| SOLAR 9500 INFORMATION MONITOR (K033964) | Ge Medical Systems Information Technologies | 2004-01-15 |
| EASI ECG ALGORITHM (K033513) | Philips Medical Systems | 2004-01-15 |
| D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING (K033323) | Dideco S.P.A. | 2004-01-13 |
| FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH (K033569) | Flowmedica, Inc. | 2004-01-13 |
| BOSTON SCIENTIFIC V-18 CONTROL WIRE (K033742) | Boston Scientific Corp | 2004-01-12 |
| MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM (K033929) | Intra Luminal Therapeutics, Inc. | 2004-01-12 |
| BATTERY PACK, RECHARGEABLE, MODELS MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P (K032051) | Access Battery, Inc. | 2004-01-09 |
| D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS (K033987) | Dideco S.P.A. | 2004-01-08 |
| LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES (K033535) | Lumend, Inc. | 2004-01-07 |
| SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM (K032031) | Intra Luminal Therapeutics, Inc. | 2004-01-07 |
| MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V (K033657) | Living Data Technologies Corporation | 2003-12-19 |
| VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER (K032763) | Vascular Solutions, Inc. | 2003-12-19 |
| HYDROPHILIC GUIDEWIRE (K033758) | Lake Region Mfg., Inc. | 2003-12-19 |
| LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05 (K033159) | LeMaitre Vascular, Inc. | 2003-12-19 |
| MODIFICATION TO UNITY NETWORK ID (K033672) | Ge Medical Systems Information Technologies | 2003-12-18 |
| THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003 (K032920) | Coeur Medical | 2003-12-16 |
| CLEANER II ROTATIONAL THROMBECTOMY SYSTEM (K033793) | Rex Medical | 2003-12-16 |
| TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03 (K031812) | Vascular Control Systems, Inc. | 2003-12-12 |
| PROGREAT (K033583) | Terumo Medical Corp. | 2003-12-12 |
| SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS (K033298) | Masimo Corp. | 2003-12-12 |
| MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING (K033714) | Dideco S.P.A. | 2003-12-11 |
| ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002 (K033424) | Transonic Systems, Inc. | 2003-12-11 |
| INFINITY GAMMAXL (K033600) | Draeger Medical Systems, Inc. | 2003-12-11 |
| M2376A PHILIPS DEVICE LINK SYSTEM (K033680) | Philips Medical Systems | 2003-12-11 |
| GLIDESHEATH (K033681) | Terumo Corp. | 2003-12-11 |
| SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800 (K033641) | Cobe Cardiovascular, Inc. | 2003-12-11 |
| MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM (K033708) | Intra Luminal Therapeutics, Inc. | 2003-12-11 |
| TYTAN PROFESSIONAL /ECONOMY SERIES SPHYGMOMANOMETER, NO 710/NO 700 (K033025) | Tytan Medical Corp. | 2003-12-10 |
| TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 (K031949) | Baylis Medical Co., Inc. | 2003-12-10 |
| MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR (K032841) | Moor Instruments, Ltd. | 2003-12-10 |
| CD LEYCOM PRESSURE/VOLUME CATHETERS (K031599) | Cd Leycom BV | 2003-12-09 |
| MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER (K033613) | Biotronik, Inc. | 2003-12-08 |
| HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF (K032821) | Hygia Health Services, Inc. | 2003-12-05 |
| EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE (K033542) | Galt Medical Corp. | 2003-12-05 |
| MIDA ALGORITHM REV. B (K023414) | Ortivus AB | 2003-12-05 |
| DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE (K032810) | Medtronic Heart Valves | 2003-12-05 |
| LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS (K032900) | Edwards Lifesciences, LLC | 2003-12-04 |
| POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR (K031124) | Datex-Ohmeda, Inc. | 2003-12-04 |
| DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE (K033281) | Datex-Ohmeda | 2003-11-26 |
| RHYTHM DIGITAL ELECTRONIC STETHOSCOPE (K032230) | Thinklabs, Inc. | 2003-11-26 |
| JSA REPROCESSED COMPRESSION SLEEVE DEVICES (K031722) | Jack Speer and Assoc., Inc. | 2003-11-25 |
| DRAEGER MICRO2+ AND MASIMO MINISAT (K032537) | Draeger Medical Systems, Inc. | 2003-11-25 |
| SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO (K031340) | Siemens Medical Solutions USA, Inc. | 2003-11-25 |
| MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065 (K031153) | Arrow Intl., Inc. | 2003-11-25 |
| MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM (K033492) | Ge Medical Systems Information Technologies | 2003-11-24 |
| PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE MULTI-MEASUREMENT SERVER (K033444) | Philips Medical Systems | 2003-11-21 |
| BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER (K033441) | Boston Scientific Corp | 2003-11-21 |
| SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM (K031842) | Intra Luminal Therapeutics, Inc. | 2003-11-21 |
| TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE (K032613) | Peter M. Rothenberg, M.D. | 2003-11-20 |
| COOK CODA BALLOON CATHETER (K032869) | Cook, Inc. | 2003-11-19 |
| TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050 (K033188) | Idev Technologies, Inc. | 2003-11-19 |
| SPEEDLYSER INFUSION CATHETER KIT (K033443) | AngioDynamics, Inc. | 2003-11-19 |
| SCOUT PRO (K033320) | Biotronik, Inc. | 2003-11-19 |
| ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 (K032784) | Intra Luminal Therapeutics, Inc. | 2003-11-18 |
| AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE (K033468) | Medtronic Perfusion Systems | 2003-11-14 |
| SPIROPRO SPO2 (K031515) | Viasys Healthcare GmbH | 2003-11-14 |
| DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES (K033144) | Defibtech, LLC | 2003-11-13 |
| ZOLL AUTOCLAVABLE INTERNAL HANDLES (K032691) | Zoll Medical Corp | 2003-11-13 |
| RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES (K031559) | Renu Medical, Inc. | 2003-11-12 |
| KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS (K033021) | Kimberly-Clark Corp. | 2003-11-12 |
| MODIFICATION TO DASH 3000/4000 PATIENT MONITOR (K033304) | Ge Medical Systems Information Technologies | 2003-11-12 |
| ENDO PAT 2000 (K032519) | Itamar Medical | 2003-11-12 |
| MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100 (K032852) | Revivant Corp. | 2003-11-12 |
| PLANET MONITORING SYSTEM (K032871) | Larsen & Toubro Limited | 2003-11-10 |
| BLOOD PRESSURE MONITOR, MODEL M100 (K032308) | Meditek Technology, Inc. | 2003-11-10 |
| STAR (LUNAR SERIES) MONITORING SYSTEM (K032867) | Larsen & Toubro Limited | 2003-11-10 |
| VITERION 100 TELEHEALTH MONITOR (K030419) | Viterion Telehealthcare, LLC | 2003-11-06 |
| LIFEPAK 12, 20, 500, CR PLUS (K033275) | Medtronic Physio-Control Corp. | 2003-11-06 |
| APEXPRO FH TELEMETRY SYSTEM (K033365) | Ge Medical Systems Information Technologies | 2003-11-06 |
| KD-726 MEMORY WRIST AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K030359) | Kodon(Tianjin)Electronic&Electrical Apparatus Co., | 2003-11-06 |
| ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) (K032439) | Zoll Medical Corp | 2003-11-05 |
| MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM (K033247) | Medrad, Inc. | 2003-11-05 |
| SELECTIVA SB GUIDEWIRE (K033321) | Neometrics, Inc. | 2003-11-05 |
| SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE (K033416) | Medtronic Perfusion Systems | 2003-11-05 |
| EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE (K031946) | Edwards Lifesciences, LLC | 2003-11-03 |
| PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR (K033130) | Osypka Medical, Inc. | 2003-10-31 |
| MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES (K033264) | Medtronic Perfusion Systems | 2003-10-31 |
| ZOLL M SERIES NIBP OPTION (K032363) | Zoll Medical Corp | 2003-10-31 |
| MODIFICATION TO GLOBALCARDIO (K033037) | Cardiocomm Solutions, Inc. | 2003-10-31 |
| GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET (K032426) | Cook, Inc. | 2003-10-31 |
| PHERON PTA CATHETER (K033217) | Biotronik, Inc. | 2003-10-31 |
| KD-622 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K030358) | Kodon(Tianjin)Electronic&Electrical Apparatus Co., | 2003-10-31 |
| AUDICOR UPGRADE SYSTEM (K032145) | Inovise Medical, Inc. | 2003-10-31 |
| JABES ELECTRONIC STETHOSCOPE (K031446) | Gs Technology Co., Ltd. | 2003-10-31 |
| INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM (K033305) | Draeger Medical Systems, Inc. | 2003-10-31 |
| A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS (K032499) | A&D Engineering, Inc. | 2003-10-30 |
| ENDOHELIX ENDARTERECTOMY DEVICE (K032105) | Endarx, Inc. | 2003-10-30 |
| ENSITE SYSTEM (K033211) | Endocardial Solutions, Inc. | 2003-10-30 |
| T-WAVE ALTERNANS (TWA) ALGORITHM OPTION (K032513) | Ge Medical Systems Information Technologies | 2003-10-30 |
| XTRAK SUPPORT CATHETER (K032660) | Xtrak Medical, Inc. | 2003-10-29 |
| TRIVEX SYSTEM (K032387) | Smith & Nephew, Inc. | 2003-10-29 |
| DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE (K033078) | Datex-Ohmeda | 2003-10-29 |
| CENTRA VIEW DEVICE LINK SYSTEM (K033283) | Icu Datasystems, Inc. | 2003-10-27 |
| FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1 (K023723) | Fms, Finapres Medical Systems BV | 2003-10-23 |
| ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110 (K030627) | C.R. Bard, Inc. | 2003-10-23 |
| ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM (K030421) | Alsius Corp. | 2003-10-23 |
| PTA BALLOON CATHETER (K032931) | Cook, Inc. | 2003-10-22 |
| REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH (K032632) | Estech, Inc. | 2003-10-22 |
| ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM (K032312) | Medtronic Vascular | 2003-10-21 |
| NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210 (K032947) | Dolphin Medical, Inc. | 2003-10-17 |