| BCI ADVISOR VITAL SIGNS MONITOR (9200) (K010770) | Bci, Inc. | 2001-06-12 |
| HEARTCARD, MODEL 5258 (K010945) | Instromedix | 2001-06-12 |
| H-SCRIBE (K004017) | Mortara Instrument, Inc. | 2001-06-11 |
| BPFONE, MODEL UA 767IT (K010751) | Medical Monitors Pty Limited | 2001-06-11 |
| HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B (K010634) | Agilent Technologies, Inc. | 2001-06-11 |
| REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000) (K010791) | Adsis , Ltd. | 2001-06-08 |
| MEDLEY SP02 MODULE, MODEL 8220 (K010966) | Alaris Medical Systems, Inc. | 2001-06-08 |
| M2376A DEVICELINK SYSTEM, MODEL M2376A (K011578) | Agilent Technologies, Inc. | 2001-06-08 |
| ORIGEN DUAL LUMEN CATHETER (K003288) | Origen Biomedical, Inc. | 2001-06-08 |
| WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM (K010186) | Welch Allyn, Inc. | 2001-06-08 |
| CPR EZY MASK AND PAD (K003937) | Medteq Innovations Pty, Ltd. | 2001-06-06 |
| AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 (K010471) | Irvine Biomedical, Inc. | 2001-06-06 |
| BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755 (K003570) | Bacchus Vascular, Inc. | 2001-06-06 |
| PARODI CATHETER FOR ANGIOGRAPHY (PARCA) (K001917) | Arteria Medical Science, Inc. | 2001-06-06 |
| TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A (K010083) | Cordis Corp. | 2001-06-06 |
| SPARROWHAWK DISPOSABLE (K010473) | Atc Technologies, Inc. | 2001-06-06 |
| PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM (K003992) | Percu Surge, Inc. | 2001-06-01 |
| INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX (K002847) | Maxxim Medical | 2001-05-31 |
| CADHEALTH SYSTEM, MODEL CHP-001 (K002514) | Caduceus Health Care , Ltd. | 2001-05-31 |
| VASOTRAC APM205A (K011152) | Medwave, Inc. | 2001-05-31 |
| RADIUS COUGAR WIRE (K011287) | Radius Medical Technologies, Inc. | 2001-05-25 |
| SPO2 WRAP SENSOR (K002848) | Epic Medical Equipment Services, Inc. | 2001-05-24 |
| CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM (K011324) | Cambridge Heart, Inc. | 2001-05-23 |
| BIOCONNECT PATIENT MONITORING CABLES AND LEADWIRES, CAT# 1000 THRU CAT# 40000 (K010809) | Rf Industries, Ltd. | 2001-05-23 |
| BCI ADVISOR VITAL SIGNS MONITOR (9200) (K011177) | Bci, Inc. | 2001-05-23 |
| BIOSPHERE MEDICAL INFUSION CATHETER (K003105) | Biosphere Medical | 2001-05-22 |
| PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS (K010787) | Oscor, Inc. | 2001-05-22 |
| CONCENTRIC RETRIEVER, MODEL 90030 (K003410) | Concentric Medical, Inc. | 2001-05-22 |
| OSCOR PERMANENT PACING LEAD RZ MODEL SERIES (K003918) | Oscor, Inc. | 2001-05-22 |
| EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026 (K010162) | Micro Therapeutics, Inc. | 2001-05-18 |
| ADVANTA SST GRAFT (<6MM) (K010517) | Atrium Medical Corp. | 2001-05-18 |
| ADVANTA SST GRAFT (>_6MM) (K010516) | Atrium Medical Corp. | 2001-05-18 |
| VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER (K010485) | Bbraun | 2001-05-18 |
| VASO PRESS DVT FOOT GARMENT #VP 520 (K003828) | Britt Corp., Inc. | 2001-05-18 |
| CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012 (K003084) | Concentric Medical, Inc. | 2001-05-16 |
| ACTIVEECG (K010587) | Active Corp. | 2001-05-16 |
| CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A (K003707) | Cardionet | 2001-05-16 |
| CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT (K011217) | Abbott Laboratories | 2001-05-16 |
| CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008 (K003086) | Concentric Medical, Inc. | 2001-05-16 |
| BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES (K003732) | Braun GmbH | 2001-05-16 |
| CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F) (K003880) | Concentric Medical, Inc. | 2001-05-16 |
| GUIDANT RETRIEVER DEVICE (K001694) | Guidant Cardiac and Vascular Surgery | 2001-05-15 |
| TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011 (K010436) | Remote Diagnostic Technologies , Ltd. | 2001-05-14 |
| IMPRA CARBOFLO EPTFE VASCULAR GRAFTS (K004012) | Impra, Inc. | 2001-05-14 |
| SMARTFLOW, MODEL SFIP 2000 (K003122) | Florence Medical , Ltd. | 2001-05-14 |
| CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER (K003020) | Cd Leycom BV | 2001-05-11 |
| MANDREL GUIDEWIRE ASSEMBLY (K011084) | Lake Region Mfg., Inc. | 2001-05-10 |
| BRIDGE III RECEIVER (K010794) | Meridian Medical Technologies , Ltd. | 2001-05-10 |
| ENVOY PATIENT MONITOR (K001120) | Mennen Medical , Ltd. | 2001-05-08 |
| REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR (K011098) | Medtronic Vascular | 2001-05-04 |
| ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP (K002256) | Arrow Intl., Inc. | 2001-05-03 |
| PTA-OS SIZING BALLOON, MODEL 360 (K003320) | NuMED, Inc. | 2001-05-02 |
| SIII ALARM AMPLIFIER (K011088) | Stockert Instrumente GmbH | 2001-05-02 |
| HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A (K003819) | Agilent Technologies, Inc. | 2001-05-02 |
| SYNETEC (K002817) | Ela Medical, Inc. | 2001-05-02 |
| VASCULAR ASSIST (K002186) | Huntleigh Healthcare, Inc. | 2001-05-02 |
| SPHYGMOCOR MX MODEL SCOR-MX (K002742) | Pwv Medical Pty, Lt. | 2001-05-01 |
| AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154 (K011093) | Agilent Technologies, Inc. | 2001-05-01 |
| GRAFT MARKER RING (K001915) | T. Korossurgical Instruments Corp. | 2001-04-27 |
| ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER (K002627) | Atrium Medical Corp. | 2001-04-26 |
| COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR (K004046) | Cobe Cardiovascular, Inc. | 2001-04-26 |
| BMT ANSCORE HEALTH MANAGEMENT SYSTEM (K010955) | Boston Medical Technologies, Inc. | 2001-04-26 |
| EMBOL-X INTRODUCER, MODEL CF00200 (K002973) | Embol-X, Inc. | 2001-04-26 |
| NOVAMETRIX MARQUETTE COMPATIBLE SENSORS (K010451) | Novametrix Medical Systems, Inc. | 2001-04-25 |
| ORIGEN BLADDER HOLDER (K003145) | Origen Biomedical, Inc. | 2001-04-20 |
| NUMED HIGH PRESSURE PTA CATHETERS (K010880) | NuMED, Inc. | 2001-04-20 |
| AB CARDIETTE START 200 HV (K010822) | H&C Medical Devices Spa | 2001-04-18 |
| GUIDER SOFTIP GUIDING CATHETER XF 5F (K010853) | Boston Scientific, Target | 2001-04-18 |
| ILT DEFLECTING CATHETER, MODEL C114ND1 (K010531) | Intra Luminal Therapeutics, Inc. | 2001-04-18 |
| OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD (K002036) | Osi Medical, Inc. | 2001-04-17 |
| CH 2000 CARDIAC DIAGNOSTIC SYSTEM (K010756) | Cambridge Heart, Inc. | 2001-04-12 |
| HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS (K010758) | Cambridge Heart, Inc. | 2001-04-12 |
| SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE (K003731) | Thomas Medical Products, Inc. | 2001-04-10 |
| ICG MODULE (K010164) | General Electric Medical Systems Information Techn | 2001-04-09 |
| PREAMP CABLE, MODEL B400-1011PA (K003542) | Beta Biomed Services, Inc. | 2001-04-06 |
| MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254 (K010906) | Medtronic Vascular | 2001-04-05 |
| SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800) (K003701) | Sentech Medical Systems, Inc. | 2001-04-05 |
| ALARMVIEW WIRELESS DATA NETWORK SYSTEM (K010912) | Data Critical Corp. | 2001-04-05 |
| SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924 (K010737) | Medtronic Cardiac Surgical Products | 2001-04-04 |
| GUIDANT AXIUS CORONARY SHUNT (K010117) | Cardiothoracic Systems, Inc. | 2001-04-04 |
| RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET (K002019) | Sorin Group Italia S.R.L. | 2001-03-30 |
| PRESSURE TRAK, MODEL 222-B (K010622) | Suntech Medical Instruments, Inc. | 2001-03-29 |
| FINGER PULSE METER (K000814) | Bhs Intl., Inc. | 2001-03-29 |
| DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP (K010828) | A&D Engineering, Inc. | 2001-03-29 |
| ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975 (K010707) | Boston Scientific, Target | 2001-03-29 |
| LOCALISA CARDIAC NAVIGATION SYSTEM (K002869) | Medtronic Surgical Navigation Technologies | 2001-03-27 |
| 3M LITTMANN (K003723) | 3M Company | 2001-03-27 |
| IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS (K004011) | Impra, Inc. | 2001-03-27 |
| FOGARTY VALVULOTOME, MODEL 700091 (K001734) | Edwards Lifesciences, LLC | 2001-03-26 |
| COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS (K000977) | Olson Medical Sales, Inc. | 2001-03-23 |
| FLEXI-SITE SP02 EAR SENSOR (K010718) | Epic Medical Equipment Services, Inc. | 2001-03-23 |
| LDOB OCCLUSION BALLOON CATHETER (K002286) | Cook, Inc. | 2001-03-22 |
| SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300 (K010497) | Micro Therapeutics, Inc. | 2001-03-22 |
| TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT (K002507) | Arrow Intl., Inc. | 2001-03-21 |
| KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C (K010686) | Golden Horse Medical Equipment (Wuxi) Co. , Ltd. | 2001-03-21 |
| PLEURX PLEURAL CATHETER AND DRAINAGE KITS (K010642) | Denver Biomedicals, Inc. | 2001-03-20 |
| ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1 (K010482) | Echocath, Inc. | 2001-03-20 |
| WRISTWATCH BLOOD PRESSURE MONITOR A46 (K010498) | Rossmax Internationl , Ltd. | 2001-03-20 |
| SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER (K010640) | Siemens Medical Solutions USA, Inc. | 2001-03-20 |
| WRISTWATCH BPM BLOOD PRESSURE MONITOR, MODEL KP-6120 (K002665) | K-Jump Health Co., Ltd. | 2001-03-19 |