| VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P (K043065) | Edwards Lifesciences, LLC | 2005-01-26 |
| CARDIOSTATION-100 (CS-100) (K041031) | Us Clover Co. | 2005-01-26 |
| MODIFICATION TO OUTBACK CATHETER (K043534) | Lumend, Inc. | 2005-01-21 |
| INFINITY GATEWAY SUITE, VF4 (K043549) | Draeger Medical Systems, Inc. | 2005-01-21 |
| MODIFICATION TO: RADIANALYZER, MODEL 12711 (K042628) | Radi Medical Systems AB | 2005-01-19 |
| VISTA PLUS (K042108) | Novacor | 2005-01-19 |
| OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400 (K043060) | Omron Healthcare, Inc. | 2005-01-19 |
| MASIMO SET RAD 57 PULSE CO-OXIMETER (K042536) | Masimo Corporation | 2005-01-19 |
| CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD) (K042849) | Cardiobiomedical Corporation | 2005-01-13 |
| PFA PATCH (K041736) | Peritec Biosciences, LLC | 2005-01-13 |
| ANEROID SPHYGMOMANOMETER, MODEL BK2002 (K043286) | Wenzhou Bokang Instrument Co.,Ltd | 2005-01-13 |
| PMP4 SELFCHECK ECG (K042254) | Card Guard Scientific Survival , Ltd. | 2005-01-13 |
| FLOWMEDIC, MODEL 220 (K042217) | Flowmedic (Israel), Ltd. | 2005-01-12 |
| FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET (K043437) | Health & Life Co., Ltd. | 2005-01-12 |
| ASAHI PTCA GUIDE WIRE, J SHAPE SERIES (K043422) | Asahi Intecc Co., Ltd. | 2005-01-12 |
| INBODY, MODEL 3.0 (K042528) | Biospace Corporation Limited | 2005-01-11 |
| MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701 (K043354) | Invivo Research, Inc. | 2005-01-10 |
| VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2 (K042657) | Vioptix, Inc. | 2005-01-10 |
| AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER (K042624) | Invatec Innovative Technologies, S.R.L. | 2005-01-10 |
| 4100 PATIENT OXIMETER MODULE (K043359) | Nonin Medical, Inc. | 2005-01-07 |
| PROXIS SYSTEM, MODEL EPS 101 (K042117) | Velocimed, Inc. | 2005-01-07 |
| CARDIOFAX CE, MODEL PEA-1110K (K042827) | Nihon Kohden America, Inc. | 2005-01-06 |
| READMYHEART (K042814) | Dailycare Biomedical, Inc. | 2005-01-06 |
| MODIFICATION TO PM-8000 PATIENT MONITOR (K043348) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005-01-06 |
| VANGUARD REPROCESSED PULSE OXIMETER SENSORS (K042316) | Vanguard Medical Concepts, Inc. | 2005-01-06 |
| VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES (K043552) | Vascutek, Ltd. | 2005-01-05 |
| DISPOSABLE NON-ADHESIVE SPO2 SENSORS (K042705) | Elekon Industries U.S.A., Inc. | 2004-12-29 |
| PMP4 OXY PRO (K043162) | Card Guard Scientific Survival , Ltd. | 2004-12-29 |
| CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508 (K042381) | Acumen Medical, Inc. | 2004-12-28 |
| TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9) (K040778) | Tanita Corp. of America | 2004-12-23 |
| DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE (K043276) | Datex-Ohmeda | 2004-12-23 |
| Lysus Infusion System (K043269) | Ekos Corp. | 2004-12-22 |
| 12-LEAD GLOVE (K033559) | Ineedmd | 2004-12-22 |
| CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE (K040592) | Cordis Corp. | 2004-12-17 |
| MODIFICATION TO SHORT INTRODUCER SHEATH (K042399) | Rex Medical, L.P. | 2004-12-17 |
| TORAYGUIDE GUIDEWIRE (K042370) | Toray Industries (America), Inc. | 2004-12-17 |
| SJM RIGID SADDLE RING MODEL RSAR-(SIZE) (K042734) | St. Jude Medical, Inc. | 2004-12-17 |
| VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5, VASCULAR IMAGER 5 AND INTEGRATED VASCULAR TOOLS (K033266) | Medical Imaging Applications, LLC | 2004-12-16 |
| OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR (K033973) | Nellcor Puritan Bennett, Inc. | 2004-12-13 |
| 6F Z4 GUIDE CATHETER (K042489) | Medtronic Vascular | 2004-12-13 |
| VITAL VISION ARTERIAL HARDNESS AND BLOOD PRESSURE MONITOR (K032825) | Mars Medical Products Co., Ltd. | 2004-12-10 |
| MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM (K042784) | Medrad, Inc. | 2004-12-10 |
| ACS MODEL NCP-2 (K042413) | Applied Cardiac Systems | 2004-12-09 |
| VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2 (K043103) | Edwards Lifesciences, LLC | 2004-12-09 |
| BIOZDX HEMODYNAMIC MONITOR (K041294) | Cardiodynamics International Corp. | 2004-12-08 |
| H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM (K043186) | Health & Life Co., Ltd. | 2004-12-06 |
| FLEXI-STAT SP02 EAR SENSOR (K042675) | Elekon Industries U.S.A., Inc. | 2004-12-06 |
| PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49 (K043023) | LeMaitre Vascular, Inc. | 2004-12-03 |
| HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES (K042148) | Ge Medical Syst. Information Technologies | 2004-12-03 |
| A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512 (K042967) | A&D Engineering, Inc. | 2004-12-03 |
| WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES (K041693) | Hangzhou Hua'An Medical & Health Instruments Co., | 2004-12-02 |
| OPTIV ANTAGE DH POWER INJECTION SYSTEM (K042744) | Mallinckrodt Inc., Liebel-Flarsheim Business | 2004-11-30 |
| ENPATH SAFETY INTRODUCER (K041708) | Enpath Medical Incorporated | 2004-11-30 |
| REUSABLE FINGER CLIP SPO2 SENSORS (K042704) | Elekon Industries U.S.A., Inc. | 2004-11-26 |
| GUIDEWIRES (K042264) | Rocket Medical Plc | 2004-11-24 |
| COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE (K042996) | Volcano Therapeutics, Inc. | 2004-11-24 |
| COMMANDER II (K043096) | Cardiocom | 2004-11-24 |
| VENTURE WIRE CONTROL CATHETER, MODEL WCC (K042910) | Velocimed, Inc. | 2004-11-22 |
| METRICATH SYSTEM (K042685) | Angiometrx, Inc. | 2004-11-18 |
| THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS (K042845) | Philips Medizin Systeme Boblingen GmbH | 2004-11-12 |
| NICOM (K042144) | Cheetah Medical, Inc. | 2004-11-12 |
| RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM (K042908) | Guidant Corp. | 2004-11-12 |
| LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE (K042611) | Cook, Inc. | 2004-11-12 |
| OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906 (K043018) | Omron Healthcare, Inc. | 2004-11-10 |
| FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888EA, HL888CF, HL888GF AND HL888QA (K042853) | Health & Life Co., Ltd. | 2004-11-10 |
| SUBMARINE PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SUVXXXXXXXXX (K042537) | Invatec Innovative Technologies | 2004-11-08 |
| SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SAEXXXXXXXXX (K042538) | Invatec Innovative Technologies | 2004-11-08 |
| POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM (K042230) | Cryo Vascular Systems, Inc. | 2004-11-05 |
| ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX) (K042874) | Possis Medical, Inc. | 2004-11-05 |
| T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303 (K040684) | Spectros Corporation | 2004-11-05 |
| INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER (K042775) | Irvine Biomedical, Inc. | 2004-11-04 |
| AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR) (K042642) | Ge Medical Systems Information Technologies | 2004-11-03 |
| C-BOOT (K041659) | C-Boot , Ltd. | 2004-10-28 |
| RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE (K042388) | Radiant Medical | 2004-10-28 |
| H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168H, HL168J & HL168Q (K042802) | Health & Life Co., Ltd. | 2004-10-26 |
| ACUMEN SHEATH, MODEL TTW7807 (K042376) | Acumen Medical, Inc. | 2004-10-26 |
| ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE (K042302) | Zoll Medical Corp | 2004-10-26 |
| VASOSTASIS VASCULAR CLOSURE SYSTEM (K041486) | Cardiva Medical, Inc. | 2004-10-22 |
| QRS-CARD CARDIOLOGY SUITE (K042799) | Pulse Biomedical, Inc. | 2004-10-22 |
| SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER (K042002) | Ela Medical, Inc. | 2004-10-20 |
| ERA 3000 PACING SYSTEM ANALYZER (K042708) | Biotronik, Inc. | 2004-10-20 |
| EXCELSIOR 1018 AND SL-10 MICROCATHETERS (K042568) | Boston Scientific Corp | 2004-10-15 |
| PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A (K042306) | Philips Medizin Systeme Boeblingen GmbH | 2004-10-15 |
| ACUSON ACUNAV 8F ULTRASOUND CATHETER (K042593) | Siemens Medical Solutions USA, Inc. | 2004-10-15 |
| ENSITE SYSTEM, MODEL EE3000 (K042493) | Endocardial Solutions, Inc. | 2004-10-15 |
| INTRAVASCULAR ACCESS INTRODUCER SHEATH (K041506) | Applied Medical Resources Corp. | 2004-10-15 |
| SILICONE COATED GUIDEWIRE (K041740) | Arrow International, Inc. | 2004-10-15 |
| 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000 (K041934) | 3M Company | 2004-10-15 |
| GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3 (K042771) | Datex-Ohmeda | 2004-10-15 |
| INTEGRATED PATIENT MONITORING SYSTEM (K041918) | Invivo Research, Inc. | 2004-10-15 |
| AMLUCK, YA HORNG (K042581) | Ya Horng Electronic Co., Ltd. | 2004-10-13 |
| BIOMEDIX PADNET LAB (K042616) | Biomedix, Inc. | 2004-10-12 |
| MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM (K042541) | Cryo Vascular Systems, Inc. | 2004-10-12 |
| ETG-4000 OPTICAL TOPOGRAPHY SYSTEM (K042501) | Hitachi Medical Corp. | 2004-10-12 |
| KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND LEG WARMER THERMAL BLANKET (K031728) | Klimamed Technologie Medizingerate GmbH | 2004-10-12 |
| BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER (K042469) | Braemar, Inc. | 2004-10-06 |
| STELLAR 404 MONITORING SYSTEM (K042560) | Larsen & Toubro Limited | 2004-10-06 |
| CARDEON COBRA CATHETER (K042156) | Cardeon Corp. | 2004-10-06 |
| EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE (K042060) | Millimed A/S | 2004-10-06 |
| MPM SYSTEM (K041854) | Aerotel Medical Systems, Ltd. | 2004-10-06 |