| BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T (K010452) | Koven Technology, Inc. | 2002-02-12 |
| ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0 (K014261) | Philips Medical Systems, Inc. | 2002-02-12 |
| REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS (K012675) | Adven Medical | 2002-02-12 |
| COBE REVOLUTION (K011835) | Cobe Cardiovascular, Inc. | 2002-02-12 |
| SENSAID (K011974) | Sensidyne, Inc. | 2002-02-12 |
| LUMEND FRONTRUNNER CTO CORONARY CATHETER (K013284) | Lumend, Inc. | 2002-02-11 |
| TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH); TRELLIS INFUSION SYSTEM (20CM INFUSION LENGTH) (K013635) | Bacchus Vascular, Inc. | 2002-02-11 |
| INCLUDER CLAMP (K010694) | Novare Surgical Systems, Inc. | 2002-02-11 |
| SOLAR 8000M SYSTEM (K012467) | General Electric Medical Systems Information Techn | 2002-02-11 |
| BACK-UP MEIER STEERABLE GUIDEWIRE (K020283) | Boston Scientific Corp | 2002-02-11 |
| STERILMED REPROCESSED COMPRESSION SLEEVES (K012597) | Sterilmed, Inc. | 2002-02-11 |
| MODIFICATION TO TRANSSEPTAL INTRODUCER SET (K020090) | Thomas Medical Products, Inc. | 2002-02-11 |
| JOSTRA DUAL STAGE VENOUS RETURN CANNULAE (K013944) | Jostra AG | 2002-02-11 |
| MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER (K020075) | Dolphin Medical, Inc. | 2002-02-08 |
| TASK FORCE MONITOR 3040 (K014063) | Cnsystems Medizintechnik GmbH | 2002-02-07 |
| CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM (K002604) | Invivo Research, Inc. | 2002-02-07 |
| VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07 (K011540) | Datascope Corp. | 2002-02-06 |
| CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENT (K012621) | Clearmedical, Inc. | 2002-02-06 |
| BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY (K013717) | Brentwood Medical Technology Corp. | 2002-02-06 |
| FUKUDA DENSHI DYNASCOPE MODEL DS-5700 (K020084) | Fukuda Denshi USA, Inc. | 2002-02-06 |
| CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCAST XL VENAFLOW CALF CUFF, CLEARMEDICAL/AIRCAST VENAFLOW THIGH (K012601) | Clearmedical, Inc. | 2002-02-06 |
| CLEARMEDICAL/KENDALL KNEE-HIGH SCD SLEEVES, CLEARMEDICAL/KENDALL THIGH-HIGH SCD SLEEVES, MEDIUM,SMALL, LARGE (K012606) | Clearmedical, Inc. | 2002-02-06 |
| CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS; MODELS FG200/LRG (LARGE), FG200/STD (STANDARD), FG100/SM (SMALL), FG100-R (REGULAR (K012616) | Clearmedical, Inc. | 2002-02-06 |
| CLEARMEDICAL/NOVAMEDIX AVI FOOT COVER, PAIR, REGULAR & LARGE SIZE (K012612) | Clearmedical, Inc. | 2002-02-06 |
| MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER (K012274) | Medtronic Physio-Control Corp. | 2002-02-05 |
| VASCUPUNCTURE ACCESS WIRE (K012861) | Neometrics, Inc. | 2002-02-05 |
| CENTRIFUGAL PUMP (K011838) | Stockert Instrumente GmbH | 2002-02-05 |
| ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER (K014016) | Minntech Corp. | 2002-02-01 |
| TM2000, MODEL 1 (K013879) | Card Guard Scientific Survival , Ltd. | 2002-02-01 |
| FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200 (K011901) | Survivalink Corp. | 2002-02-01 |
| DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410 (K020022) | Ge Medical Systems Information Technologies | 2002-02-01 |
| CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001 (K012241) | Cardionet, Inc. | 2002-02-01 |
| GLOBALCARDIO (K013354) | Cardiocomm Solutions, Inc. | 2002-01-31 |
| SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH (K014299) | Sorba Medical Systems, Inc. | 2002-01-30 |
| MEDITRON II THESTERTHOSCOPE SYSTEM (K013725) | Meditron AS | 2002-01-30 |
| METAVISION CLINICAL INFORMATION SYSTEM (K012349) | Imdsoft, Ltd. | 2002-01-29 |
| MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER (K020012) | Boston Scientific/Medi-Tech | 2002-01-29 |
| CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM (K012089) | Catheffects, LLC | 2002-01-28 |
| ULTRAMAX WOVEN VELOUR VASCULAR GRAFT (K013577) | Atrium Medical Corp. | 2002-01-25 |
| MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414 (K014294) | Medical Data Electronics | 2002-01-25 |
| MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM (K014223) | Medtronic Percusurge, Inc. | 2002-01-25 |
| EPS320 CARDIAC STIMULATOR (K011826) | Micropace Pty, Ltd. | 2002-01-24 |
| BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664 (K012749) | Biocardia, Inc. | 2002-01-24 |
| MULTI-SNARE SET (K011783) | Pfm Produkte Fur Die Medizin AG | 2002-01-24 |
| HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING (K012534) | Advanced Cardiovascular Systems, Inc. | 2002-01-24 |
| ANCURE SHEATH MODEL # 40315, 40320, 40325 (K003889) | Guidant Cardiac and Vascular Surgery | 2002-01-24 |
| PORTABLE INTENSIVE CARE UNIT (K012766) | Medical Research Laboratories, Inc. | 2002-01-23 |
| VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300) (K011625) | Vasocor, Inc. | 2002-01-23 |
| KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E (K010923) | Siemens Elema AB | 2002-01-23 |
| PUMP TUBING (K013578) | Terumo Cardiovascular Systems Corp. | 2002-01-22 |
| VANGUARD REPROCESSED INFLATION DEVICES (K012480) | Vanguard Medical Concepts, Inc. | 2002-01-22 |
| 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX (K020028) | Boston Scientific | 2002-01-22 |
| EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) (K013533) | General Devices | 2002-01-18 |
| PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM; PHILLIPS V24/V26 PATIENT MONITOR (K014159) | Philips Medical Systems, Inc. | 2002-01-18 |
| PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS (K014209) | Padpro, LLC | 2002-01-18 |
| HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A (K014157) | Philips Medical Systems | 2002-01-17 |
| INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325 (K012759) | Hutchinson Technology, Inc. | 2002-01-17 |
| ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORS (K013539) | Rossmax International , Ltd. | 2002-01-17 |
| ECG HOME (K012012) | H&C Medical Devices Spa | 2002-01-17 |
| SIEMENS INFINITY GATEWAY SUITE (K014213) | Siemens Medical Solutions USA, Inc. | 2002-01-17 |
| MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3BTO-1, WITH OPTIONAL THERMAL PRINTER, MODEL PR 1KA1 (K013485) | Microlife Corp. | 2002-01-17 |
| BARD CONQUEST PTA BALLOON DILATATION CATHETER (K014212) | C.R. Bard, Inc. | 2002-01-17 |
| ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE MONITORS (K013583) | Rossmax International , Ltd. | 2002-01-17 |
| HL168E (K014122) | Health & Life Co., Ltd. | 2002-01-16 |
| HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, #1009659,1009659J, 1009660, 10096 (K013833) | Guidant Corp. | 2002-01-16 |
| LUMEND PERCUTANEOUS CATHETER (K011562) | Lumend, Inc. | 2002-01-16 |
| NUMED COEFFICIENT PTV CATHETERS (K014124) | NuMED, Inc. | 2002-01-16 |
| SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE) (K014161) | St. Jude Medical, Inc. | 2002-01-15 |
| M2376A DEVICELINK SYSTEM, MODEL M2376A (K014181) | Philips Medical Systems, Inc. | 2002-01-15 |
| HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A (K013425) | Philips Medical Systems | 2002-01-14 |
| REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, AND TEMPLINK M EXTENSION CABLES (K013598) | C.R. Bard, Inc. | 2002-01-11 |
| MODIFICATION TO SUPERCROSS CATHETER (K014118) | Abbott Vascular, Inc. | 2002-01-11 |
| WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860 (K014121) | Nellcor Puritan Bennett, Inc. | 2002-01-11 |
| MODIFICATION TO OUTBACK CATHETER (K014117) | Lumend, Inc. | 2002-01-11 |
| INFINITY EXPLORER (K013515) | Siemens Medical Solutions USA, Inc. | 2002-01-10 |
| MAC 5000 ECG ANALYSIS SYSTEM (K014108) | General Electric Medical Systems Information Techn | 2002-01-10 |
| DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM (K013478) | Pulse Metric, Inc. | 2002-01-10 |
| DATEX-OHMEDA S/5 WEB VIEWER (K013387) | Datex-Ohmeda | 2002-01-08 |
| APEX ADULT HOLLOWE FIBER OXYGENATOR (K014080) | Dideco S.P.A. | 2002-01-08 |
| SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE) (K014037) | St. Jude Medical, Inc. | 2002-01-04 |
| NEOLEAD (K011564) | Neotech Products, Inc. | 2002-01-03 |
| NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR (K013319) | Nonin Medical, Inc. | 2002-01-03 |
| 3420 DIGIT PULSE OXIMETER, MODEL 3420 (K013171) | Bci, Inc. | 2002-01-03 |
| NUMED MULLINS PTA CATHETER (K013601) | NuMED, Inc. | 2002-01-03 |
| MODIFICATION TO: POCKETVIEW ECG SOFTWARE (K013311) | Micromedical Industries, Ltd. | 2002-01-03 |
| D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER (K013915) | Dideco S.P.A. | 2001-12-27 |
| ULTRA -THIN SDS BALLOON DILATATION CATHETER (K011889) | Boston Scientific Corp | 2001-12-21 |
| VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE (K011832) | Vanguard Medical Concepts, Inc. | 2001-12-21 |
| NORMATEC PCD (K013436) | Normatec, Inc. | 2001-12-21 |
| FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE (K013273) | Fukuda Denshi USA, Inc. | 2001-12-20 |
| GELBISH VASCULAR DILATOR (K012256) | Vascumetrix, LLC | 2001-12-20 |
| DATACAPTOR (K013019) | Capsule Technologie | 2001-12-18 |
| RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 (K013943) | Radi Medical Systems AB | 2001-12-18 |
| SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM (K011907) | Sims Level 1, Inc. | 2001-12-18 |
| JOSTRA FLOWPROBE FP-32E (K013939) | Jostra AG | 2001-12-14 |
| MODIFICATION TO THE GRIP (K010526) | Elcare Innovations, Inc. | 2001-12-13 |
| HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING (K013092) | Guidant Corp. | 2001-12-13 |
| DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM (K013358) | Pulse Metric, Inc. | 2001-12-13 |
| MEDRAD QWIK-FIT SYRINGE (K013815) | Medrad, Inc. | 2001-12-13 |
| CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH (K013367) | Reynolds Medical , Ltd. | 2001-12-13 |