| FLO-THRU (K981624) | Bio-Vascular, Inc. | 1998-08-04 |
| CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER (K981601) | Sorin Group Italia S.R.L. | 1998-07-28 |
| CT 100 ELECTROCARDIOGRAPH (K981951) | Macquarie Medical Systems | 1998-07-28 |
| 3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360 (K974445) | 3M Healthcare | 1998-07-26 |
| MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM (K982232) | Irvine Biomedical, Inc. | 1998-07-25 |
| BALADI INVERTER WITH COAXIAL AORTIC PUNCH (K980128) | Cardio Medical Solutions, Inc. | 1998-07-24 |
| CORE AND COIL ASSEMBLY GUIDEWIRE (K971322) | Lake Region Mfg., Inc. | 1998-07-22 |
| RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000 (K981083) | Biotronik, Inc. | 1998-07-22 |
| MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A (K981576) | Hewlett-Packard GmbH | 1998-07-17 |
| BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX (K981745) | Sunscope Intl., Inc. | 1998-07-17 |
| Squirt Fluid Delivery System (K981417) | Merit Medical Systems, Inc. | 1998-07-17 |
| OSCILLOMATE NIBP / SP02 EMS MONITOR (K980879) | Cas Medical Systems, Inc. | 1998-07-16 |
| ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING PRODUCT FAMILY MODELS 1003211H,1003212HJ,1003213H,1 (K981381) | Guidant Corp. | 1998-07-15 |
| AVIVA SYSTEMS MODEL NUMBERS 1010, 2020 (K981533) | American Telecare, Inc. | 1998-07-15 |
| HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER (K974736) | Heartport, Inc. | 1998-07-15 |
| LAKE REGION MANUFACTURING GUIDEWIRES (K981326) | Lake Region Mfg., Inc. | 1998-07-10 |
| HEART CATH TRAY, STERILE, DISPOSABLE (K981441) | Trinity Laboratories, Inc. | 1998-07-10 |
| DEGANIA SILICONE IDENTI LOOPS (K981956) | Degania Silicone , Ltd. | 1998-07-09 |
| SIEMENS SC9000/SC9015 ENHANCED WITH 12-LEAD ST SEGMENT ANALYSIS (K974698) | Siemens Medical Solutions USA, Inc. | 1998-07-08 |
| CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER (K972899) | Cypress Medical Products, Ltd. | 1998-07-07 |
| CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM (K980487) | Baxter Edwards | 1998-07-07 |
| PRESDURE PRODUCTS PRESSURE PADS, MODELS P100, P110, P120, P130, P200, P210, P220, P230, P300, P310, P320, P330 (K980087) | Pressure Products, Inc. | 1998-07-01 |
| CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETER (K971975) | Cardima, Inc. | 1998-07-01 |
| MRI COMPATIBLE MONITOR AND ACCESSORIES (K980362) | Datex-Engstrom, Inc. | 1998-06-30 |
| MODIFICATION FOR PTA BALLOON CATHETER (K981906) | Cook, Inc. | 1998-06-29 |
| PASSPORT 5L-CE MODEL 0998-00-0131XXX (K974178) | Datascope Corp. | 1998-06-26 |
| LIFE SUPPORT FOR TRAUMA AND TRANSPORT (K965117) | Northrop Grumman Corp. | 1998-06-26 |
| CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER (K973298) | Cardima, Inc. | 1998-06-26 |
| FUKUDA DENSHI DYNASCOPE MODEL DS-5000 SERIES TELEMETRY SYSTEM (K980728) | Fukuda Denshi USA, Inc. | 1998-06-19 |
| OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER (K973013) | Vas-Cath, Inc. | 1998-06-19 |
| KOALA VASCULAR CLAMPS AND INSERTS (K980002) | Boss Instruments, Ltd. | 1998-06-18 |
| EASY RIDER MICRO CATHETER (K974473) | Micro Therapeutics, Inc. | 1998-06-17 |
| HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER (K980144) | Aerotel, Ltd. | 1998-06-16 |
| COSGROVE CLAMP (K974769) | Allegiance Healthcare Corp. | 1998-06-12 |
| BODYSTAT DUALSCAN 2005 (K980971) | Bodystat , Ltd. | 1998-06-11 |
| ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4000 (K964153) | Rossmax International , Ltd. | 1998-06-11 |
| KAPLAN-SIMPSON INFUSASLEEVE II (K980957) | Localmed, Inc. | 1998-06-10 |
| THE AMPLANTZ GOOSE NECK MICROSNARE (K970668) | Microvena Corp. | 1998-06-10 |
| NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES (K974292) | Nihon Kohden America, Inc. | 1998-06-08 |
| SIEMENS SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR (K980882) | Siemens Medical Solutions USA, Inc. | 1998-06-05 |
| IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U (K970689) | Arrow Intl., Inc. | 1998-06-04 |
| BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS (K980850) | C.R. Bard, Inc. | 1998-06-03 |
| SHELHIGH NO-REACT PERICARDIAL PATCHES (K974914) | Shelhigh, Inc. | 1998-06-03 |
| CS/3(TM) MONITORS* (K974792) | Datex-Engstrom, Inc. | 1998-06-02 |
| COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR (K974812) | Cobe Cardiovascular, Inc. | 1998-06-01 |
| DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES (K980780) | Datascope Corp. | 1998-05-29 |
| CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04. (K980961) | Cordis Webster, Inc. | 1998-05-28 |
| PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT (K974285) | Perimed, Inc. | 1998-05-28 |
| SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496 (K972502) | Spacelabs Medical, Inc. | 1998-05-28 |
| MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD (K973360) | Medtronic Vascular | 1998-05-26 |
| FAST-CATH (TM) INTRA-CARDIAC INTRODUCER (K973840) | Daig Corp. | 1998-05-21 |
| OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER (K981407) | Cordis Corp. | 1998-05-20 |
| SIEMENS MULTIVIEW WORKSTATION ENHANCED WITH DIAGNOSTIC STATEMENTS (REST ECG) (K980625) | Siemens Medical Solutions USA, Inc. | 1998-05-19 |
| CRITIKON SOFT BLOOD PRESSURE CUFF (K974080) | Johnson & Johnson Medical, Inc. | 1998-05-18 |
| SITESEER ANGIOGRAPHIC CATHETER (K980575) | C.R. Bard, Inc. | 1998-05-15 |
| 3M CDI QUICK-CELLS WITH HEPARIN TREATMENT (K980732) | 3M Healthcare | 1998-05-15 |
| BARD ISOFLOW BLOOD PUMP (K971421) | C.R. Bard, Inc. | 1998-05-14 |
| CAPIOX SX HARDSHELL RESERVOIR (K980935) | Terumo Medical Corp. | 1998-05-14 |
| SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS (K981413) | Boston Scientific Scimed, Inc. | 1998-05-13 |
| MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE (K980857) | Graphic Controls Corp. | 1998-05-12 |
| CORDIS VANGUARD STEERABLE GUIDEWIRES (K974560) | Cordis Corp. | 1998-05-11 |
| CARDIOSTATION (K980624) | Universal Medical, Inc. | 1998-05-11 |
| VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT (K981079) | Impra, Inc. | 1998-05-07 |
| VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT (K981076) | Impra, Inc. | 1998-05-07 |
| OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR (K972020) | Cas Medical Systems, Inc. | 1998-05-05 |
| JOBST ATHROMBIC PUMP SYSTEM 2600 (K980456) | Jobst A Beiersdorf Co. | 1998-05-05 |
| DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES (K980385) | Datascope Corp. | 1998-05-01 |
| E100 SERIES SPO2 SENSORS (K970098) | Epic Medical Equipment Services, Inc. | 1998-04-30 |
| MOOORLDI LASER DOPPLER IMAGER (K980383) | Moor Instruments, Ltd. | 1998-04-30 |
| DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H (K980534) | The Heart Valve Div. Medtronic Cardiovascular Surg | 1998-04-30 |
| MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR (K970211) | Micro Weiss Electronics | 1998-04-30 |
| MICROLIFE MANUAL BLOOD PRESSURE MONITOR (MANUAL INFLATE) MODEL BP-2BIO (K970139) | Micro Weiss Electronics | 1998-04-30 |
| SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES (K980360) | Scimed Life Systems, Inc. | 1998-04-29 |
| EASY ECG PC BASED ELECTROCARDIOGRAPH (K972996) | Ates Medical S.R.L. | 1998-04-28 |
| CSS-CARDIOPLEGIA SAFETY SYSTEM (K973237) | Medtronic Bio-Medicus, Inc. | 1998-04-27 |
| URESIL DILATOR WITH RADIOPAQUE MARKER (K980282) | Uresil Corp. | 1998-04-24 |
| PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE (K972793) | Radi Medical Systems AB | 1998-04-24 |
| APEX OXIMETER (K980299) | Marquette Medical Systems, Inc. | 1998-04-24 |
| ACS HI-TORQUE SUPER SPORT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING (K980294) | Guidant Corp. | 1998-04-24 |
| CS/3 ARRHYTHMIA WORKSTATION (K974747) | Datex-Engstrom, Inc. | 1998-04-23 |
| FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP, FEMOSTOP II BILATERAL ADAPTER (K980898) | Radi Medical Systems AB | 1998-04-21 |
| HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER (K971504) | J-Lloyd Medical, Inc. | 1998-04-20 |
| ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC. (K973639) | J-Lloyd Medical, Inc. | 1998-04-20 |
| PTA BALLOON CATHETER (K972800) | Cook, Inc. | 1998-04-16 |
| PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE (K972201) | Sulzer Carbomedics, Inc. | 1998-04-14 |
| ENVOY PATIENT MONITOR (K974510) | Mennen Medical, Inc. | 1998-04-14 |
| CH-611B AND CH-611C DIGITAL WRIST SPHYGMOMANOMETERS BLOOD PRESSURE METER (K973613) | Foley & Lardner | 1998-04-14 |
| FLOW RIDER FLOW DIRECTED MICRO CATHETER (K980104) | Micro Therapeutics, Inc. | 1998-04-10 |
| CV PERI-GUARD - CARDIOVASCULAR PATCH (K971726) | Bio-Vascular, Inc. | 1998-04-10 |
| TEMPORARY CARDIAC PACING WIRE (K980503) | ETHICON, Inc. | 1998-04-10 |
| BETTER-TUBING (K964205) | Circulatory Technology, Inc. | 1998-04-08 |
| ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000) (K963703) | International Biophysics Corp. | 1998-04-08 |
| MANAN (K974743) | Medical Device Technologies, Inc. | 1998-04-06 |
| MANAN POTTS-COURNAND NEEDLE (K974742) | Medical Device Technologies, Inc. | 1998-04-06 |
| MANAN GWI GUIDE WIRE INTRODUCER (K974745) | Medical Device Technologies, Inc. | 1998-04-06 |
| OZ POWER SYRINGE (K973334) | Cardiovascular Innovations | 1998-04-03 |
| BIOLOG 3000 ELECTROCARDIOGRAPH (K974351) | Micromedical, Inc. | 1998-04-01 |
| BIPORE BALLOON DILATATION CATHETER (K973563) | Bipore, Inc. | 1998-04-01 |
| CARDIO-PAGER SYSTEM (K973527) | Data Critical Corp. | 1998-03-31 |
| CHASE FEMORAL ACCESS CANNULATION SET (K972993) | Chase Medical, Inc. | 1998-03-31 |