| INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5 (K042656) | Draeger Medical Systems, Inc. | 2004-10-06 |
| ZOLL M SERIES ETC02 LOFLO OPTION (K042417) | Zoll Medical Corp | 2004-10-05 |
| 8600 VITAL SIGNS MONITOR (K042569) | Criticare Systems, Inc. | 2004-09-29 |
| STOCKERT SCP RHYTHM (K042374) | Stockert Instrumente GmbH | 2004-09-23 |
| Lysus Infusion System (K042456) | Ekos Corp. | 2004-09-23 |
| MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS (K041127) | Sterilmed, Inc. | 2004-09-23 |
| VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP) (K041909) | Vascular Solutions, Inc. | 2004-09-23 |
| CLIPPER DIAGNOSTIC ELECTRODE CATHETER (K042105) | Bard Electrophysiology | 2004-09-23 |
| MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M (K040915) | Invivo Research, Inc. | 2004-09-22 |
| AMBU DISPOSABLE ECG ELECTRODE (K041734) | Ambu, Inc. | 2004-09-22 |
| HOLTER PLUS (K042463) | Rozinn Electronics, Inc. | 2004-09-22 |
| LNCS OXIMETRY SENSORS (K042346) | Masimo Corporation | 2004-09-20 |
| ZEWA MFM-007 BLOOD PRESSURE MONITOR (K041491) | Zewa, Inc. | 2004-09-20 |
| PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A (K040904) | Philips Medical Systems | 2004-09-16 |
| CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE (K042338) | Lake Region Mfg., Inc. | 2004-09-16 |
| SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA) (K042020) | Hutchinson Technology, Inc. | 2004-09-15 |
| DISPOSABLE MONITORING ELECTRODES (K041954) | Shanghai Intco Electrode Manufacturing Co., Ltd. | 2004-09-15 |
| ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY (K042194) | Medtronic Vascular | 2004-09-15 |
| VST3 (K040942) | Biowatch Medical, Inc. | 2004-09-15 |
| MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADHESIVE SENSORS AND ADHESIVE SPO2 SENSORS (K041964) | Mediaid, Inc. | 2004-09-14 |
| FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS (K041522) | Elekon Industries U.S.A., Inc. | 2004-09-14 |
| PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20 (K040479) | Welch Allyn, Inc. | 2004-09-14 |
| MODIFICATION TO EPTFE GRAFT (K041528) | Vascutek, Ltd. | 2004-09-14 |
| ZOE FLUID STATUS MONITOR (K042113) | Noninvasive Medical Technologies, LLC | 2004-09-14 |
| EP-4 CLINICAL STIMUTATOR (K041442) | Ep Medsystems | 2004-09-14 |
| PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE (K040178) | S.P.O. Medical Equipment, Ltd. | 2004-09-10 |
| HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N (K041867) | Hygia Health Services, Inc. | 2004-09-10 |
| MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC) (K042128) | Zargis Medical Corp. | 2004-09-08 |
| X-SIZER CATHETER SYSTEM (K021096) | Ev3 Corporation | 2004-09-08 |
| SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21 (K041883) | Leonhard Lang GmbH | 2004-09-07 |
| MODEL 6416 TEMPORARY PACING LEAD SYSTEM (K042190) | Medtronic Vascular | 2004-09-07 |
| ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90 (K042187) | Micro Therapeutics, Inc. | 2004-09-02 |
| MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260 (K041979) | Quest Medical, Inc. | 2004-09-02 |
| DETECT SURGICAL PACING AND MAPPING TOOL (K040812) | Medtronic Vascular | 2004-09-02 |
| SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301 (K042088) | Heartsine Technologies, Inc. | 2004-09-02 |
| DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 (K040831) | Datex-Ohmeda, Inc. | 2004-09-02 |
| FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE) (K041647) | Elekon Industries U.S.A., Inc. | 2004-09-02 |
| RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2 (K041705) | Omnisonics Medical Technologies | 2004-09-01 |
| ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM (K042218) | Guidant Corp. | 2004-08-31 |
| FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR MODEL# HL888 (K042265) | Health & Life Co., Ltd. | 2004-08-31 |
| LIFECLINIC, MODEL 2400 (K040562) | Lifeclinic International, Inc. | 2004-08-31 |
| REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T (K041778) | Maxi-Aids, Inc. | 2004-08-31 |
| SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER (K041901) | North East Monitoring, Inc. | 2004-08-31 |
| MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY (K042273) | Health Hero Network, Inc. | 2004-08-31 |
| PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200 (K032831) | Conmed Corporation | 2004-08-31 |
| DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420 (K040380) | Dolphin Medical, Inc. | 2004-08-31 |
| MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM (K042177) | Ge Medical Systems Information Technologies | 2004-08-27 |
| RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG01703 (K041123) | Kerberos Proximal Solutions, Inc. | 2004-08-26 |
| TIDAL WAVE SP MODEL 710/715 AND 715 (K032971) | Respironics Novametrix, Inc. | 2004-08-26 |
| PIESOMETER, MODEL MK-1 (K041169) | Canamet Canadian Natl Medical Technologies, Inc. | 2004-08-24 |
| FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311 (K042138) | Sein Electronics Co., Ltd. | 2004-08-24 |
| MONITORING SYSTEM, MODEL ARGUS PB-2200 (K033738) | Schiller AG | 2004-08-24 |
| FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-01 (K041400) | Fortifier International Co., Ltd. | 2004-08-24 |
| AIRGUARD VALVED INTRODUCER (K042036) | C.R. Bard, Inc. | 2004-08-23 |
| SPOT CHECK PULSE OXIMETER,512/513 (K032949) | Respironics Novametrix, Inc. | 2004-08-23 |
| WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE (K040490) | Welch Allyn, Inc. | 2004-08-18 |
| VENTURE WIRE CONTROL CATHETER (K040922) | Velocimed, Inc. | 2004-08-18 |
| HOMMED GENESIS PATIENT MONITOR SYSTEM WITH OPTIONS (K040799) | Hommed, LLC | 2004-08-18 |
| MICRO PRIME (K041650) | Innovx Medical, Inc. | 2004-08-16 |
| MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM (K041973) | Intra Luminal Therapeutics, Inc. | 2004-08-16 |
| 2 CM PERIPHERAL CUTTING BALOON (K041993) | Boston Scientific Ivt | 2004-08-16 |
| E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDER (K042022) | Datrix, Inc. Dba of Jon Barron, Inc. | 2004-08-12 |
| TERUMO CIRCUIT CONNECTORS (K041697) | Terumo Cardiovascular Systems Corporation | 2004-08-11 |
| MODIFIED CONCENTRIC RETRIEVER, MODEL 90038 (K040745) | Concentric Medical, Inc. | 2004-08-11 |
| MERCI RETRIEVER, MODELS 90065, 90066 (K033736) | Concentric Medical, Inc. | 2004-08-11 |
| HOMMED SENTRY IIIB-F PATIENT MONITOR SYSTEM (K040651) | Hommed, LLC | 2004-08-10 |
| POLYURETHANE BLOOD PRESSURE CUFFS (K041689) | D. E. Hokanson, Inc. | 2004-08-06 |
| FINISHING WIRE SUPPORTRAK (K041762) | Guidant Corporation | 2004-08-06 |
| FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH (K032884) | Boston Scientific Epi | 2004-08-06 |
| PERMANENT PACING LEAD, MODEL PY2 (K041809) | Oscor, Inc. | 2004-08-06 |
| POWERHEART AED G3 PRO (K040637) | Cardiac Science, Inc. | 2004-08-06 |
| DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400 (K042014) | Sein Electronics Co., Ltd. | 2004-08-06 |
| C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS (K041434) | Analogic Corp. | 2004-08-06 |
| LYSUS INFUSION SYSTEM (K041629) | Ekos Corp. | 2004-08-06 |
| INFUSIONCATH (K041517) | Id, LLC | 2004-08-05 |
| NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000 (K033685) | Medical Cv, Inc. | 2004-08-03 |
| ASAHI PTCA GUIDE WIRE CONFIANZA PRO (K041531) | Asahi Intecc Co., Ltd. | 2004-08-03 |
| FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE) (K041644) | Elekon Industries U.S.A., Inc. | 2004-07-29 |
| LNCS OXIMETRY SENSORS (K041815) | Masimo Corp. | 2004-07-29 |
| EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE (K033463) | Edwards Lifesciences, LLC | 2004-07-28 |
| DATEX-OHMEDA PRESTN.01 MODULE (MODEL FAMILY M-PRESTN.01) AND ACCESSORIES (K041772) | Datex-Ohmeda | 2004-07-28 |
| DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE (K041790) | Datex-Ohmeda | 2004-07-23 |
| TRIO MONITOR (K041907) | Datascope Corp. | 2004-07-23 |
| MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 (K041727) | Boston Scientific Scimed, Inc. | 2004-07-23 |
| M2376A DEVICELINK SYSTEM (K041942) | Phillips Medical Systems | 2004-07-23 |
| SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023 (K041453) | Smith & Nephew, Inc. | 2004-07-22 |
| PTFE FELTS AND PLEDGETS (K041716) | Boston Scientific Corp | 2004-07-22 |
| TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE (K040978) | Tanita Corp. of America | 2004-07-22 |
| KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIES (K041151) | Kerberos Proximal Solutions, Inc. | 2004-07-22 |
| M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN (K041741) | Philips Medical Systems, Inc. | 2004-07-21 |
| MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-AP (K041411) | Microlife Corp. | 2004-07-21 |
| C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A (K041376) | Analogic Corp. | 2004-07-20 |
| RTX3320PSTN WIRELESS TELEHEALTH GATEWAY (K041816) | Rtx Healthcare A/S | 2004-07-19 |
| MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES (K041338) | Medtronic Vascular | 2004-07-19 |
| GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS (K040010) | Genesis Medical Interventional, Inc. | 2004-07-19 |
| THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT (K041674) | Philips Medical Systems | 2004-07-19 |
| PTCA STEERABLE HYDROPHILIC GUIDEWIRE (K041624) | Lake Region Mfg., Inc. | 2004-07-16 |
| QUINTON Q-TE; RMS (K041607) | Quinton Cardiology, Inc. | 2004-07-16 |
| NONINVASIVE BLOOD PRESSURE MONITOR, MODELS MD-880B AND MD-900T (K041789) | Meditec Co., Ltd. | 2004-07-15 |
| KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE (K040649) | Tyco Healthcare | 2004-07-15 |