| AGILENT M2636A TELEMON MONITOR (K001436) | Agilent Technologies, Inc. | 2000-06-07 |
| STAT-SHELL DISPOSABLE SP02 SENSOR (K000831) | Epic Medical Equipment Services, Inc. | 2000-06-05 |
| AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700 (K000820) | Endosonics Corp. | 2000-06-05 |
| X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR (K993772) | Terumo Medical Corp. | 2000-06-05 |
| DATEX-OHMEDA CS/3 TELEMETRY SYSTEM (K000882) | Datex-Ohmeda | 2000-06-05 |
| VIKING OPTIMA GUIDING CATHETER (K001435) | Guidant Corp. | 2000-06-02 |
| ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668 (K001413) | Biotronik, Inc. | 2000-06-02 |
| MODIFICATION TO ACIST CL 100H (K991103) | Acist Medical Systems | 2000-05-31 |
| ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B (K984231) | Invasatec | 2000-05-31 |
| FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX (K001367) | St. Jude Medical, Inc. | 2000-05-31 |
| INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS) (K992668) | Innerdyne, Inc. | 2000-05-26 |
| DINAMAP ADVANCED NIBP MODULE (K000500) | Critikon Company, LLC | 2000-05-26 |
| GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11 (K000645) | General Electric Medical Systems Information Techn | 2000-05-24 |
| ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX (K001346) | St. Jude Medical, Inc. | 2000-05-24 |
| CARDTEL, MODEL NT-100 (K000609) | Cardiac Telecommunications | 2000-05-23 |
| ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL (K000729) | Arrow Intl., Inc. | 2000-05-19 |
| PROAIR 3000 COMPRESSION SYSTEM (K993758) | Medical Compression Systems (Dbn) , Ltd. | 2000-05-19 |
| HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE (K992543) | Hewlett-Packard Co. | 2000-05-18 |
| APEXPRO TELEMETRY SYSTEM (K000779) | General Electric Medical Systems Information Techn | 2000-05-18 |
| EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO (K001237) | Micro Therapeutics, Inc. | 2000-05-18 |
| MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER (K992320) | Boston Scientific Corp | 2000-05-18 |
| MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW (K001308) | Agilent Technologies | 2000-05-17 |
| AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR, AGILENT NONI (K001333) | Agilent Technologies Deutschland GmbH | 2000-05-17 |
| ST/AR ST AND ARRHYTHMIA SOFTWARE (K001348) | Agilent Technologies, Inc. | 2000-05-17 |
| HEART 2005 (K000775) | Aerotel Medical Systems (1998) , Ltd. | 2000-05-17 |
| MODIFICATION TO ENVOY PATIENT MONITOR (K000563) | Mennen Medical , Ltd. | 2000-05-17 |
| 3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE (K000690) | Minnesota Mining and Mfg. Co. | 2000-05-17 |
| HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS FOR THE LIMB (K000303) | Healthcare Service and Supply | 2000-05-16 |
| ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX (K994334) | Daig Corp. | 2000-05-15 |
| DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET (K001198) | Datascope Corp. | 2000-05-12 |
| PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR (K991886) | Pulsion Medical Systems, Inc. | 2000-05-11 |
| PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M (K001139) | Biosense Webster, Inc. | 2000-05-10 |
| DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP (K994243) | Heartport, Inc. | 2000-05-05 |
| CARTO EP NAVIGATION SYSTEM (K000248) | Biosense Webster, Inc. | 2000-05-05 |
| EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR (K991293) | Fischer Medical Technologies, Inc. | 2000-05-05 |
| BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH (K001100) | Cardiodynamics International Corp. | 2000-05-05 |
| MODIFICATION TO CARTO EP NAVIGATION SYSTEM (K000190) | Biosense Webster, Inc. | 2000-05-05 |
| NOGA CARDIAC NAVIGATION SYSTEM (K000332) | Biosense Webster, Inc. | 2000-05-04 |
| A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000 (K992592) | A-Med Systems, Inc. | 2000-05-04 |
| BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD (K993816) | Baxter Edwards | 2000-05-04 |
| AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT M2/M3/M4 COMPACT PORTABLE PATIENT MONITOR (K001057) | Agilent Technologies, Inc. | 2000-05-03 |
| TEMPO AQUA ANGIOGRAPHIC CATHETER (K000579) | Cordis Corp. | 2000-05-03 |
| MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500 (K001085) | Nonin Medical, Inc. | 2000-05-01 |
| CORDIS INTRODUCER GUIDE (K001136) | Cordis Corp. | 2000-04-28 |
| POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002 (K993564) | Possis Medical, Inc. | 2000-04-28 |
| MODEL 120 (K994372) | Palco Labs, Inc. | 2000-04-28 |
| 8100 VITAL SIGNS MONITOR (K001020) | Criticare Systems, Inc. | 2000-04-28 |
| AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354 (K001138) | Medtronic Vascular | 2000-04-27 |
| MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE (K994171) | Medtronic Cardiac Surgical Products | 2000-04-27 |
| LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902 (K001021) | Dideco S.P.A. | 2000-04-25 |
| COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR (K000255) | Cobe Cardiovascular, Inc. | 2000-04-25 |
| MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS (K000956) | Boston Scientific Scimed, Inc. | 2000-04-21 |
| LIFECARD CF COMPACT RECORDER (K001025) | Reynolds Medical , Ltd. | 2000-04-19 |
| MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT (K993677) | Medtronic Vascular | 2000-04-17 |
| AGILITY STEERABLE GUIDEWIRE (K001033) | Cordis Neurovascular, Inc. | 2000-04-14 |
| MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA (K000126) | Masimo Corp. | 2000-04-14 |
| FIXATION STYLETS, MODELS 335-287 AND 335-288 (K000366) | Accufix Research Institute | 2000-04-14 |
| BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA (K000570) | Boston Scientific Corp | 2000-04-13 |
| PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 (K000206) | Axelgaard Mfg. Co., Ltd. | 2000-04-13 |
| EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133 (K994240) | Biotronik, Inc. | 2000-04-13 |
| CTC DVT-1 CALF GARMENT, MODEL DVT-1 (K000147) | Compression Therapy Concepts, Inc. | 2000-04-13 |
| PERCUTANEOUS INTRODUCER, MODEL 10383-XXX (K000824) | Medamicus, Inc. | 2000-04-13 |
| LEMAITRE OCCLUSION CATHETER (K992942) | Vascutech, Inc. | 2000-04-13 |
| CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A) (K000168) | Datex-Ohmeda | 2000-04-13 |
| TFX MEDICAL STYLET CATHETER (K992664) | Tfx Medical Group | 2000-04-13 |
| DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR) (K993608) | Datex-Ohmeda, Inc. | 2000-04-13 |
| SOFTLINE SPRING CLIP (K000098) | Novare Surgical Systems, Inc. | 2000-04-12 |
| POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140 CATHETER MODEL 3040C (K972610) | Possis Medical, Inc. | 2000-04-11 |
| TRANSLUMINAL BALLOON DILATATION CATHETER (K993305) | Boston Scientific Corp | 2000-04-10 |
| VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY SYSTEM TRANSMITTER (K000854) | Agilent Technologies, Inc. | 2000-04-10 |
| MECA WRIST BLOOD PRESSURE METER, MODEL EW243 AND MODEL EW254 (K991458) | Matsushita Electric Corp. of America | 2000-04-10 |
| STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS (K993448) | Ela Medical, Inc. | 2000-04-10 |
| MODIFICATION TO MARSPO2, MODEL 2001 (K000794) | Novametrix Medical Systems, Inc. | 2000-04-10 |
| PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2 (K993414) | Prucka Engineering, Inc. | 2000-04-07 |
| RENEGADE HI-FLO MICROCATHETER (K000177) | Boston Scientific Corp | 2000-04-07 |
| FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX (K000746) | Fukuda Denshi USA, Inc. | 2000-04-07 |
| PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051 (K000763) | Biotronik, GmbH & Co. | 2000-04-06 |
| ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000 (K991060) | Zcv ,Inc. | 2000-04-06 |
| CORDIS 13F CATHETER SHEATH INTRODUCER (K000753) | Cordis Corp. | 2000-04-06 |
| AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR (K000822) | Agilent Technologies, GmbH | 2000-04-06 |
| STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS (K000029) | Ela Medical, Inc. | 2000-04-04 |
| DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER (K993512) | Datex-Ohmeda, Inc. | 2000-03-31 |
| ENVOY AND VISTA BRITE TIP (K000715) | Cordis Corp. | 2000-03-31 |
| MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED (K992215) | Envitec-Wismar GmbH | 2000-03-29 |
| MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT (K000659) | Merit Medical Systems, Inc. | 2000-03-29 |
| ZUMA GUIDE CATHETERS (K000677) | Medtronic Vascular | 2000-03-29 |
| AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 (K994423) | Vsm Medtech , Ltd. | 2000-03-28 |
| WESCO BLANKET (K981093) | Wesco, Inc. | 2000-03-28 |
| IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM (K994430) | General Electric Medical Systems Information Techn | 2000-03-28 |
| GAS FILTER (K993060) | Olson Medical Sales, Inc. | 2000-03-28 |
| ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000 (K000013) | Acist Medical Systems | 2000-03-28 |
| ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413 (K000660) | Medical Data Electronics | 2000-03-28 |
| COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED (K994389) | Cobe Cardiovascular, Inc. | 2000-03-27 |
| 5F GUIDING CATHETER (K000598) | Guidant Corp. | 2000-03-24 |
| TFX MEDICAL INTRODUCER ASSEMBLY (K993191) | Tfx Medical, Inc. | 2000-03-24 |
| BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER (K993292) | Boston Scientific, Target | 2000-03-23 |
| 3S INJECTOR-CT CONTRAST DELIVERY SYSTEM (K983826) | Unimachs Corp. | 2000-03-23 |
| PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP (K992174) | Pilling Weck Surgical | 2000-03-23 |
| EP MEDSYSTEMS, EP-WORKMATE (K994011) | Ep Medsystems, Inc. | 2000-03-23 |
| NARKOMED 6000 (K993826) | Draeger Medical, Inc. | 2000-03-23 |