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230 (K062603) | Biospace Corporation Limited | 2007-02-15 |
| SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING (K062569) | Datascope Corp. | 2007-02-14 |
| INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0 (K062894) | Dailycare Biomedical, Inc. | 2007-02-08 |
| MP5 INTELLIVUE PATIENT MONITOR (K063725) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007-02-08 |
| STARCLOSE HEX-HUB DILATOR (K062554) | Abbott Vascular, Inc. | 2007-02-06 |
| XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VASCULAR 5, PATIENT CARE CONSOLE AND CENTRAL STATION (K063840) | Witt Biomedical Corp | 2007-02-06 |
| SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX (K062098) | Datascope Corp. | 2007-02-05 |
| KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A (K062893) | Shanghai Kodea Economic and Trade Development , Ltd. | 2007-02-05 |
| FINOMETER MODEL-2 WITH ACCESSORIES (K063111) | Finapres Medical Systems B.V. | 2007-02-01 |
| SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101 (K061931) | Solaris Medical Technology, Inc. | 2007-01-31 |
| ASAHI PTCA GUIDE WIRE, FIELDER FC (K063819) | Asahi Intecc Co., Ltd. | 2007-01-26 |
| LIFEPAK 12 DEFIBRILLATOR/MONITOR (K063510) | Medtronic Emergency Response Systems, Inc. | 2007-01-26 |
| SENTINEL (K062397) | Del Mar Reynolds Medical, Ltd. | 2007-01-25 |
| PHASE 3, MODEL DT-1 (K062099) | Datrend Systems, Inc. | 2007-01-25 |
| MOORFLPI FULL-FIELD LASER PERFUSION IMAGER (K063586) | Moor Instruments, Ltd. | 2007-01-25 |
| MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6 (K063774) | Concentric Medical, Inc. | 2007-01-24 |
| THERMOGARD THERMAL REGULATION SYSTEM (K063829) | Alsius Corp. | 2007-01-22 |
| TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM (K063434) | Radiometer Basel AG | 2007-01-22 |
| LUNDERQUIST WIRE GUIDE; DC WIRE GUIDE (K061670) | William Cook Europe Aps | 2007-01-19 |
| RADIFOCUS GLIDEWIRE ADVANTAGE (K063372) | Terumo Medical Corp. | 2007-01-19 |
| MODIFIED MERCI RETRIEVER, MODEL 90050 (K062046) | Concentric Medical, Inc. | 2007-01-19 |
| SPIDERFX EMBOLIC PROTECTION DEVICE (K063785) | Ev3, Inc. | 2007-01-19 |
| MOORLDLS LASER DOPPLER LINE SCANNER (K063561) | Moor Instruments, Ltd. | 2007-01-19 |
| THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02 (K062868) | Flowcardia, Inc. | 2007-01-19 |
| A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR (K062027) | A&D Engineering, Inc. | 2007-01-19 |
| TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230 (K062877) | Vascular Solutions, Inc. | 2007-01-18 |
| PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PRI-MAP-20, PRI-MAP-25 (K061678) | Prorhythm | 2007-01-12 |
| VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL) (K063217) | B.Braun Medical, Inc. | 2007-01-12 |
| HEARTSTART MRX, MODELS M3535A OR M3536A (K063375) | Philips Medical Systems | 2007-01-11 |
| D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED (K063255) | Sorin Group Italia S.R.L. | 2007-01-11 |
| REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM (K063405) | Radiant Medical | 2007-01-08 |
| DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM (K063525) | Datascope Corp. | 2007-01-05 |
| INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905 (K062627) | Vascular Solutions, Inc. | 2007-01-05 |
| MODIFICATION TO HEALTH BUDDY APPLIANCE (K063612) | Health Hero Network, Inc. | 2006-12-29 |
| RAINBOW ADHESIVE CO-OXIMETRY SENSORS (K063140) | Masimo Corporation | 2006-12-29 |
| INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR (K062652) | Tanita Corporation of America | 2006-12-28 |
| CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM (K062265) | Swiss Medical Care S.A. | 2006-12-26 |
| PATIENT DATA HANDLER & DEVICES (PDH&D) (K063484) | Intermed Advisors, Inc. | 2006-12-22 |
| LIFEPAK 20 DEFIBRILLATOR/ MONITOR (K063119) | Medtronic Emergency Response Systems, Inc. | 2006-12-22 |
| VS-800 VITAL SIGNS MONITOR (K063055) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006-12-21 |
| CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM (K063547) | Witt Biomedical Corp | 2006-12-21 |
| AUTOPULSE RESUSCITATION SYSTEM MODEL100 (K063602) | Zoll Circulation | 2006-12-21 |
| ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX (K063182) | Enpath Medical, Inc. | 2006-12-21 |
| FLIPPER DETACHABLE EMBOLIZATION COILS (K063619) | Cook, Inc. | 2006-12-20 |
| V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC (K062577) | Tz Medical, Inc. | 2006-12-15 |
| ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER (K061680) | Atrium Medical Corp. | 2006-12-15 |
| PRONTO V3 EXTRACTION CATHETER, MODEL 5003 (K063371) | Vascular Solutions, Inc. | 2006-12-14 |
| SUPRACOR BALLOON CATHETER (K062582) | Abiomed, Inc. | 2006-12-14 |
| ZOLL E SERIES WITH REAL CPR HELP (K062177) | ZOLL Medical Corporation | 2006-12-13 |
| REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351 (K052465) | Heartsine Technologies, Inc. | 2006-12-12 |
| VASCUTRAK PTA DILATION CATHETER (K063657) | Ymed, Inc. | 2006-12-12 |
| ORI F6T DRY ECG MONITORING ELECTRODE (K062760) | Orbital Research, Inc. | 2006-12-11 |
| MODIFICATION TO MODEL 750 SERIES MONITOR (K063087) | Cas Medical Systems, Inc. | 2006-12-11 |
| COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1 (K061902) | Inditherm Medical | 2006-12-08 |
| PRN THERMALCARE, MODEL 3000 (K062794) | American Healthcare Products, Inc. | 2006-12-07 |
| MODIFICATION TO: SMITHWICK CAROTID SHUNT (K061484) | Mcpherson Enterprises, Inc. | 2006-12-07 |
| MERCATOR MICROSYRINGE II INFUSION CATHETER (K062752) | Mercator Medsystems, Inc. | 2006-12-07 |
| BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM (K051817) | Cardiva Medical, Inc. | 2006-12-06 |
| I-SCOPE 200 (K062364) | Dongjin Medical Co., Ltd. | 2006-12-06 |
| MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN (K062324) | GE Healthcare | 2006-12-06 |
| FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM) (K063313) | Boston Scientific Corp | 2006-12-05 |
| NEUROWAVE MICRO-INFUSION SYSTEM (K062508) | Ekos Corp. | 2006-12-05 |
| MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 ) (K063419) | Welch Allyn Protocol, Inc. | 2006-12-04 |
| PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 (K062769) | Radi Medical Systems AB | 2006-12-04 |
| VASOPRESS DVT SYSTEM, MODEL VP500D (K061814) | Compression Therapy Concepts, Inc. | 2006-11-30 |
| M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170) (K062271) | Philips Medical Systems | 2006-11-30 |
| MAPMATE (K063277) | Ep Medsystems, Inc. | 2006-11-30 |
| MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942 (K063312) | Boston Scientific Corp | 2006-11-30 |
| HEARTSTART MRX MONITOR/DEFIBRILLATOR (K062233) | Philips Medical Systems North America, Inc. | 2006-11-22 |
| ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120 (K061951) | Possis Medical, Inc. | 2006-11-22 |
| MICRO-INFUSION SYSTEM (K062507) | Ekos Corp. | 2006-11-22 |
| TELEMEDICINE SYSTEM MODEL VMS-01 (K062662) | Medic4all (Israel) , Ltd. | 2006-11-21 |
| INTELLIVUE PATIENT MONITORS, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 (K063315) | Philips Medizin Systeme Boeblingen GmbH | 2006-11-20 |
| ASAHI PRECIOUS GUIDE CATHETER (K061601) | Asahi Intecc Co., Ltd. | 2006-11-17 |
| ELI 350 ELECTROCARDIOGRAPH (K062677) | Mortara Instrument, Inc. | 2006-11-15 |
| TENACORE SP02 SENSORS (K053420) | Tenacore Holdings, Inc. | 2006-11-15 |
| ATB ADVANCED PTA DILATATION CATHETER (K063252) | Cook, Inc. | 2006-11-14 |
| SPIDERFX EMBOLIC PROTECTION DEVICE (K063204) | Ev3, Inc. | 2006-11-14 |
| CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004 (K063222) | Cardionet, Inc. | 2006-11-14 |
| SMITHWICK CAROTID SHUNT (K062474) | Mcpherson Enterprises, Inc. | 2006-11-09 |
| ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J (K062186) | Asahi Intecc Co., Ltd. | 2006-11-09 |
| GORE PROPATEN VASCULAR GRAFT (K062161) | W. L. Gore & Associates, Inc. | 2006-11-09 |
| PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T (K062605) | Philips Medical Systems | 2006-11-09 |
| MEDIC4ALL TELEMEDICINE SYSTEM, MODEL VMS-01 (NIBP) (K062127) | Medic4all (Israel) , Ltd. | 2006-11-08 |
| SENSACARE SAW-102 WRIST DIGITAL BLOOD PRESSURE MONITOR (K061935) | Sensacare , Ltd. | 2006-11-08 |
| HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0 (K061905) | Medcon , Ltd. | 2006-11-08 |
| HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1 (K061848) | Hypermed, Inc. | 2006-11-08 |
| HEPASPHERE MICROSPHERES (K052742) | Biosphere Medical, Inc. | 2006-11-07 |
| BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500 (K062043) | Omron Healthcare, Inc. | 2006-11-07 |
| VOYAGER 12 (K062469) | Del Mar Reynolds Medical, Ltd. | 2006-11-03 |
| EQUIVITAL, MODEL EQ-01 (K061993) | Hidalgo Limited | 2006-11-03 |
| PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL (K062455) | Philips Medical Systems | 2006-11-03 |
| TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA (K062597) | Terumo Cardiovascular Systems Corp. | 2006-11-03 |
| OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN (K062999) | Hospira, Inc. | 2006-11-03 |
| MEDLOG, MODEL 1-0-10 (K060756) | Bmc Gesellschaft Fur Medizintechnik Mbh | 2006-10-30 |
| INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0 (K062068) | Intelwave, LLC | 2006-10-27 |
| EP-WORKMATE (K063113) | Ep Medsystems | 2006-10-27 |
| MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F (K062887) | Bard Peripheral Vascular | 2006-10-26 |