| MODEL 3100 WRISTOX PULSE OXIMETER (K030668) | Nonin Medical, Inc. | 2003-10-17 |
| RADIUS COUGAR WIRE (K032899) | Radius Medical Technologies, Inc. | 2003-10-17 |
| UUHC REPROCESSED COMPRESSION SLEEVE DEVICES (K031189) | University of Utah Hospitals and Clinics | 2003-10-16 |
| MODIFICATION TO: HORIZON 9000WS (K032997) | Mennen Medical , Ltd. | 2003-10-15 |
| DIGITAL AMBULATORY ECG (HOLTER) RECORDER (K031074) | Datrix | 2003-10-15 |
| EKG SPEAKS (K032926) | Medtronic Vascular | 2003-10-15 |
| EKOS PERIPHERAL INFUSION SYSTEM (K033214) | Ekos Corp. | 2003-10-14 |
| HL888BM (K032837) | Health & Life Co., Ltd. | 2003-10-10 |
| THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O. (K032858) | Philips Medizin Systeme Boblingen GmbH | 2003-10-10 |
| FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOR (K032290) | Fukuda Denshi USA, Inc. | 2003-10-10 |
| CAREMATIX WELLNESS SYSTEM (K031840) | Carematix, Inc. | 2003-10-10 |
| CARESTATION 126S VIDEOPHONE (K031863) | Motion Media Technology, Inc. | 2003-10-10 |
| MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM (K032577) | Ge Medical Systems Information Technologies | 2003-10-10 |
| HL888BA (K032839) | Health & Life Co., Ltd. | 2003-10-10 |
| VIEWPOINT TELEMETRY SYSTEM (K031760) | Datascope Corp. | 2003-10-10 |
| MODIFICATION TO HL168 (K033043) | Health & Life Co., Ltd. | 2003-10-10 |
| CUF-COVER (TM) (K031195) | Ethox Corp. | 2003-10-10 |
| MODEL 2100 PULSE OXIMETER (K031465) | Dolphin Medical, Inc. | 2003-10-10 |
| JS VASCULAR GUIDE WIRE VISE/TORQUE DEVICE (K032411) | Js Vascular, Inc. | 2003-10-07 |
| HEART 2006 (K032736) | Aerotel Medical Systems (1998) , Ltd. | 2003-10-03 |
| ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH (K032200) | Remco Italia S.P.A. | 2003-10-03 |
| REPROCESSED ELECTROPHYSIOLOGY CATHETER (K030279) | Alliance Medical Corp. | 2003-10-03 |
| CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA (K032737) | Cordis Europa, N.V. | 2003-10-02 |
| EDWARDS PERIPHERAL DILATATION CATHETER (K032587) | Edwards Lifesciences, LLC | 2003-10-02 |
| HL888 AF (K032913) | Health & Life Co., Ltd. | 2003-10-02 |
| HL888BF (K032695) | Health & Life Co., Ltd. | 2003-10-02 |
| CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W (K031922) | Merit Medical Systems, Inc. | 2003-10-01 |
| VASCUPUNCTURE PICC GUIDEWIRE (K031652) | Neometrics, Inc. | 2003-09-30 |
| RINSPIRATION SYSTEM (K031485) | Kerberos Proximal Solutions | 2003-09-25 |
| NUMED TYSHAK MINI PEDIATRIC PTV CATHETER (K032591) | NuMED, Inc. | 2003-09-25 |
| REPROCESSED ELECTROPHYSIOLOGY CATHETER (K030187) | Alliance Medical, Inc. | 2003-09-24 |
| ROWENTA INC. BODYPARTNER VISION, MODEL BM 210 (2079565620) (K023429) | Rowenta, Inc. | 2003-09-23 |
| CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER (K030966) | Boston Scientific Corp | 2003-09-23 |
| UNITY NETWORK PATIENT DATA SERVER (K032582) | Ge Medical Systems Information Technologies | 2003-09-17 |
| GALIX WINTER (K030145) | Galix Biomedical Instrumentation, Inc. | 2003-09-17 |
| PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16 (K031948) | Pm Devices, Inc. | 2003-09-16 |
| AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060 (K030504) | Idev Technologies, Inc. | 2003-09-16 |
| SHORT INTRODUCER SHEATH (K032569) | Rex Medical | 2003-09-16 |
| ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300 (K032615) | Asahi Intecc Co., Ltd. | 2003-09-16 |
| BEDSIDE MONITOR, MODEL OPV-1500 (K032749) | Nihon Kohden America, Inc. | 2003-09-16 |
| MICRUS MICROCATHETER (K032624) | Micrus Corp. | 2003-09-10 |
| SELDINGER SAFETY NEEDLE INTRODUCER (K032404) | Hdc Corp. | 2003-09-10 |
| PATHWAY ACCESS SHEATH CATHETER (K030734) | Vertelink Corporation | 2003-09-10 |
| INFINITY MEGACARE (K031970) | Siemens Medical Solutions USA, Inc. | 2003-09-09 |
| AMPLATZER VASCULAR PLUG (K031810) | Aga Medical Corp. | 2003-09-09 |
| SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX (K031849) | Datascope Corp. | 2003-09-09 |
| BLOOD PRESSURE MONITOR, MODEL KP-7000 (K032492) | K-Jump Health Co., Ltd. | 2003-09-09 |
| ENCLOSE II ANASTOMOSIS ASSIST DEVICE (K032589) | Novare Surgical Systems, Inc. | 2003-09-05 |
| BPCARD (K031964) | Qrs Diagnostic, LLC | 2003-09-05 |
| PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601 (K032038) | Quinton, Inc. | 2003-09-05 |
| PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER (K032494) | Precision Vascular Systems, Inc. | 2003-09-05 |
| MACROPORE CARDIO-WRAP (TS) (K031785) | Macropore Biosurgery, Inc. | 2003-09-04 |
| ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR (K032491) | Imagyn Medical Technologies, Inc. | 2003-09-04 |
| DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER (K030629) | Dolphin Medical, Inc. | 2003-09-04 |
| ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS (K032622) | Medtronic Vascular | 2003-09-03 |
| MERIT MAK (MINI ACCESS KIT) (K031691) | Merit Medical Systems, Inc. | 2003-09-03 |
| EDWARDS DIRECTIONAL CATHETER (K030630) | Edwards Lifesciences, LLC | 2003-09-03 |
| POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM (K030742) | Cryo Vascular Systems, Inc. | 2003-08-29 |
| STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP (K032213) | Stockert Instrumente GmbH | 2003-08-29 |
| MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711 (K031700) | Medtronic Perfusion Systems | 2003-08-29 |
| HEARTSTART MRX, MODEL M3535A (K031187) | Philips Medical Systems | 2003-08-27 |
| MOBILE BATTERY SERVICE STATION (MBSS) (K030898) | Ad Elektronik GmbH | 2003-08-27 |
| DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM) (K032041) | LeMaitre Vascular, Inc. | 2003-08-27 |
| CLICK HOLTER (K032276) | Remco Italia S.P.A. | 2003-08-27 |
| WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (K032069) | AngioDynamics, Inc. | 2003-08-27 |
| ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER (K032376) | AngioDynamics, Inc. | 2003-08-26 |
| VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES (K031740) | Welch Allyn Protocol, Inc. | 2003-08-26 |
| GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200 (K032250) | Edwards Lifesciences, LLC | 2003-08-26 |
| MODIFICATION TO OUTBACK CATHETER (K032298) | Lumend, Inc. | 2003-08-26 |
| HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING (K031678) | Guidant Corp. | 2003-08-26 |
| SPIDERVIEW (K032466) | Ela Medical, Inc. | 2003-08-22 |
| SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 (K031692) | Intra Luminal Therapeutics, Inc. | 2003-08-22 |
| Trellis Reserve Infusion System (K032261) | Bacchus Vascular, Inc. | 2003-08-22 |
| CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200 (K032068) | Cardiovention, Inc. | 2003-08-22 |
| EP-WORKMATE WITH RPM SYSTEM (K032225) | Ep Medsystems | 2003-08-20 |
| QUANTIX/OR DEVICE (K030357) | Cardiosonix, Ltd. | 2003-08-20 |
| NX SYSTEM (K030222) | American Telecare, Inc. | 2003-08-19 |
| SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH VF3 MODIFICATIONS (K031433) | Siemens Medical Solutions USA, Inc. | 2003-08-19 |
| BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER (K031742) | Bci, Inc. | 2003-08-18 |
| MODIFICATION TO: APEXPRO TELEMETRY SYSTEM (K032369) | Ge Medical Systems Information Technologies | 2003-08-15 |
| GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE (K032073) | W. L. Gore & Associates, Inc. | 2003-08-13 |
| CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION (K032370) | Ge Medical Systems Information Technologies | 2003-08-13 |
| PBN GUIDEWIRES (K031442) | Medical Device Technologies, Inc. | 2003-08-13 |
| PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES (K032146) | Precision Vascular Systems, Inc. | 2003-08-12 |
| CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX (K031636) | Datascope Corp. | 2003-08-11 |
| PERIVAC KIT (K032050) | Boston Scientific Corp | 2003-08-08 |
| DATACAPTOR (K032142) | Capsule Technologie | 2003-08-08 |
| ELECTROPHYSIOLOGY CATHETER (K030109) | Alliance Medical Corp. | 2003-08-08 |
| AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR) (K030316) | Inovise Medical, Inc. | 2003-08-07 |
| ECHELON MICRO CATHETER, MODEL 105-5091 (K031992) | Micro Therapeutics, Inc. | 2003-08-07 |
| CORRESTORE PATCH SYSTEM (K031586) | Somanetics Corp. | 2003-08-07 |
| HEATER COOLER UNIT, MODEL HCU 30 (K031544) | Jostra AB | 2003-08-07 |
| CARDIOQ, MODEL 9051-7005 (K031706) | Deltex Medical | 2003-08-06 |
| UNITY NETWORK IS PATIENT VIEWER (K032346) | Ge Medical Systems Information Technologies | 2003-08-05 |
| LIFESYNE SYSTEMS (K030795) | Gmp/Companies, Inc. | 2003-08-05 |
| PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101 (K023548) | Velocimed | 2003-08-04 |
| COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D (K014241) | Alsius Corp. | 2003-08-01 |
| TERUMO AL8X ARTERIAL FILTER WITH X-COATING (K032128) | Terumo Cardiovascular Systems Corp. | 2003-08-01 |
| IQ HYDROPHILIC GUIDE WIRE (K032183) | Boston Scientific Corp | 2003-08-01 |
| DBT, DYNAMIC BUBBLE TRAP (K031323) | Convergenza AG | 2003-08-01 |