| INTERLOCKING DETACHABLE COIL SYSTEM (IDC) (K040342) | Boston Scientific Corp | 2004-04-13 |
| BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90 (K040056) | Bio-Detek, Inc. | 2004-04-09 |
| PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005 (K040256) | Bio-Detek, Inc. | 2004-04-09 |
| AVITA BPM6 SERIES BLOOD PRESSURE METER (OR MONITOR), MODEL BPM6XY (K033397) | Avita Corporation | 2004-04-09 |
| TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418 (K033157) | Tanita Corp. of America | 2004-04-08 |
| PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU (K040569) | Oscor, Inc. | 2004-04-07 |
| PROTAB ECG TABB ELECTRODE (K040784) | Bio Protech, Inc. | 2004-04-07 |
| HRV TOOLS (K040313) | Del Mar Reynolds Medical, Ltd. | 2004-04-06 |
| SAFETYNET GUIDEWIRE INTRODUCER (K040029) | Injectimed, Inc. | 2004-04-05 |
| WELL@HOME SYSTEM (K040012) | Zoe Medical, Inc. | 2004-04-02 |
| ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER (K033875) | Cook, Inc. | 2004-04-02 |
| JSA'S REPROCESSED COMPRESSION SLEEVE DEVICES (K040065) | Jack Speer and Assoc., Inc. | 2004-03-29 |
| EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2 (K033050) | Medtronic Vascular | 2004-03-26 |
| CONTOUR SE MICROSPHERES (K034068) | Boston Scientific Corp | 2004-03-26 |
| NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC (K034025) | Nmt Medical, Inc. | 2004-03-26 |
| SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS: 64 62 910 E392E, 65 22 572 E397E, 65 03 655 (K024213) | Siemens Medical Solutions USA, Inc. | 2004-03-23 |
| CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F (K034050) | Cordis Corporation | 2004-03-22 |
| MODEL AVANT 2120 PULSE OXIMETER AND NIBP (K031487) | Nonin Medical, Inc. | 2004-03-22 |
| INFINITY MODULAR MONITORS VF4 MODIFICATIONS (K033694) | Draeger Medical Systems, Inc. | 2004-03-22 |
| APM BLOOD PRESSURE MONITOR, MODEL BP108A (K040159) | Asia Pacific Microsystems, Inc. | 2004-03-22 |
| MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1 (K040002) | Microlife Intellectual Property Gmb | 2004-03-22 |
| A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328 (K040229) | A&D Engineering, Inc. | 2004-03-19 |
| PEDIATRIC AORTIC ROOT CANNULA (K040173) | Medtronic Perfusion Systems | 2004-03-19 |
| MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V (K033998) | Masimo Corp. | 2004-03-19 |
| SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1 (K040481) | Intra Luminal Therapeutics, Inc. | 2004-03-18 |
| CORRESTORE PATCH SYSTEM (K040162) | Somanetics Corp. | 2004-03-16 |
| ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS (K040286) | Ethox Corp. | 2004-03-15 |
| ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS (K040298) | Acist Medical Systems, Inc. | 2004-03-15 |
| VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING (K040355) | Gish Biomedical, Inc. | 2004-03-15 |
| PROGREAT (K033913) | Terumo Medical Corp. | 2004-03-11 |
| AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 (K040453) | Revivant Corp. | 2004-03-11 |
| PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW 3031 AND EW 3032 (K033894) | Matsushita Electric Works, Ltd. | 2004-03-11 |
| DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422 (K033876) | Dolphin Medical, Inc. | 2004-03-11 |
| RNK TELEPHONIC STETHOSCOPE, MODEL TR-1 (K034046) | Rnk Products | 2004-03-10 |
| HEALTH BUDDY WITH BUDDYLINK (K040086) | Health Hero Network, Inc. | 2004-03-10 |
| INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER (K033807) | Draeger Medical Systems, Inc. | 2004-03-09 |
| STEERABLE STYLET (K040001) | Synovis Surgical Innovations | 2004-03-09 |
| TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002 (K033410) | Remote Diagnostic Technologies , Ltd. | 2004-03-05 |
| RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568 (K031903) | Guidant Corporation | 2004-03-03 |
| MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM (K040037) | Intra Luminal Therapeutics, Inc. | 2004-03-03 |
| M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II (K040357) | Philips Medical Systems, Inc. | 2004-03-03 |
| CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR (K040210) | Terumo Corp. | 2004-03-03 |
| PM-8000 PATIENT MONITOR, MODEL 8000 (K032733) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2004-03-03 |
| MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE (K033881) | Medrad, Inc. | 2004-03-02 |
| MODIFICATION TO NITREX NITINOL GUIDEWIRE (K040345) | Ev3, Inc. | 2004-03-02 |
| ARROW ECHOGENIC INTRODUCER NEEDLE (K040100) | Arrow Intl., Inc. | 2004-03-01 |
| CAPIOX FLEXIBLE VENOUS RESERVOIR (K040023) | Terumo Cardiovascular Systems Corp. | 2004-03-01 |
| MODIFIED SONAMET BODY COMPOSITION ANALYZER (K032610) | Life Measurement, Inc. | 2004-03-01 |
| PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP40 & MP50 (K040304) | Philips Medizin Systeme Boeblingen GmbH | 2004-03-01 |
| VITAL SIGNS MONITOR, PROPAQ LT (K033378) | Welch Allyn Protocol, Inc. | 2004-03-01 |
| EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY (K033617) | Vasomedical, Inc. | 2004-03-01 |
| EP-4 CLINICAL STIMULATOR (K040207) | Ep Medsystems | 2004-02-27 |
| AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE (K032421) | Ambu, Inc. | 2004-02-27 |
| CENTRAL STATION, VERSION 3.3H (K040032) | Hommed, LLC | 2004-02-27 |
| BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR (K033771) | Bio-Detek, Inc. | 2004-02-27 |
| DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER (K040184) | Cobe Cardiovascular, Inc. | 2004-02-26 |
| CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT (K040252) | Rex Medical | 2004-02-26 |
| ENVOY PATIENT MONITOR (K030722) | Mennen Medical, Inc. | 2004-02-26 |
| MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K040214) | Masimo Corp. | 2004-02-25 |
| GOLDWAY UT4000A VITAL SIGNS MONITOR (K033988) | Goldway (Us), Inc. | 2004-02-25 |
| ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER (K033650) | Siemens Medical Solutions USA, Inc. | 2004-02-24 |
| DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-1862 (K040309) | Nihon Seimitsu Sokki Co., Ltd. | 2004-02-24 |
| CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM (K033030) | Witt Biomedical Corp | 2004-02-24 |
| SKINTACT ECG ELECTRODE (K040249) | Leonhard Lang GmbH | 2004-02-24 |
| CREATION NM DIAGNOSTIC CATHETERS (K032888) | Neich Medical (Shenzhen) Company Limited | 2004-02-24 |
| SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038 (K033678) | Spectranetics Corp. | 2004-02-23 |
| PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T (K032979) | Philips Medical Systems, Inc. | 2004-02-20 |
| MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR (K032551) | Masimo Corp. | 2004-02-19 |
| MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V (K033296) | Masimo Corp. | 2004-02-19 |
| GELSOFT PLUS ERS (K034010) | Vascutek, Ltd. | 2004-02-19 |
| MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER (K040150) | Medamicus, Inc. | 2004-02-18 |
| VASCON POLARIS GUIDING CATHETER (K033633) | Vascon, LLC | 2004-02-18 |
| ENDOBIONICS MICROSYRINGE (USYRINGE) INFUSION CATHETER (K040139) | Endobionics, Inc. | 2004-02-18 |
| MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055 (K034036) | Micro Therapeutics, Inc. | 2004-02-13 |
| PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER (K033715) | Philips Medical Systems, Inc. | 2004-02-13 |
| NOVOSCI READY SYSTEM, MODEL RS-200 (K033270) | Novosci Corp. | 2004-02-13 |
| ECHO SOUNDER EX-101EX 8 MHZ (K031931) | Koven Technology, Inc. | 2004-02-13 |
| BARD ATLAS PTA BALLOON DILATATION CATHETER (K040243) | C.R. Bard, Inc. | 2004-02-13 |
| VICEROY INFLATION DEVICE (K040138) | Merit Medical Systems, Inc. | 2004-02-13 |
| WFSI'S REPROCESSED COMPRESSION SLEEVE DEVICES (K033615) | Wheaton Franciscan Services Inc., Supply Chain | 2004-02-13 |
| IQ GUIDE WIRE (K040140) | Boston Scientific Corp | 2004-02-12 |
| OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XL (K032305) | Omron Healthcare, Inc. | 2004-02-11 |
| TRIO MONITOR MODEL 0998-00-0600 (K032338) | Datascope Corp. | 2004-02-11 |
| POLARCATH PERIPHERAL DILATATION SYSTEM (K033622) | Cryo Vascular Systems, Inc. | 2004-02-10 |
| CAPIOX CARDIOTOMY RESERVOIR (K033800) | Terumo Cardiovascular Systems Corporation | 2004-02-10 |
| CSTAT, MODELS 09-0014-01 AND 09-0014-02 (K032125) | Vascular Control Systems, Inc. | 2004-02-09 |
| INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER (K033527) | B.Braun Medical, Inc. | 2004-02-05 |
| HEARTRAK SMART AT/HEARTRAK SMART2 (K033451) | Universal Medical, Inc. | 2004-02-05 |
| SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110 (K033997) | Bacchus Vascular, Inc. | 2004-02-04 |
| PRESS-MATE BX-10 VITAL SIGN MONITOR (K032857) | Colin Medical Instruments Corp. | 2004-02-04 |
| JOSTRA SUCKERS, MODEL JS (K020983) | Jostra AG | 2004-01-30 |
| MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH (K034061) | Boston Scientific Corp | 2004-01-30 |
| SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011 (K034058) | Medtronic Vascular | 2004-01-29 |
| HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX (K031167) | Idt Technology Limited | 2004-01-28 |
| AC-1 SP02 ADAPTOR CABLE, MODEL AC-1 (K033349) | Masimo Corp. | 2004-01-28 |
| RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100 (K032882) | Recom Managed Systems, Inc. | 2004-01-28 |
| SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 (K023713) | Sontra Medical, Inc. | 2004-01-28 |
| MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69 (K033989) | Medtronic Inc. Cardiac Rhythm Management | 2004-01-22 |
| NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT (K033328) | Novosci Corp. | 2004-01-16 |
| PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER (K033726) | Precision Vascular | 2004-01-16 |