| SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 CITAL SIGNS MONITOR (K082280) | Philips Medical Systems North America Co. | 2008-10-08 |
| ICON, MODEL C3 (K082242) | Osypka Medical, Inc. | 2008-10-08 |
| JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100 (K082664) | Pathway Medical Technologies, Inc. | 2008-10-06 |
| LYMPHA PRESS OPTIMAL, MODEL# 1201AP (K082149) | Mego Afek AC , Ltd. | 2008-10-06 |
| AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR (K081820) | Avalon Laboratories, LLC | 2008-10-06 |
| QUART ARTERIAL FILTER WITH BIOLINE COATING (K082544) | Maquet Cardiopulmonary, AG | 2008-10-03 |
| AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24FR, 26FR, 28FR (K081933) | Avalon Laboratories, LLC | 2008-10-03 |
| IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 (K080825) | Impedimed Pty , Ltd. | 2008-10-03 |
| INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 (K082633) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2008-10-03 |
| GORE TRI-LOBE BALLOON CATHETER (K081799) | W. L. Gore & Associates, Inc. | 2008-10-03 |
| 6F PROXIS SYSTEM (K073700) | St. Jude Medical, Inc. | 2008-10-02 |
| LBI EMBOLECTOMY SYSTEM (K080901) | Lumen Biomedical, Inc. | 2008-10-02 |
| SMARTSIGNS MINPULSE (K081572) | Huntleigh Healthcare , Ltd. | 2008-10-01 |
| ACUNAV V ULTRASOUND CATHETER (K081808) | Siemens Medical Solutions USA, Inc. | 2008-09-26 |
| LIFEBED PATIENT VIGILANCE SYSTEM (K082366) | Hoana Medical, Inc. | 2008-09-26 |
| MODIFICATION TO FETCH ASPIRATION CATHETER (K081989) | Possis Medical, Inc. | 2008-09-26 |
| DUOFLO CATHETER (K080700) | Thermopeutix, Inc. | 2008-09-26 |
| GALAXY 55 (K082685) | Larsen & Toubro Limited | 2008-09-26 |
| LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE (K082256) | Integrated Medical Systems, Inc. | 2008-09-26 |
| FLOWPICC STYLET (K081625) | Vasonova, Inc. | 2008-09-26 |
| MINI GHOST, MODEL: 507 (K082524) | NuMED, Inc. | 2008-09-26 |
| FINECROSS MG CORONARY MICRO-GUIDE CATHETER (K082519) | Terumo Medical Corp. | 2008-09-26 |
| HANDHELD ECG MONITOR, MODEL MD100 (K080933) | Beijing Choice Electronic Technololgy Co., Ltd. | 2008-09-26 |
| AUDICOR SENSOR, MODELS: 2.0, 3.0 (K080602) | Inovise Medical, Inc. | 2008-09-25 |
| T12S TELEMETRY TRANSMITTER (K081800) | Mortara Instrument, Inc. | 2008-09-24 |
| RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER (K082736) | Terumo Medical Corp. | 2008-09-24 |
| HEART SYNC PEDIATRIC, MODEL PED-100 (K081442) | Heart Sync, LLC | 2008-09-24 |
| SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL (K081371) | Leonhard Lang GmbH | 2008-09-24 |
| TANDEMHEART TRANSSEPTAL CANNULA- EF 72 (K082425) | Cardiacassist, Inc. | 2008-09-18 |
| GLIDESHEATH (K082644) | Terumo Medical Corp. | 2008-09-18 |
| ZOLL R SERIES (K081574) | ZOLL Medical Corporation | 2008-09-18 |
| ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-A (K082542) | Cardicare Company, Ltd. | 2008-09-17 |
| REPROCESSED ELECTROPHYSIOLOGY CATHETERS (K082023) | Ascent Healthcare Solutions | 2008-09-16 |
| PTFE INTERLOCK PEELABLE INTRODUCERS (K081394) | Enpath Medical, Inc. | 2008-09-15 |
| PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM) (K082312) | Heartscape Technologies, Ltd. | 2008-09-12 |
| ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32 (K080470) | Maquet Cardiopulmonary, AG | 2008-09-12 |
| FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700 (K081712) | Guangdong Biolight Meditech Co., Ltd. | 2008-09-12 |
| HLM TUBING SET WITH BIOLINE COATING (K080592) | Maquet Cardiopulmonary, AG | 2008-09-11 |
| VASCUTRAK 2, MODELS: V14 AND V18 (K082343) | Ymed, Inc. | 2008-09-11 |
| EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (K081523) | Abbott Vascular-Vascular Solutions | 2008-09-11 |
| ENSITE FUSION DYNAMIC REGISTRATION TOOL (K082467) | St Jude Medical | 2008-09-11 |
| AUDICOR, HEMO AMBULATORY MONITOR (K073545) | Inovise Medical, Inc. | 2008-09-09 |
| RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L (K081659) | Masimo Corporation | 2008-09-09 |
| TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM (K080116) | Transonic Systems, Inc. | 2008-09-08 |
| MICARDIA ANNULOPLASTY BAND DR (K070488) | Micardia Corporation | 2008-09-04 |
| BT3/6, BT12 (K082077) | Corscience GmbH & Co. KG | 2008-09-02 |
| PICOSAT II AND M3002A MULTIMEASUREMENT AND M1020B PLUG-IN MODULES SPO2 PULSE OXIMETRY MODULE (K081937) | Philips Medizin Systeme Boeblingen GmbH | 2008-08-29 |
| MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM (K082186) | Pathway Medical Technologies, Inc. | 2008-08-29 |
| FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR (K081891) | Fukuda Denshi USA, Inc. | 2008-08-29 |
| GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE (K082356) | W. L. Gore & Associates, Inc. | 2008-08-28 |
| CURBELL PATIENT MONITORING CABLES (K081762) | Curbell Electronics, Inc. | 2008-08-27 |
| MICRUS ASCENT OCCLUSION BALLOON CATHETER (K080861) | Micrus Endovascular Corporation | 2008-08-27 |
| ROLL-X GUIDEWIRE (K082304) | St Jude Medical | 2008-08-27 |
| ALLOMAP MOLECULAR EXPRESSION TESTING (DEN080007) | Xdx | 2008-08-26 |
| Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S (K082173) | Cardiac Science Corporation | 2008-08-26 |
| MICRO GUIDE CATHETER XP (K082143) | Cordis Corp. | 2008-08-25 |
| M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00 (K081983) | Philips Medical Systems | 2008-08-22 |
| OHMNISCAN NG (K073334) | Christine Valmy, Inc. | 2008-08-22 |
| CYGNUS 12 LEAD ECG MODULE (K072950) | Cygnus, LLC | 2008-08-22 |
| RX ACCUNET LP EMBOLIC PROTECTION SYSTEM (K081549) | Abbott Laboratories | 2008-08-19 |
| INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER (K082061) | Irvine Biomedical, Inc. | 2008-08-19 |
| CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080 (K082191) | Cardiomems, Inc. | 2008-08-19 |
| AXIUM DETACHABLE COIL SYSTEM (K081465) | Micro Therapeutics, Inc. | 2008-08-19 |
| HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER (K082075) | Hansen Medical, Inc. | 2008-08-15 |
| TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXX (K080189) | Trimline Medical Products Corp. | 2008-08-15 |
| ANEROID SPHYGMOMANOMETER, MODEL KT-A01 (K081951) | Wenzhou Kindcare Import & Export Co., Ltd. | 2008-08-15 |
| MODIFICATION TO MERCI RETRIEVER (K082034) | Concentric Medical, Inc. | 2008-08-15 |
| SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR (K081365) | St Jude Medical | 2008-08-15 |
| MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM (K081944) | Cardio Systems, Inc. | 2008-08-14 |
| SOLEX CATHETER, MODEL SL2593 (K081936) | Alsius Corp. | 2008-08-13 |
| POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS (K080637) | Stereotaxis, Inc. | 2008-08-12 |
| ANGIOSCULPT PTA SCORING BALLOON CATHETER (K082059) | Angioscore, Inc. | 2008-08-11 |
| FINDRWIRZ GUIDE WIRE SYSTEM (K080364) | Sentreheart, Inc. | 2008-08-11 |
| HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES (K081159) | Harvard Medical Devices , Ltd. | 2008-08-08 |
| APPROACH CTO WIRE GUIDE (K081337) | Cook Incorporated | 2008-08-08 |
| KINETIX GUIDEWIRE, PLUS GUIDEWIRE (K081021) | Boston Scientific Corp | 2008-08-08 |
| MIRAFLEX HIGH FLOW MICROCATHETER (K080737) | Cook, Inc. | 2008-08-08 |
| ARCTIC BLAST INTRAVENOUS FLUID CHILLER (K080899) | Medivance, Inc. | 2008-08-07 |
| PIONEER PLUS CATHETER (K081804) | Medtronic, Inc. | 2008-08-05 |
| INTERCEPTOR PLUS CORONARY FILTER SYSTEMS (K073523) | Medtronic, Inc. | 2008-08-01 |
| MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 (K082045) | Spacelabs Medical, Inc. | 2008-08-01 |
| STATMAP, MODEL 7200 (K072109) | Ramsey Medical, Inc. | 2008-07-31 |
| SKYLINE 55 (K081552) | Larsen & Toubro Limited | 2008-07-31 |
| BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM (K081444) | Braemar, Inc. | 2008-07-31 |
| KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K080326) | Andon Health Co, Ltd. | 2008-07-31 |
| MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO (K081870) | GE Healthcare Finland Oy | 2008-07-31 |
| STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER (K080832) | Sorin Group Deutschland GmbH | 2008-07-30 |
| G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS (K080668) | C.R. Bard, Inc. | 2008-07-30 |
| LIFEPAK 20E (K073089) | Physio-Control, Inc. | 2008-07-29 |
| REPROCESSED MASIMO PULSE OXIMETER SENSORS (K081238) | Ascent Healthcare Solutions | 2008-07-29 |
| VALVULOTOME BY KOVEN (K080178) | Koven Technology, Inc. | 2008-07-28 |
| T-STAT 303 ISCHEMIA MONITORING SYSTEM (K081233) | Spectros Corporation | 2008-07-28 |
| MICROSHEATH LP AND LP-AT (K080849) | Flowcardia, Inc. | 2008-07-25 |
| SOLARIS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES (K073249) | Solaris Medical Technology, Inc. | 2008-07-25 |
| CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM (K081776) | Omega Critical Care Limited | 2008-07-22 |
| MODIFIED HD GUIDE CATHETER (K080583) | Concentric Medical, Inc. | 2008-07-18 |
| VISENSIA (K081140) | Obs Medical | 2008-07-17 |
| PATHWAY PV ATHERECTOMY SYSTEM (K081328) | Pathway Medical Technologies, Inc. | 2008-07-17 |
| MAC 1600 ECG ANALYSIS SYSTEM (K081437) | Ge Medical Systems Information Technologies | 2008-07-15 |
| STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS (K080982) | Boston Scientific Corp | 2008-07-14 |