| CAIRD TECHNOLOGY HOLTER 2000 (K012686) | Caird Technology | 2001-12-13 |
| MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K013792) | Masimo Corp. | 2001-12-11 |
| DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01 (K013246) | Datex-Ohmeda | 2001-12-11 |
| CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING (K010443) | Terumo Cardiovascular Systems Corp. | 2001-12-11 |
| EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 (K013789) | Boston Scientific, Target | 2001-12-06 |
| MODIFICATION TO VIKING OPTIMA GUIDING CATHETER (K013638) | Guidant Corp. | 2001-12-04 |
| MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR. (K013013) | Medtronic Cardiac Surgical Products | 2001-12-04 |
| SELECTIVA GUIDEWIRE (K013024) | Neometrics, Inc. | 2001-12-04 |
| LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR (K011144) | Medtronic Physio-Control Corp. | 2001-12-03 |
| MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V26 PATIENT MONITORS, BLOOD ANALYSIS PORTAL SYSTEM PLUG-I (K013624) | Philips Medizin Systeme Boblingen GmbH | 2001-12-03 |
| LYMPHA PRESS PLUS DEVICE (K013331) | Mego Afek | 2001-11-30 |
| MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR, MODELS PHILIPS M3000A/M3046A (K013427) | Philips Medical Systems, Inc. | 2001-11-29 |
| CORDIS AVIATOR PERIPHERAL DILATATION CATHETER (K013581) | Cordis, A Johnson & Johnson Co. | 2001-11-28 |
| PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENENT RACK, MODEL M1276B (K013199) | Philips Medical Systems, Inc. | 2001-11-28 |
| COMPRESSIBLE LIMB SLEEVE (K011192) | Alliance Medical Corp. | 2001-11-26 |
| MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS (K013564) | Cambridge Heart, Inc. | 2001-11-21 |
| RENAL GUIDING SHEATH (K012854) | Terumo Medical Corp. | 2001-11-21 |
| CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS (K011487) | Somanetics Corp. | 2001-11-21 |
| STENT SUPPORT GUIDE CATHETER (K010579) | Medtronic Vascular | 2001-11-21 |
| CARTO XP EP NAVIGATION SYSTEM (K013083) | Biosense Webster, Inc. | 2001-11-21 |
| CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 (K013565) | Cambridge Heart, Inc. | 2001-11-21 |
| POWERHEART CARDIAC RHYTHM MODULE (K012197) | Cardiac Science, Inc. | 2001-11-16 |
| JOSTRA ARTERIAL PERFUSION CANNULAE (K012774) | Jostra AG | 2001-11-16 |
| COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR (K013480) | Cobe Cardiovascular, Inc. | 2001-11-16 |
| SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM (K012763) | Cobe Cardiovascular, Inc. | 2001-11-15 |
| CAPIOX RX HARDSHELL RESERVOIR (K013526) | Terumo Cardiovascular Systems Corp. | 2001-11-15 |
| MODIFICATION TO M2376A DEVICELINK SYSTEM (K013470) | Philips Medical Systems, Inc. | 2001-11-14 |
| CAROTID GUIDING SHEATH (K012812) | Terumo Medical Corp. | 2001-11-14 |
| N2000 BASE STATION, N2001 NURSE STATION (K012801) | Neptec Design Group, Ltd. | 2001-11-14 |
| TONOPORT V (K012647) | Par Medizintechnik GmbH | 2001-11-09 |
| HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H (K013393) | A-Med Systems, Inc. | 2001-11-09 |
| PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS (K013339) | Oscor, Inc. | 2001-11-08 |
| BODY FAT ANALYZER, MODEL HBF-306 (K011652) | Omron Healthcare, Inc. | 2001-11-07 |
| JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A... (K012617) | Jostra AG | 2001-11-06 |
| PF 5050 PRESSURE UNIT, MODEL PF 5050 (K011899) | Perimed AB | 2001-11-06 |
| THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500 (K012942) | Circulatory Technology, Inc. | 2001-11-05 |
| DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX (K012531) | Datex-Ohmeda | 2001-11-02 |
| MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR (K011439) | Cardiodynamics International Corp. | 2001-11-02 |
| OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE OPTICAL SENDOR (K012626) | Osi Medical, Inc. | 2001-11-02 |
| MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B (K013326) | Datascope Corp. | 2001-11-02 |
| ADC 656 ELECTRONIC STETHOSCOPE (K012304) | American Diagnostic Corp. | 2001-11-01 |
| DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM (K012498) | Pulse Metric, Inc. | 2001-11-01 |
| MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT (K011761) | Arrow Intl., Inc. | 2001-10-31 |
| TM2000 EASYTRACE PLUS RECEIVING CENTER (K013175) | Card Guard Scientific Survival , Ltd. | 2001-10-30 |
| STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE (K001509) | Cobe Cardiovascular, Inc. | 2001-10-26 |
| AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A (K010729) | Andromed, Inc. | 2001-10-26 |
| BPTRU AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 (K012636) | Vsm Technology, Inc. | 2001-10-26 |
| GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT (K013250) | W. L. Gore & Associates, Inc. | 2001-10-26 |
| VITALSAT PULSE OXIMETER, MODEL IC32000 (K011365) | Island Critical Care Corp. | 2001-10-26 |
| VENODYNE DVT ADVANTAGE PLUS (K011318) | Microtek Medical, Inc. | 2001-10-25 |
| AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE (K012141) | External Counterpulsation Lab | 2001-10-25 |
| AUTOPULSE, MODEL 100 (K011046) | Revivant Corp. | 2001-10-25 |
| 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 (K012143) | Medtronic Cardiac Surgical Products | 2001-10-24 |
| ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD (K011056) | Arrow Intl., Inc. | 2001-10-24 |
| MODIFICATION TO: HL168W TOUCH SCREEN (K013033) | Health & Life Co., Ltd. | 2001-10-23 |
| MODIFICATION TO BRAIDED GUIDING INTRODUCER (K013202) | Thomas Medical Products, Inc. | 2001-10-23 |
| TELEPRESS III BLOOD PRESSURE MONITOR, MODEL TPIII (K011058) | Meridian Medical Technologies , Ltd. | 2001-10-23 |
| MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM (K013156) | Data Critical Corp. | 2001-10-19 |
| STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES (K003857) | Sterilmed, Inc. | 2001-10-18 |
| VANGUARD REPROCESSED COMPRESSION GARMENT (K012403) | Vanguard Medical Concepts, Inc. | 2001-10-17 |
| FLEXI-SITE SP02 EAR SENSOR (K012333) | Epic Medical Equipment Services, Inc. | 2001-10-17 |
| LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES (K012218) | The Ludlow Company LP | 2001-10-12 |
| K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 (K012404) | Katecho, Inc. | 2001-10-12 |
| ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM (K012206) | Cambridge Heart, Inc. | 2001-10-12 |
| INSTRUMENT DAMPING PORT (K011373) | Medcanica, Inc. | 2001-10-12 |
| MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC (K012264) | National Custom Ent., Inc. | 2001-10-10 |
| MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024 (K012263) | National Custom Ent., Inc. | 2001-10-10 |
| CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031 (K010954) | Concentric Medical, Inc. | 2001-10-09 |
| SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515 (K013029) | St Jude Medical | 2001-10-09 |
| THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER (K010706) | Measurement Specialties, Inc. | 2001-10-05 |
| INTERCOSTAL LOCKABLE-DIRECTABLE PORT (K011349) | Medcanica, Inc. | 2001-10-05 |
| MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM (K012950) | Medrad, Inc. | 2001-10-04 |
| C. NET 2100 (K010396) | Cardionetics, Ltd. | 2001-10-04 |
| MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR (K004001) | Dideco | 2001-10-04 |
| MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS AND CABLES (K012992) | Masimo Corp. | 2001-10-03 |
| MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500 (K012336) | Medical Data Electronics | 2001-10-03 |
| SMARTFLOW (K012947) | Florence Medical , Ltd. | 2001-10-02 |
| HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT (K012952) | Boston Scientific/Medi-Tech | 2001-10-02 |
| BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER (K012913) | C.R. Bard, Inc. | 2001-09-28 |
| MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 (K012926) | Endocardial Solutions, Inc. | 2001-09-28 |
| 2010 PLUS HOLTER FOR WINDOWS (K010949) | Agilent Technologies | 2001-09-28 |
| MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR (K012428) | Medtronic Physio-Control Corp. | 2001-09-28 |
| VYGON SPLIT CANNULA INTRODUCER (K010913) | Vygon Corp. | 2001-09-28 |
| VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM) (K010732) | Telemedic Systems, Inc. | 2001-09-27 |
| AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T (K013084) | Medtronic Perfusion Systems | 2001-09-27 |
| DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR (K010478) | Dideco | 2001-09-27 |
| BLY-501 ADAPTOR (K012540) | Micromedical Industries, Ltd. | 2001-09-26 |
| ULTRAFLEX EV HEMOSTASIS INTRODUCER (K012922) | St Jude Medical | 2001-09-25 |
| PORTABLE INTENSIVE CARE UNIT (K012030) | Medical Research Laboratories, Inc. | 2001-09-24 |
| STS RANGE , MODELS STS20,STS30,STS40 (K012008) | Huntleigh Healthcare, Inc. | 2001-09-21 |
| PRECLUDE PERICARDIAL MEMBRANE (K012098) | W. L. Gore & Associates, Inc. | 2001-09-20 |
| MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM (K012898) | Cobe Cardiovascular, Inc. | 2001-09-17 |
| TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P) (K012747) | Medtronic Perfusion Systems | 2001-09-14 |
| TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T (K012743) | Medtronic Perfusion Systems | 2001-09-14 |
| E-STETH ELECTRONIC STETHOSCOPE (K011898) | E-Med Innovations, Inc. | 2001-09-14 |
| MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES (K012837) | Datex-Ohmeda | 2001-09-14 |
| ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825 (K011980) | Pace Medical | 2001-09-12 |
| NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES (K011918) | Nihon Kohden America, Inc. | 2001-09-12 |
| CG-2211 SELFCHECK ECG TRANSMITTER (K012223) | Card Guard Scientific Survival , Ltd. | 2001-09-10 |
| IMAGER II ANGIOGRAPHIC CATHETER (K011664) | Boston Scientific/Medi-Tech | 2001-09-07 |