| HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A (K001725) | Agilent Technologies, Inc. | 2000-09-08 |
| SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER (K001995) | Qrs Diagnostic, LLC | 2000-09-08 |
| CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE (K000830) | California Medical Laboratories, Inc. | 2000-09-07 |
| MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDT (K002574) | Masimo Corp. | 2000-09-06 |
| CAPIOX ARTERIAL FILTER (K002026) | Terumo Medical Corp. | 2000-09-06 |
| AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK (K001149) | Augustine Medical, Inc. | 2000-09-06 |
| S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE (K002158) | Datex-Ohmeda, Inc. | 2000-09-06 |
| BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020 (K000743) | Boston Scientific Scimed, Inc. | 2000-09-06 |
| DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-550 (K002655) | Meditec Co., Ltd. | 2000-09-06 |
| LIFE SCOPE EC, MODEL BSM-1102 (K000517) | Nihon Kohden America, Inc. | 2000-08-31 |
| ROTAFLOW CENTRIFUGAL PUMP SYSTEM (K991864) | Jostra Medizintechnik AG | 2000-08-31 |
| GAZELLE BALLOON DILATATION CATHETER (K001134) | Boston Scientific Corp | 2000-08-31 |
| VASOTRAX (K001898) | Medwave, Inc. | 2000-08-31 |
| BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220 (K002333) | Biosense Webster, Inc. | 2000-08-31 |
| MINOLTA PULSOX-3/MINOLTA PULSOX-3I (K984570) | In-X Corp. | 2000-08-30 |
| EHC500 DESKTOP PATIENT STATION, MODEL EHC500 (K002388) | Cybercare, Inc. | 2000-08-25 |
| DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET (K002365) | Datascope Corp. | 2000-08-25 |
| WIZAIR COMPRESSION SYSTEM (K002287) | Medical Compression Systems (Dbn) , Ltd. | 2000-08-25 |
| HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO (K002206) | Guidant Corp. | 2000-08-24 |
| EPIC SPO2 FINGER SENSOR, MODEL E412-20 (K002223) | Epic Medical Equipment Services, Inc. | 2000-08-22 |
| CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING (K002238) | Terumo Cardiovascular Systems Corp. | 2000-08-22 |
| GE MARQUETTE ECG ANALYSIS PROGRAM (K002209) | General Electric Medical Systems Information Techn | 2000-08-18 |
| CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002 (K002230) | Cambridge Heart, Inc. | 2000-08-18 |
| SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX (K993698) | Mogul Enterprises | 2000-08-16 |
| GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300 (K001969) | Medtronic Vascular | 2000-08-16 |
| V QUICK PATCH (K993934) | Vq Corp. | 2000-08-15 |
| BMT ANSCORE HEALTH MANAGEMENT SYSTEM (K993875) | Boston Medical Technologies, Inc. | 2000-08-11 |
| STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB (K001565) | Edwards Lifesciences, LLC | 2000-08-10 |
| CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01 (K001091) | Next Millennium Software Solutions, Inc. | 2000-08-10 |
| TRUE (K993913) | Infinity Extrusion & Engineering, Inc. | 2000-08-09 |
| S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0 (K002116) | Medical Device Consultants, Inc. | 2000-08-09 |
| QUINTON Q-STRESS, MODEL 000483 (K001492) | Quinton, Inc. | 2000-08-09 |
| STOCKERT COMPACT SYSTEM VERSION 2.0 (K002118) | Stoeckert Instrumente | 2000-08-09 |
| R.TEST EVOLUTION (K993788) | Novacor Div. | 2000-08-04 |
| EXCELSIOR 1018 MICROCATHETER (K994155) | Boston Scientific, Target | 2000-08-03 |
| MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608 (K002212) | Micro Therapeutics, Inc. | 2000-08-03 |
| GALEO HYDRO AND GALEO HYDRO J-TIP (K001736) | Biotronik, Inc. | 2000-08-02 |
| HP M2376A DEVICE LINK SYSTEM, MODEL M2376A (K002009) | Agilent Technologies, Inc. | 2000-08-02 |
| CHASE CARDIOVASCULAR PATCH (K001662) | Chase Medical, Inc. | 2000-08-02 |
| MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1 (K001182) | Microlife Corp. | 2000-08-01 |
| COAXIAL DILATOR SET (K000737) | Xentek Medical, Inc. | 2000-08-01 |
| DATA MASTER PERFUSION MONITORING SYSTEM (K001388) | Dideco | 2000-07-28 |
| CARDIOVISE ECG INTERPRETATIVE SOFTWARE (K001349) | Inovise Medical, Inc. | 2000-07-27 |
| RESPIEVENTS, VERSION 4.2 (K001369) | Non-Invasive Monitoring Systems, Inc. | 2000-07-26 |
| A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS (K002115) | A&D Engineering, Inc. | 2000-07-25 |
| CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW1000 (K994141) | Medtronic Ave, Inc. | 2000-07-21 |
| ARIA (K001317) | Del Mar Medical Systems, LLC | 2000-07-21 |
| BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES (K001390) | Biosense Webster, Inc. | 2000-07-21 |
| MODIFICATION TO AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 (K002046) | Vsm Technology, Inc. | 2000-07-21 |
| MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500 (K001930) | Nonin Medical, Inc. | 2000-07-20 |
| DR180-II (K001288) | North East Monitoring, Inc. | 2000-07-20 |
| STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX (K001306) | Andromed, Inc. | 2000-07-20 |
| BOOKER BOX, MODEL PAD 5010 (K993205) | Tz Medical, Inc. | 2000-07-20 |
| REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND (K001966) | Micro Therapeutics, Inc. | 2000-07-20 |
| PTA BALLOON CATHETER (K001087) | Cook, Inc. | 2000-07-20 |
| DASH 3000/4000 PATIENT MONITOR (K001359) | General Electric Medical Systems Information Techn | 2000-07-18 |
| GE MARQUETTE PRISM INFORMATION SERVER APPLICATIONS (K001268) | General Electric Medical Systems Information Techn | 2000-07-17 |
| WELCH ALLYN INSTRUMENT INTERFACE MODULE (K001265) | Welch Allyn, Inc. | 2000-07-13 |
| DATEX-OHMEDA NETWORK AND CENTRAL (K000647) | Datex-Ohmeda, Inc. | 2000-07-13 |
| AMPLATZER SIZING BALLOON (K993248) | Aga Medical Corp. | 2000-07-12 |
| NUMED Z-5 ATRIOSEPTOSTOMY CATHETER (K001804) | NuMED, Inc. | 2000-07-12 |
| SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7 (K001063) | Baxter Healthcare Corp | 2000-07-07 |
| SNIPER, MODEL OR-3872XX SERIES (K001251) | Nipro Medical Corp. | 2000-07-07 |
| THE V-BAG (K001822) | Circulatory Technology, Inc. | 2000-07-07 |
| CARDEON ASCENDING BALLOON CANNULA (ABC) (K001371) | Cardeon Corp. | 2000-07-07 |
| CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT (K000062) | Cordis Corp. | 2000-07-07 |
| FLUORO-TEX CARDIOVASCULAR PATCH (K994032) | Bridger Biomed, Inc. | 2000-07-07 |
| BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A (K001770) | Bci, Inc. | 2000-07-05 |
| OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907 (K001848) | Omron Healthcare, Inc. | 2000-07-03 |
| 6F & 7F INTRODUCING CATHETERS (MODIFICATION) (K001135) | Cordis Corp. | 2000-07-03 |
| COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT M3000A/M3046A OPTION J120 (K001664) | Agilent Technologies, Inc. | 2000-06-30 |
| ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630 (K001671) | Omron Healthcare, Inc. | 2000-06-30 |
| AGILENT COMPONENT MONITORING SYSTEM; AGILENT INVASIVE BLOOD PRESSURE MODULE (K001722) | Agilent Technologies Deutschland GmbH | 2000-06-30 |
| AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-757 (K001670) | Omron Healthcare, Inc. | 2000-06-30 |
| BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810 (K001081) | Cardiodynamics International Corp. | 2000-06-30 |
| MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A (K001776) | Agilent Technologies, Inc. | 2000-06-30 |
| DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER (K001688) | Datex-Ohmeda, Inc. | 2000-06-30 |
| QUART ARTERIAL FILTER, MODEL HBF 140 (K001787) | Jostra Medizintechnik AG | 2000-06-30 |
| MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM (K001305) | General Electric Medical Systems Information Techn | 2000-06-27 |
| TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528 (K001180) | Pace Medical | 2000-06-27 |
| GEMINI E (K993623) | Allen Medical Instruments Corp. | 2000-06-23 |
| VASO PRESS DVT SYSTEM, MODELS VP500, VP501 (K991038) | Britt Corp., Inc. | 2000-06-22 |
| PLACER MODEL 6232 STEERABLE STYLET (K000955) | Medtronic Vascular | 2000-06-16 |
| ECHOCOM, IMAGECOM, DOKUCOM (K001592) | Tomtec Imaging Systems GmbH | 2000-06-16 |
| TEARAWAY INTRODUCER SHEATH (K000313) | Xentek Medical, Inc. | 2000-06-16 |
| GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC (K001112) | General Electric Medical Systems Information Techn | 2000-06-14 |
| STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP (K994209) | Cobe Cardiovascular, Inc. | 2000-06-14 |
| PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM (K001762) | Pulsion Medical Systems, Inc. | 2000-06-13 |
| EHC 400 DESKTOP PATIENT STATION, EHC 600 CORE PROVIDER STATION (K000237) | Cybercare, Inc. | 2000-06-13 |
| MODEL APS ALTERNANS PROCESSING SYSTEM (K001034) | Cambridge Heart, Inc. | 2000-06-09 |
| UEDA UDEX SUPER BP-2000 AUTOMATIC BLOOD PRESSURE RECORDING DEVICE (K993316) | Ueda Avancer Corp. | 2000-06-09 |
| ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER (K991137) | Minntech Corp. | 2000-06-08 |
| DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.) (K001602) | Dideco S.P.A. | 2000-06-08 |
| ENGAGE JAW INSERTS (K992980) | Novare Surgical Systems, Inc. | 2000-06-08 |
| TALON BALLOON DILATION CATHETER (K000798) | Boston Scientific Corp | 2000-06-08 |
| AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A) (K000815) | Datex-Ohmeda | 2000-06-08 |
| ALLON 2001 (K001546) | Mtre Advanced Technology , Ltd. | 2000-06-08 |
| ENSITE 3000 SYSTEM, MODEL EE3000 (K001437) | Endocardial Solutions, Inc. | 2000-06-07 |
| SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D (K001454) | Micro Therapeutics, Inc. | 2000-06-07 |
| CIPA (ADULTS) CIPI (INFANTS) (K992932) | Dmc Medical, Ltd. | 2000-06-07 |