| FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168GA, HL168GS (K050714) | Health & Life Co., Ltd. | 2005-04-07 |
| ZOLL E SERIES DEFIBRILLATOR (K042007) | Zoll Medical Corp | 2005-04-07 |
| HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM (K050225) | Cambridge Heart, Inc. | 2005-04-07 |
| OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N (K042505) | Omron Healthcare, Inc. | 2005-04-05 |
| FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KM, HL888DM (K050587) | Health & Life Co., Ltd. | 2005-04-05 |
| M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE G.00 (K050742) | Philips Medical Systems | 2005-04-05 |
| MUSE CARDIOLOGY INFORMATION SYSTEM (K050614) | Ge Medical Systems Information Technologies | 2005-04-05 |
| OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M (K042506) | Omron Healthcare, Inc. | 2005-04-05 |
| HEALTH BUDDY APPLIANCE (K050567) | Health Hero Network, Inc. | 2005-04-05 |
| HL 200 ELECTRONIC STETHOSCOPE (K050169) | Health & Life Co., Ltd. | 2005-04-05 |
| CORDIS AMIIA .014 PTA BALLOON CATHETER (K050645) | Cordis Corp. | 2005-04-01 |
| CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 (K050172) | Cardiomedics, Inc. | 2005-03-31 |
| H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KA, HL888LF & HL888IF (K050491) | Health & Life Co., Ltd. | 2005-03-31 |
| GOCANNING GLS-700 E-PULSE ANALYSIS MONITOR (K043352) | Gocanning Technology , Ltd. | 2005-03-31 |
| ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014 (K050577) | Boston Scientific Corp | 2005-03-30 |
| MS-753 MARS INFLATE-READ BLOOD PRESSURE MONITOR (K050040) | Mars Medical Products | 2005-03-30 |
| SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS (K050670) | Tms Telemedizinische Systeme GmbH | 2005-03-30 |
| HL168JP (K050249) | Health & Life Co., Ltd. | 2005-03-30 |
| FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING) (K050217) | Biosense Webster, Inc. | 2005-03-30 |
| EKOS PERIPHERAL INFUSION SYSTEM (K050563) | Ekos Corp. | 2005-03-29 |
| MS-930 MARS INFLATE-READ BLOOD PRESSURE MONITOR (K050039) | Mars Medical Products | 2005-03-25 |
| REPROCESSED ELECTROPHYSIOLOGY CATHETERS (K043392) | Alliance Medical Corp. | 2005-03-25 |
| MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR (K050697) | Nihon Seimitsu Sokki Co., Ltd. | 2005-03-25 |
| ALLIGATOR RETRIEVAL DEVICE (ARD) (K043580) | Chestnut Medical Technologies, Inc. | 2005-03-24 |
| CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 (K043454) | Medicomp, Inc. | 2005-03-24 |
| REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS (K043393) | Alliance Medical Corp. | 2005-03-23 |
| TRIACTIV SYSTEM (K042040) | Kensey Nash Corp. | 2005-03-23 |
| 12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200 (K050074) | Welch Allyn, Inc. | 2005-03-22 |
| GS-128 GRADIENT COMPRESSION SYSTEM (K050584) | Medmark Technologies, LLC | 2005-03-22 |
| ACCUHEART ELECTRODE BELT (K043361) | Advanced Bioelectric Corporation | 2005-03-22 |
| PIVOT STEERABLE MICROCATHETER (K050630) | Boston Scientific - Precision Vascular | 2005-03-22 |
| MODIFICATION TO: EXPORT CATHETER (K050139) | Medtronic Vascular | 2005-03-22 |
| KD-575 MEMORY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K042418) | Kodon(Tianjin)Electronic&Electrical Apparatus Co., | 2005-03-21 |
| CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8 (K042999) | Biosense Webster, Inc. | 2005-03-21 |
| V-BAG WITH GBS COATING (K050195) | Gish Biomedical, Inc. | 2005-03-17 |
| REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER (K033436) | Alliance Medical Corp. | 2005-03-16 |
| SPECTRANETICS LLD CS, MODEL 518-039 (K043401) | Spectranetics Corp. | 2005-03-16 |
| LYSUS INFUSION SYSTEM (K050472) | Ekos Corp. | 2005-03-11 |
| VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K040751) | Vanguard Medical Concepts, Inc. | 2005-03-10 |
| HYPERQ SYSTEM (K042981) | Biological Signal Processing, Ltd. | 2005-03-10 |
| DIASYS INTEGRA II (K042109) | Novacor France | 2005-03-09 |
| VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K042074) | Vanguard Medical Concepts, Inc. | 2005-03-09 |
| SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG (K050111) | Cobe Cardiovascular, Inc. | 2005-03-08 |
| PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR (K050447) | Dideco S.R.L. | 2005-03-08 |
| DIVER C.E. CATHETER (K050276) | Invatec Innovative Technologies, S.R.L. | 2005-03-07 |
| BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH (K050205) | Flowmedica, Inc. | 2005-03-04 |
| SPACELABS MEDICAL MULTIPARAMETER MODULE 91496 (K050175) | Spacelabs Medical, Inc. | 2005-03-04 |
| AMPLIEF WRIST BLOOD PRESSURE MONITOR, MODEL M600 (K050413) | Amplife Corporation | 2005-03-04 |
| A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR (K043217) | A&D Engineering, Inc. | 2005-03-03 |
| AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060 (K041374) | Idev Technologies, Inc. | 2005-03-02 |
| GALEO FOCUS GUIDE WIRE (K042373) | Biotronik, Inc. | 2005-03-02 |
| STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER (K043513) | Sterilmed, Inc. | 2005-03-01 |
| STERILEMED REPROCESSED IVUS IMAGING CATHETER (K043453) | Sterilmed, Inc. | 2005-03-01 |
| MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE (K043398) | Neometrics, Inc. | 2005-03-01 |
| TRIFIT 700 (K033646) | Healthfirst Corp. | 2005-03-01 |
| MODIFICATION TO ENDOVASCULAR GUIDE WIRE (K043457) | Stereotaxis, Inc. | 2005-02-28 |
| HOLTER RECORDER H3+ (K043010) | Mortara Instrument, Inc. | 2005-02-25 |
| PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304 (K050004) | Philips Medical Systems | 2005-02-25 |
| LIBERTY SYSTEM (K043074) | Inovise Medical, Inc. | 2005-02-22 |
| MULTIPLE, MODEL KTJ-50 (K043444) | Golden Horse Medical Equipment (Wuxi) Co. , Ltd. | 2005-02-22 |
| MEDICOMPASS CONNECT (K042768) | Imetrikus, Inc. | 2005-02-22 |
| MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000 (K050159) | 3M Company | 2005-02-22 |
| COMPATIBILITY ECG TRUNK CABLES (K043572) | Datex-Ohmeda | 2005-02-22 |
| INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C (K042984) | Intervascular | 2005-02-18 |
| SECURELOC; ADVANCINTRODUCER (K050023) | Specialized Health Products, Inc. | 2005-02-18 |
| INFINITY KAPPA XLT (K042904) | Draeger Medical Systems, Inc. | 2005-02-18 |
| SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300 (K043553) | Fox Hollow Technologies | 2005-02-18 |
| INFINITY MODULAR MONITORS WITH VF5 MODIFICATIONS (DELTA/KAPPA/DELTA XL/VISTA XL/GAMMA X XL AND SC 7000/8000/9000XL (K043439) | Draeger Medical Systems, Inc. | 2005-02-18 |
| DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND ACCESSORIES (K043551) | Datex-Ohmeda | 2005-02-18 |
| SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH CATHETER, 6 FR., MODEL S00019 (K042308) | Facile Medical, Inc. | 2005-02-17 |
| BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER (K042553) | Biocardia, Inc. | 2005-02-17 |
| VASCON POLARIS GUIDING CATHETER (K043387) | Vascon, LLC | 2005-02-16 |
| PLANET 50 MONITORING SYSTEM (K043370) | Larsen & Toubro Limited | 2005-02-15 |
| LARGE BORE SPLITTABLE INTRODUCER KIT (K043438) | Thomas Medical Products, Inc. | 2005-02-15 |
| MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER (K050073) | Invatec Innovative Technologies, S.R.L. | 2005-02-11 |
| THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS (K050141) | Philips Medizin Systeme Boeblingen GmbH | 2005-02-11 |
| ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS (K043463) | Envitec-Wismar GmbH | 2005-02-11 |
| TRILLIUM BIOPUMP PLUS, MODEL BPX80T (K050109) | Medtronic Perfusion Systems | 2005-02-11 |
| CATHETER INTRODUCER (K043525) | Galt Medical Corp. | 2005-02-09 |
| HL 188 & HL 189 BODY FAT METER (K043414) | Health & Life Co., Ltd. | 2005-02-09 |
| LNOPV AD-L AND PD-L OXIMETRY SENSORS (K050068) | Masimo Corporation | 2005-02-09 |
| SELECT 3D ARTERIAL CANNULA (K043179) | Medtronic Perfusion Systems | 2005-02-08 |
| QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER (K050088) | Neoprobe Corp. | 2005-02-08 |
| STEREOTAXIS ENDOVASCULAR GUIDE WIRE (K042854) | Stereotaxis, Inc. | 2005-02-08 |
| ZOLL AED PRO EXTERNAL DEFIBRILLATOR (K041892) | ZOLL Medical Corporation | 2005-02-04 |
| REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM (K043257) | Ep Technologies, Inc. | 2005-02-03 |
| TRANSMITTER, ZS-940PA SERIES (K043517) | Nihon Kohden America, Inc. | 2005-02-03 |
| MODIFIED ACUMEN SHEATH, MODEL TTWO767 (K050015) | Acumen Medical, Inc. | 2005-02-03 |
| TRELLIS-8 PERIPHERAL INFUSION SYSTEM (K050147) | Bacchus Vascular, Inc. | 2005-02-03 |
| BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER (K043371) | Biomerix Corporation | 2005-02-03 |
| D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR (K043323) | Dideco S.R.L. | 2005-02-01 |
| MODEL SC-3008 SEQUENTIAL CIRCULATOR (K043423) | Bio Compression Systems, Inc. | 2005-02-01 |
| VITELCARE TURTLE, MODEL 400 (K043368) | Visual Telecommunications Network, Inc. | 2005-02-01 |
| MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER (K042937) | Vascular Solutions, Inc. | 2005-01-31 |
| DYNAFLO BYPASS GRAFT (K050049) | Bard Peripheral Vascular, Inc. | 2005-01-31 |
| ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS (K041630) | Cardiovascular Systems Incorporated | 2005-01-31 |
| HORIZON ANGIO CATHLAB (K043564) | Mennen Medical , Ltd. | 2005-01-27 |
| PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW3003 AND EW3037 (K042818) | Matsushita Electric Works, Ltd. | 2005-01-27 |
| AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304 (K042623) | St. Jude Medical, Daig Division, Inc. | 2005-01-27 |
| AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100 (K043550) | Amplife Corporation | 2005-01-27 |