| PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES) (K023616) | Ivy Biomedical Systems, Inc. | 2002-11-04 |
| SIEMENS MULTIVIEW WORKSTATION MODIFICATIONS (K023569) | Siemens Medical Solutions USA, Inc. | 2002-11-04 |
| PHLEBOTEST 2000 (K022047) | Osborn Medical Corp. | 2002-11-04 |
| WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK) (K023495) | Welch Allyn, Inc. | 2002-10-31 |
| MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F) (K023447) | St Jude Medical | 2002-10-31 |
| EXPORT ASPIRATION CATHETER (K023303) | Medtronic Vascular | 2002-10-29 |
| HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPER MS CS-J; HI-TORQUE WHISPER ES; HI-TORQUE WHISPER ES CS-J (K023300) | Guidant Corp. | 2002-10-28 |
| ARTERIA OCCLUSION BALLOON (K021210) | Arteria Medical Science, Inc. | 2002-10-28 |
| MEDCOMP VASCU-SHEATH INTRODUCER SET (K022513) | Medcomp | 2002-10-25 |
| CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES (K023475) | Nihon Kohden America, Inc. | 2002-10-24 |
| MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER (K023223) | Lumend, Inc. | 2002-10-24 |
| CARDIO ID+(RZ153+) (K022540) | Rozinn Electronics, Inc. | 2002-10-24 |
| INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY (K022450) | Dideco S.P.A. | 2002-10-22 |
| BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-200 (K023055) | Vsm Medtech , Ltd. | 2002-10-22 |
| SMITHWICK CAROTID SHUNT (K021608) | Implantable Devices | 2002-10-22 |
| AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP (K023099) | Biotronik, Inc. | 2002-10-18 |
| CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B (K023116) | Cordis Corp. | 2002-10-18 |
| TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815 (K022357) | Boston Scientific, Target | 2002-10-16 |
| S&T SINGLE USE MICRO ANASTOMOSIS CLAMP (K022754) | S & T AG | 2002-10-16 |
| NEICH NM ADVANCE CATHETER SHEATH INTRODUCER (K020964) | Neich Medical(Shenzhen)Company, Ltd. | 2002-10-11 |
| MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5 (K022117) | Merit Medical Systems, Inc. | 2002-10-11 |
| REPROCESSED IMAGING CATHETERS (K012537) | Sterilmed, Inc. | 2002-10-11 |
| STOCKERT CORONARY PERFUSION CANNULAE (K022280) | Stockert Instrumente GmbH | 2002-10-11 |
| HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300; SOUNDS EASY AUSCULTATION SOFTWARE (K021087) | Erecords Limited | 2002-10-11 |
| VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K022316) | Vanguard Medical Concepts, Inc. | 2002-10-10 |
| MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 (K022238) | Medtronic Vascular | 2002-10-09 |
| STOCKERT V172-28 VENOUS FEMORAL CANNULA (K022321) | Stockert Instrumente GmbH | 2002-10-09 |
| TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES (K021955) | Datex-Ohmeda, Inc. | 2002-10-08 |
| MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650 (K022210) | Cardiac Science, Inc. | 2002-10-04 |
| VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX (K022257) | Vomed Volzer Medizintechnik GmbH & Co. | 2002-10-04 |
| VANGUARD REPROCESSED PULSE OXIMETER SENSORS (K012344) | Vanguard Medical Concepts, Inc. | 2002-10-04 |
| OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES (K022939) | Osypka Medical, Inc. | 2002-10-03 |
| RADIANALYZER, MODEL 12710 (K022188) | Radi Medical Systems AB | 2002-10-03 |
| DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AND L-CANE02A SOFTWARE (K022485) | Datex-Ohmeda | 2002-10-03 |
| BIOVER (K011208) | Biover AG | 2002-10-02 |
| I-STETHOS LINK (K022298) | Andromed, Inc. | 2002-10-01 |
| UNITY NETWORK ID (K021454) | General Electric Medical Systems Information Techn | 2002-10-01 |
| QIVA (K021495) | Pie Medical Imaging BV | 2002-10-01 |
| LIVESIRE ELECTROPHYSIOLOGY CATHETER (K022380) | St Jude Medical | 2002-10-01 |
| BIOLOGICAL SOUND MONITOR (BSM) SENSOR (K021389) | Andromed, Inc. | 2002-10-01 |
| ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER (K022552) | Cook, Inc. | 2002-09-27 |
| GLOBAL ECG MANAGEMENT SYSTEM (GEMS) (K022297) | Cardiocomm Solutions, Inc. | 2002-09-27 |
| CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR (K022115) | Terumo Corp. | 2002-09-27 |
| ATLAS MONITOR, MODELS 200,210,220 (K022084) | Welch Allyn, Inc. | 2002-09-26 |
| SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 & SC 9000XL & SIEMENS INFINITY EXPLORER (K022889) | Siemens Medical Solutions USA, Inc. | 2002-09-25 |
| CARDIS (K023015) | Schwarzer GmbH | 2002-09-25 |
| PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304 (K022187) | Radi Medical Systems AB | 2002-09-24 |
| NELLCOR N-200 PULSE OXIMETER, MODEL N-200 (K022819) | Nellcor Puritan Bennett, Inc. | 2002-09-24 |
| SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028 (K022138) | Spectranetics Corp. | 2002-09-23 |
| STOCKERT CENTRIFUGAL PUMP CONSOLE (K020571) | Stockert Instrumente GmbH | 2002-09-23 |
| CHASE CARDIOVASCULAR PATCH KIT (K022093) | Chase Medical, Inc. | 2002-09-20 |
| CVSI PERIPHERAL BALLOON CATHETER; CVSI INFLATER (K022061) | Cryo Vascular Systems, Inc. | 2002-09-20 |
| DVT60 (K022786) | Huntleigh Healthcare, Inc. | 2002-09-19 |
| SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND) (K022363) | St. Jude Medical, Inc. | 2002-09-19 |
| DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5 (K022075) | Cp Medical | 2002-09-19 |
| PUMP TUBING WITH X-COATING (K022857) | Terumo Cardiovascular Systems Corporation | 2002-09-19 |
| WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506 (K022163) | Welch Allyn, Inc. | 2002-09-17 |
| M2376A DEVICELINK SYSTEM (K022920) | Philips Medical Systems | 2002-09-17 |
| PTA AND PTV (K022722) | NuMED, Inc. | 2002-09-13 |
| DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11 (K014141) | Digibio Technology Corp. | 2002-09-13 |
| TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305 (K022003) | Micro Therapeutics, Inc. | 2002-09-13 |
| AGILTRAC .035 PERIPHERAL DILATATION CATHETER (K022738) | Guidant Corp. | 2002-09-13 |
| GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500 (K022880) | Guidant Corp. | 2002-09-13 |
| PRESS-MATE PM-2100 VITAL SIGN MONITOR (K022537) | Colin Medical Instruments Corp. | 2002-09-13 |
| MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE (K022677) | Alaris Medical Systems, Inc. | 2002-09-11 |
| JOSTRA VENT CATHETERS, MODELS LV & HKV (K022022) | Jostra AG | 2002-09-11 |
| X-SCRIBE II (K022618) | Mortara Instrument, Inc. | 2002-09-06 |
| SIEMENS MEDICAL INFORMATION BUS (MIB/MIB II/MIB DUO) PROTOCOL COVERTER (K022766) | Siemens Medical Solutions USA, Inc. | 2002-09-05 |
| AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101 (K020693) | Embol-X, Inc. | 2002-09-05 |
| QUINTON Q-CATH, MODEL 000460 (K021906) | Quinton, Inc. | 2002-09-04 |
| BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER (K022621) | Boston Scientific Corp | 2002-09-04 |
| MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC) (K022042) | Cardeon Corp. | 2002-09-03 |
| 7F LAUNCHER GUIDE CATHETER (K022764) | Medtronic Vascular | 2002-08-28 |
| PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX (K020550) | Datascope Corp. | 2002-08-28 |
| LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2 (K020529) | A-Med Systems, Inc. | 2002-08-26 |
| DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02 (K022507) | Datex-Ohmeda | 2002-08-23 |
| MODIFICATION TO MEDAMICUS AXIA RSN (K022689) | Medamicus, Inc. | 2002-08-23 |
| BOLTON PTA CATHETER (K021996) | Bolton Medical, Inc. | 2002-08-23 |
| 3T VESSEL CANNULAS (K020768) | 3t Medical Systems, LLC | 2002-08-23 |
| COSMOS SYSTEM (K013046) | Spacelabs Medical, Inc. | 2002-08-21 |
| REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP (K021528) | Adven Medical | 2002-08-21 |
| MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM (K022453) | Welch Allyn Protocol, Inc. | 2002-08-21 |
| PALMO THERMOREGULATION INTERFACE ACCESSORY (K014210) | Avacore Technologies, Inc. | 2002-08-16 |
| TL10 TENSYMETER BLOOD PRESSURE MONITORING SYSTEM (K020537) | Tensys Medical, Inc. | 2002-08-15 |
| AUTOPULSE RESUSCITATION SYSTEM (K022345) | Revivant Corp. | 2002-08-15 |
| 507EL VITAL SIGNS MONITOR (K022435) | Criticare Systems, Inc. | 2002-08-14 |
| INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER (K022242) | Intervascular | 2002-08-14 |
| SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010 (K013038) | Polystan A/S | 2002-08-14 |
| REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS (K012678) | Sterilmed, Inc. | 2002-08-14 |
| DASH 3000/4000 PATIENT MONITOR (K020290) | General Electric Medical Systems Information Techn | 2002-08-14 |
| ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS (K020984) | Access Cardiosystems, Inc. | 2002-08-14 |
| REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS (K012523) | Sterilmed, Inc. | 2002-08-14 |
| ELECTROPHYSIOLOGY CATHETER (K012708) | Alliance Medical Corp. | 2002-08-13 |
| SENSA-CUFF, MODELS INFANT, CHILD, ADULT (K022482) | Ge Medical Systems Information Technologies | 2002-08-13 |
| FLEXLINE CLAMP (K010727) | Novare Surgical Systems, Inc. | 2002-08-09 |
| SHEATH ADAPTER, MODEL SA-09847 (K021723) | Arrow Intl., Inc. | 2002-08-08 |
| CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 (K022107) | Cardiomedics, Inc. | 2002-08-08 |
| BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER (K021735) | Boston Scientific Scimed, Inc. | 2002-08-08 |
| ROSSMAX AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODELS B150 & Q400 (K020897) | Rossmax Internationl , Ltd. | 2002-08-06 |
| SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045 (K022281) | Polystan A/S | 2002-08-06 |