| MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K031330) | Masimo Corp. | 2003-05-12 |
| DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (K030417) | Philips Medical Systems | 2003-05-09 |
| HERO (K021230) | Medical Decision Networks | 2003-05-09 |
| PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2 (K023338) | Fms, Finapres Medical Systems BV | 2003-05-09 |
| C3 PATIENT MONITOR (K030931) | Analogic Corp. | 2003-05-09 |
| MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODELS HPL-100 AND HPL-100A (K030561) | Mytech Technology Co., Ltd. | 2003-05-09 |
| CARDIOVASCULAR SONOSPECTROGRAPHIC ANALYZER (K023759) | Sonomedica | 2003-05-06 |
| EK-PRO ARRHYTHMIA DETECTION ALGORITHM (K031320) | Ge Medical Systems Information Technologies | 2003-05-06 |
| REPROCESSED ELECTROPHYSIOLOGY CATHETER (K030026) | Alliance Medical Corp. | 2003-05-02 |
| CARECOMPANION PATIENT STATION/CARECOMPANION PATIENT STATION (K023286) | Neptec Design Group, Ltd. | 2003-05-02 |
| HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945 & BFM 960 (K030349) | Bonso Electronics International, Inc. | 2003-05-02 |
| SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR (K031223) | Dideco S.P.A. | 2003-05-02 |
| ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR (K021174) | Imagyn Surgical | 2003-04-29 |
| CARBODISSECTING ENDOSCOPE (K020925) | Endo Surgical Devices, Inc. | 2003-04-29 |
| 5F MEDTRONIC LAUNCHER GUIDE CATHETER (K030779) | Medtronic Vascular | 2003-04-24 |
| ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP (K023205) | Biotronik, Inc. | 2003-04-24 |
| SAFFRON NM GUIDING CATHETER (K030715) | Neich Medical (Shenzhen) Company Limited | 2003-04-24 |
| EDWARDS INTRODUCER SHEATH (K031087) | Edwards Lifesciences, LLC | 2003-04-24 |
| HL888JF (K030541) | Health & Life Co., Ltd. | 2003-04-24 |
| SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14, SAFE CROSS ANGLED SUPPORT CATHETER, SAFE CROT (K030984) | Intra Luminal Therapeutics, Inc. | 2003-04-24 |
| VTI 20 MHZ GATED DOPPLER (K031091) | Vascular Technology Incorporated | 2003-04-23 |
| STEELEX ELECTRODE SET (K030556) | Aesculap, Inc. | 2003-04-22 |
| MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 (K030129) | Endocardial Solutions, Inc. | 2003-04-22 |
| LONG WELL LW-6DXX SERIES BODY FAT ANALYZER (K030203) | Long Well Electronics Corp. | 2003-04-21 |
| CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON (K030231) | Sorin Group Italia S.R.L. | 2003-04-18 |
| PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE (K021421) | Tz Medical, Inc. | 2003-04-18 |
| VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100 (K030613) | Criticare Systems, Inc. | 2003-04-17 |
| HL888HM (K030499) | Health & Life Co., Ltd. | 2003-04-17 |
| RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE) (K030696) | Medtronic Perfusion Systems | 2003-04-11 |
| HL888HA (K030498) | Health & Life Co., Ltd. | 2003-04-11 |
| GOLDWAY PATIENT MONITOR, MODEL # UT4000F (K021154) | Goldway Us, Inc. | 2003-04-11 |
| EPTFE VASCULAR PROSTHESIS; SEALPTFE (K030999) | Vascutek, Ltd. | 2003-04-09 |
| MEDAMICUS FLOWGUARD PEELABLE INTRODUCER (K030905) | Medamicus, Inc. | 2003-04-09 |
| ENVAN HEART RATE MONITOR (K030656) | Envan, LLC | 2003-04-08 |
| STEREOTAXIS CATHETER ADVANCER SYSTEM (K021802) | Stereotaxis, Inc. | 2003-04-08 |
| MICROCAP PLUS/NPB-75 (K024300) | Oridion Medical 1987 , Ltd. | 2003-04-03 |
| IVS INTRODUCER SET, MODEL 1003 (K030723) | Integrated Vascular Systems, Inc. | 2003-04-03 |
| ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, ADL0820-135,ADL0920-80,ADL0920-135,ADL1020-0 (K030062) | Avantec Vascular Corp. | 2003-04-03 |
| VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING (K023381) | Gish Biomedical, Inc. | 2003-03-31 |
| IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR (K030154) | Dideco S.P.A. | 2003-03-31 |
| GISH ARTERIAL FILTER WITH GBS COATING (K023833) | Gish Biomedical, Inc. | 2003-03-31 |
| ECHELON MICRO CATHETER, MODEL 105-5092-150 (K030688) | Micro Therapeutics, Inc. | 2003-03-28 |
| ER800 SERIES ECG EVENT RECORDER (K030856) | Braemar Corp. | 2003-03-28 |
| VERMED A10021 RESTING EKG TAB ELECTRODE (K030073) | Vermont Medical, Inc. | 2003-03-28 |
| MPM-NET (K030825) | Aerotel Medical Systems (1998) , Ltd. | 2003-03-28 |
| REPROCESSED PULSE OXIMETER SENSORS (K012677) | Sterilmed, Inc. | 2003-03-28 |
| MODIFICATION TO EXPORT ASPIRATION CATHETER (K030201) | Medtronic Vascular | 2003-03-26 |
| SETPOINT ENDOVASCULAR TEMPERATURE PROBE (K024327) | Radiant Medical | 2003-03-25 |
| LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100 (K020271) | Levitronix, LLC | 2003-03-25 |
| SIEMENS INFINITY GATEWAY SUITE, MODEL VF2 (K030657) | Siemens Medical Solutions | 2003-03-21 |
| INFINITY EXPLORER (K030615) | Siemens Medical Solutions USA, Inc. | 2003-03-21 |
| M2376A DEVICELINK SYSTEM (K030731) | Philips Medical Systems, Inc. | 2003-03-21 |
| MODIFICATION TO SOLAR 9500 INFORMATION MONITOR (K030575) | Ge Medical Systems Information Technologies | 2003-03-21 |
| VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K030114) | Vanguard Medical Concepts, Inc. | 2003-03-21 |
| BPTRU VITAL SIGNS MONITOR, MODEL BPM-300, & BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE AND TEMPERATURE MONITOR (K023078) | Vsm Medtech , Ltd. | 2003-03-21 |
| ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH (K022947) | Terumo Cardiovascular Systems Corp. | 2003-03-20 |
| VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES (K030005) | Vanguard Medical Concepts, Inc. | 2003-03-18 |
| DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER (K024235) | Dolphin Medical, Inc. | 2003-03-17 |
| GISH TUBING AND CONNECTORS WITH GBS COATING (K030077) | Gish Biomedical, Inc. | 2003-03-14 |
| CPCA2000 COUNTERPULSATION SYSTEM (K030532) | Cpca2000, Inc. | 2003-03-14 |
| PHILIPS MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS WITH PORTAL TECHNOLOGY AND M3185 OPT C41 WIRELESS BEDSIDE ADAPTR (K030038) | Philips Medical Systems, Inc. | 2003-03-12 |
| CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1 (K022004) | Biosensors International-USA | 2003-03-12 |
| REPROCESSED COMPRESSION SLEEVES (K024087) | Alliance Medical Corp. | 2003-03-11 |
| MODIFIED CONCENTRIC RETRIEVER, MODEL 90037 (K030476) | Concentric Medical, Inc. | 2003-03-11 |
| DELWA-STAR WS-FM BLOOD PRESSURE AND BODY FAT MONITOR (K024077) | Zewa, Inc. | 2003-03-10 |
| REPROCESSED COMPRESSION SLEEVES (K024074) | Alliance Medical Corp. | 2003-03-07 |
| NAUTICA MICRO CATHETER, MODEL 105-5094-153 (K024122) | Micro Therapeutics, Inc. | 2003-03-07 |
| IM2001 PULSE OXIMETER (K012706) | Imagyn Medical Technologies, Inc. | 2003-03-07 |
| COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700 (K030462) | Cobe Cardiovascular, Inc. | 2003-03-06 |
| SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING (K024065) | Gish Biomedical, Inc. | 2003-03-05 |
| MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR (K030449) | Terumo Corp. | 2003-03-05 |
| SKINTACT ECG TAB ELECTRODE (K030509) | Leonhard Lang GmbH | 2003-03-04 |
| ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A (K030105) | Nihon Kohden America, Inc. | 2003-03-04 |
| CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMEN (K030524) | Cd Leycom BV | 2003-03-03 |
| MODIFICATION TO DASH 3000/4000 PATIENT MONITOR (K030431) | Ge Medical Systems Information Technologies | 2003-02-26 |
| QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030 (K030264) | Jostra AG | 2003-02-26 |
| TYTAN ELECTRONIC STETHOSCOPES (MODEL #600) (K023637) | Tytan Medical Corp. | 2003-02-26 |
| MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100 (K030141) | Cardiovention, Inc. | 2003-02-26 |
| CLOCKMINI, MODEL DF301; CLOCKNAVI, MODEL DF311 (K023942) | Yamato Corp. | 2003-02-24 |
| COAXIA FLOCONTROL CATHETER (K023914) | Coaxia, Inc. | 2003-02-21 |
| GELBFISH FLEX VASCULAR DILATOR (K030260) | Vascumetrix, LLC | 2003-02-20 |
| MAGIC INFUSION CATHETER (K023351) | Advanced Interventional Technologies, LLC | 2003-02-20 |
| CVSI PERIPHERAL BALLOON CATHETER; CVSI CATHETER INFLATION UNIT (K023463) | Cryo Vascular Systems, Inc. | 2003-02-19 |
| MCPULSE (K023238) | Meridian Co., Ltd. | 2003-02-19 |
| TRAVELAIR PORTABLE COMPRESSION SYSTEM (K022340) | Dynamic Air, Inc. | 2003-02-19 |
| SAMARITAN AED, MODEL SAM-01 (K023854) | Heartsine Technologies, Inc. | 2003-02-14 |
| STEERABLE GUIDEWIRE (K022813) | Lake Region Mfg., Inc. | 2003-02-14 |
| GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM (K024071) | Guidant Corporation, Cardiac Surgery | 2003-02-14 |
| EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000 (K022071) | Embol-X, Inc. | 2003-02-14 |
| WELCH ALLYN VITAL SIGN MONITOR WITH MP506 (K024005) | Welch Allyn, Inc. | 2003-02-12 |
| MINOLTA PULSOX-2 (K021469) | Konica Minolta Sensing, Inc. | 2003-02-12 |
| A16 BLOOD FLOW MEASUREMENT SYSTEM (K023707) | D. E. Hokanson, Inc. | 2003-02-12 |
| SIEMENS INFINITY SC 6002XL MODIFICATIONS (K030313) | Siemens Medical Solutions USA, Inc. | 2003-02-11 |
| MEDSTAR SYSTEM, MODELS 533-300 (K020534) | Cybernet Medical | 2003-02-11 |
| VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017 (K023800) | Aircast, Inc. | 2003-02-10 |
| ALLON 2001 VERSION 5 (K024128) | Mtre Advanced Technology , Ltd. | 2003-02-10 |
| REPROCESSED COMPRESSION SLEEVE (K021654) | Alliance Medical, Inc. | 2003-02-05 |
| RADIUS MICRO SNARE (K022201) | Radius Medical Technologies, Inc. | 2003-02-03 |
| ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066 (K024118) | Micro Therapeutics, Inc. | 2003-02-03 |
| PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB (K024053) | Oscor, Inc. | 2003-01-31 |