| RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777, 6778, 6779, 6780, 6781, 6782, (K021455) | Guidant Corp. | 2002-08-02 |
| DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N (K022193) | Ge Medical Systems Information Technologies | 2002-08-01 |
| VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K012687) | Vanguard Medical Concepts, Inc. | 2002-08-01 |
| ENVOY (K022168) | Mennen Medical , Ltd. | 2002-08-01 |
| VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K012688) | Vanguard Medical Concepts, Inc. | 2002-07-31 |
| MODIFICATION TO CARDEON AEGIS CATHETER (K022174) | Cardeon Corp. | 2002-07-29 |
| ILT ADVANCING MECHANISM, MODEL A115AMI (K021638) | Intra Luminal Therapeutics, Inc. | 2002-07-26 |
| XTD THROMBECTOMY CATHETER, XX CM (K021641) | Xtrak Medical, Inc. | 2002-07-26 |
| ELPH INJECTION SYSTEM (K022116) | Mallinckrodt Inc., Liebel-Flarsheim Business | 2002-07-26 |
| HEARTLINE RECEIVING STATION (K022073) | Aerotel Medical Systems (1998) , Ltd. | 2002-07-24 |
| ABP FOR WINDOWS (K021517) | Rozinn Electronics, Inc. | 2002-07-24 |
| DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE (K021376) | Datex-Ohmeda | 2002-07-24 |
| INFINITY MICRO2+ (K012770) | Siemens Medical Solutions USA, Inc. | 2002-07-23 |
| MICROPAQ, MODELS 402, 404 (K021681) | Welch Allyn Protocol, Inc. | 2002-07-23 |
| DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE (K021279) | Datex-Ohmeda | 2002-07-19 |
| GALT MEDICAL GUIDEWIRE (K021990) | Galt Medical Corp. | 2002-07-18 |
| REPROCESSED FEMORAL COMPRESSION DEVICE (K012574) | Sterilmed, Inc. | 2002-07-18 |
| PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.04, MODEL #M1275B (K021778) | Philips Medical Systems | 2002-07-17 |
| HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS (K022152) | Cambridge Heart, Inc. | 2002-07-16 |
| CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 (K022149) | Cambridge Heart, Inc. | 2002-07-16 |
| ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711 (K021874) | Abbott Laboratories | 2002-07-12 |
| DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100 (K021959) | Dolphin Medical, Inc. | 2002-07-11 |
| ILT TORQUER, MODEL 114TR1 (K021243) | Intra Luminal Therapeutics, Inc. | 2002-07-11 |
| CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072 (K021899) | Concentric Medical, Inc. | 2002-07-10 |
| BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM (K021473) | Augustine Medical, Inc. | 2002-07-09 |
| VP-2000/1000 (K013434) | Colin Corp. | 2002-07-09 |
| EASI 12 LEAD ALGORITHM (K020456) | Philips Medical Systems | 2002-07-09 |
| INTROCAN SAFETY IV CATHETER (K021094) | B.Braun Medical, Inc. | 2002-07-03 |
| HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A (K021453) | Philips Medical Systems | 2002-07-03 |
| TRELLIS PLUS INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH 20CM (100CM CATHETER LENGTH 10CM INFUSION H (K021958) | Bacchus Vascular, Inc. | 2002-07-03 |
| CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L (K012600) | Clearmedical, Inc. | 2002-07-03 |
| CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25 (K012609) | Clearmedical, Inc. | 2002-07-03 |
| MAC-LAB/CARDIOLAB EP/COMBOLAB (K021366) | General Electric Medical Systems Information Techn | 2002-07-03 |
| CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20 (K012622) | Clearmedical, Inc. | 2002-07-03 |
| DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 400 (K014255) | Ge Medical Systems Information Technologies | 2002-07-02 |
| MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 (K013205) | Millar Instruments, Inc. | 2002-07-02 |
| SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM (K021830) | Cobe Cardiovascular, Inc. | 2002-07-02 |
| QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52 (K021097) | Spacelabs Medical, Inc. | 2002-06-28 |
| BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA (K020382) | Medicotest A/S | 2002-06-28 |
| BODY FORCE, MODEL BT 6000 (K020211) | Composites Solutions, Inc. | 2002-06-28 |
| MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTIONAL THERMAL PRINTER (K021305) | Microlife Corp. | 2002-06-28 |
| WELCH ALLYN ABPM 6100 (K021756) | Welch Allyn, Inc. | 2002-06-27 |
| H12+HOLTER RECORDER (K021373) | Mortara Instrument, Inc. | 2002-06-27 |
| JUMP START, MODEL 970300 (K021168) | Medical Research Laboratories, Inc. | 2002-06-26 |
| TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE (K014009) | Tanita Corp. of America | 2002-06-24 |
| M2376 DEVICELINK SYSTEM (K021912) | Philips Medical Systems, Inc. | 2002-06-24 |
| CARDEON AEGIS CATHETER (K013593) | Cardeon Corp. | 2002-06-24 |
| EQUALIZER BALLOON CATHETER (K021721) | Boston Scientific Corp | 2002-06-20 |
| SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA (K013896) | Defibtech, LLC | 2002-06-19 |
| OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR (K021089) | Nellcor Puritan Bennett, Inc. | 2002-06-19 |
| MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM (K021066) | Micro Therapeutics, Inc. | 2002-06-18 |
| BLOOD-PRESSURE METER (K021252) | Idt Technology Limited | 2002-06-17 |
| AIRCAST, MODEL #3011 (K013297) | Millenium Reprocessing Services, Inc. | 2002-06-14 |
| RADIUS SNARE (K021441) | Radius Medical Technologies, Inc. | 2002-06-14 |
| OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE (K020896) | Osypka Medical, Inc. | 2002-06-14 |
| EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER (K020857) | Vasomedical, Inc. | 2002-06-14 |
| SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS (K013022) | Sulzer Carbomedics, Inc. | 2002-06-13 |
| MODIFICATION TO ENVOY AND VISTA BRITE TIP (K021593) | Cordis Corp. | 2002-06-13 |
| BD INTROSYTE PRECISION INTRODUCER; BD INTROSYTE-N PRECISION INTRODUCER; BD INTROSYTE AUTOGUARD SHIELDED INTRODUCER; BD I (K020834) | Becton Dickinson Infusion Therapy Systems, Inc. | 2002-06-12 |
| SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM (K012512) | Radiant Medical | 2002-06-11 |
| ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840 (K021462) | Arrow Intl., Inc. | 2002-06-06 |
| VALVED PEELABLE INTRODUCER (K021004) | Medamicus, Inc. | 2002-06-06 |
| PHYSIOLOG, SERIES 95000 (K013032) | Camtronics, Ltd. | 2002-06-04 |
| BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR (K020739) | Bci, Inc. | 2002-06-03 |
| CHARE CARIOVASCULAR PATCH (K021129) | Chase Medical, Inc. | 2002-06-03 |
| SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117 (K020821) | Biotronik, Inc. | 2002-06-03 |
| EN-SNARE ENDOVASCULAR SNARE AND CATHETER (K021606) | Medical Device Technologies, Inc. | 2002-05-31 |
| ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A (K021587) | Medtronic Vascular | 2002-05-30 |
| ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218 (K021589) | Medtronic Vascular | 2002-05-30 |
| MICRO-INDUCTION 1000 SYSTEM (K013615) | Harbinger Medical, Inc. | 2002-05-29 |
| ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR (K011461) | Access Cardiosystems, Inc. | 2002-05-28 |
| PADPRO, MODEL 2502 (K020743) | Padpro, LLC | 2002-05-28 |
| SYNCRUS INTERNAL CARDIOVERSION SYSTEM (K020701) | Guidant Corporation, Cardiac Surgery | 2002-05-24 |
| UNITY IS PATIENT VIEWER (K020661) | General Electric Medical Systems Information Techn | 2002-05-24 |
| PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046 (K020587) | Pulsion Medical Systems AG | 2002-05-23 |
| N2000 BASE STATION; N2001 NURSE STATION (K020584) | Neptec Design Group, Ltd. | 2002-05-22 |
| TELE-CLINIQ DATA TRANSMISSION SYSTEM BLOOD PRESSURE MEASUREMENT SYSTEM (K021447) | Aerotel Medical Systems (1998) , Ltd. | 2002-05-22 |
| PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS (K021591) | Cordis Neurovascular, Inc. | 2002-05-22 |
| MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM (K021323) | Intra Luminal Therapeutics, Inc. | 2002-05-22 |
| ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I (K021225) | Rossmax International , Ltd. | 2002-05-22 |
| DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N (K021435) | Ge Medical Systems Information Technologies | 2002-05-22 |
| MEDAMICUS AXIA RSN (K020563) | Medamicus, Inc. | 2002-05-21 |
| Z3 GUIDE CATHETER (K021256) | Medtronic Vascular | 2002-05-17 |
| SMARTWIRE/SMARTMAP PRESSURE SYSTEM (K021219) | Jomed, Inc. | 2002-05-17 |
| CONSTELLATION CATHETERS, MODEL 8031M (K021232) | Boston Scientific Corp | 2002-05-16 |
| PHILIPS INFORMATION CENTER SOFTWARE REVISION D.02 (K021422) | Philips Medical Systems | 2002-05-15 |
| HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE (K021228) | Guidant Corp. | 2002-05-15 |
| REPROCESSED COMPRESSION LIMB SLEEVES (K012658) | Surgical Instruments Service and Savings, Inc. | 2002-05-14 |
| SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3 (K021246) | Sensidyne, Inc. | 2002-05-13 |
| MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER (K020634) | Atrium Medical Corp. | 2002-05-08 |
| MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B (K021300) | Philips Medical Systems | 2002-05-08 |
| COMPRESSIBLE LIMB SLEEVE (K012979) | Medical Device Services, Inc. | 2002-05-08 |
| QFLOW 500 PERFUSION MONITORING SYSTEM (K013376) | Hemedex Incorporated | 2002-05-08 |
| PADPRO MODEL #2516 (K020203) | Padpro, LLC | 2002-05-08 |
| NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 (K012712) | Norav Medical , Ltd. | 2002-05-08 |
| Q-STRESS ECHO BED (K021171) | Medical Positioning, Inc. | 2002-05-08 |
| OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER (K021090) | Nellcor Puritan Bennett, Inc. | 2002-05-08 |
| MODIFICATION OF APEXPRO TELEMETRY SYSTEM (K021325) | General Electric Medical Systems Information Techn | 2002-05-07 |
| ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I. (K021251) | Philips Medical Systems | 2002-05-07 |
| TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT (K021287) | Medtronic Perfusion Systems | 2002-05-07 |