| SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE (K050339) | Laboratorios Grifols, S.A. | 2005-02-25 |
| VORTEX EZ VASCULAR ACCESS PORT (K050176) | Rita Medical Systems, Inc. | 2005-02-25 |
| THERMAL CAUTERY PROBE (K050308) | Starion Instruments | 2005-02-25 |
| MOMENTS MENOPAUSE CHECK, MODEL 9113 (K043599) | Phamatech, Inc. | 2005-02-25 |
| BEAMCATH (K042110) | Beampoint AB | 2005-02-25 |
| ENDOASSIST (K043284) | Armstrong Healthcare Limited | 2005-02-25 |
| VIVAWAVE MICROWAVE ABLATION SYSTEM, COAXIAL INTRODUCER (K050223) | Vivant Medical, Inc. | 2005-02-24 |
| EPIPHYSIS SCREW (K043410) | I.T.S. Implantat-Technologie-Systeme GmbH | 2005-02-24 |
| BIS SRS (SEMI-RESUABLE SENSOR) (K050313) | Aspect Medical Systems, Inc. | 2005-02-24 |
| ELLIPSE LIGHT SPT (K043255) | Danish Dermatologic Development A/S | 2005-02-24 |
| KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0 (K043104) | Practiceworks, Inc. | 2005-02-24 |
| HRK-123 KNEE ARRAY COIL (K050299) | Mri Devices Corporation | 2005-02-24 |
| BURANE XL (K050317) | Wavelight Laser Technologie AG | 2005-02-24 |
| SECTRA IDS5 WORKSTATION (K050196) | Sectra Imtec AB | 2005-02-24 |
| BIOFLEX LD-175 AND LD-1200 TREATMENT HEADS (K041885) | Meditech International, Inc. | 2005-02-24 |
| DERMILLUME, MODEL PRO1000 (K043575) | Care Electronics, Inc. | 2005-02-24 |
| SILIMED PECTORAL IMPLANT (K042054) | Silimed, Inc. | 2005-02-23 |
| PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM (K050386) | Dentsply International | 2005-02-23 |
| QUADRANT RETRACTOR SYSTEM (K043602) | Medtronic Sofamor Danek | 2005-02-23 |
| XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A (K050380) | Toshiba America Medical Systems, In.C | 2005-02-23 |
| DUREX PLAY WARMER LUBRICANT (K042563) | Ssl Americas, Inc. | 2005-02-23 |
| MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM (K043297) | Medicon EG | 2005-02-23 |
| WELLNESS/JOLIVETE (K040905) | Tohkai Precision Ind. , Ltd. | 2005-02-23 |
| PSD-60/ENDOPLASMA (K042274) | Olympus Shirakawa Co., Ltd. | 2005-02-22 |
| DUOPROSS SYRINGES (K042500) | Duopross Meditech Corporation | 2005-02-22 |
| 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 |
| FERRIS POLYMEM STERILE BREAST PAD (K031660) | Ferris Mfg. Corp. | 2005-02-22 |
| MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE (K050191) | Becton, Dickinson & CO | 2005-02-22 |
| COMPATIBILITY ECG TRUNK CABLES (K043572) | Datex-Ohmeda | 2005-02-22 |
| SMITH & NEPHEW, INC. REVISION KNEE SYSTEM (K043440) | Smith & Nephew, Inc. | 2005-02-18 |
| MODIFICATION TO TSRH SPINAL SYSTEM (K050282) | Medtronic Sofamor Danek | 2005-02-18 |
| INION OTPS BIODEGRADABLE MINI PLATING SYSTEM (K043142) | Inion , Ltd. | 2005-02-18 |
| INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C (K042984) | Intervascular | 2005-02-18 |
| BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B (K043145) | Arthrex, Inc. | 2005-02-18 |
| BLAKSTONE LAMINOPLASTY FIXATION SYSTEM (K043338) | Blackstone Medical, Inc. | 2005-02-18 |
| WELL LEAD ENDOTRACHEAL TUBE (K042683) | Well Lead Medical Instruments | 2005-02-18 |
| PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE (K043490) | Vidacare Corporation | 2005-02-18 |
| TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO (K043160) | Tracoe Medical GmbH | 2005-02-18 |
| SECURELOC; ADVANCINTRODUCER (K050023) | Specialized Health Products, Inc. | 2005-02-18 |
| MAGNETOM SYMPHONY A TIM SYSTEM (K050199) | Siemens Medical Solution | 2005-02-18 |
| INFINITY KAPPA XLT (K042904) | Draeger Medical Systems, Inc. | 2005-02-18 |
| D-STAT RADIAL HEMOSTATIC BAND (K050133) | Vascular Solutions, Inc. | 2005-02-18 |
| ROC LUMBAR PLATING SYSTEM (K050078) | Alphatec/Nexmed | 2005-02-18 |
| SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300 (K043553) | Fox Hollow Technologies | 2005-02-18 |
| GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL (K043054) | Sultan Chemists, Inc. | 2005-02-18 |
| 4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N (K043351) | Triage Medical, Inc. | 2005-02-18 |
| PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES (K050187) | Sofradim Production | 2005-02-18 |
| STANSION MATRIX (K042600) | Spineworks, LLC | 2005-02-18 |
| INTERGRO DBM (K031399) | Interpore Cross Intl. | 2005-02-18 |
| LERADO, COSCO (K050290) | Lerado Oversea Ltd. Twn Branch (Bvi) | 2005-02-18 |
| VITEK 2 GRAM POSITIVE ERTAPENEM (K050076) | bioMerieux, Inc. | 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 |
| AQUINOX (K050314) | Smiths Medical Asd, Inc. | 2005-02-18 |
| AGFA HEARTLAB CARDIOVASCULAR (K050228) | Heartlab, 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 |
| SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200 (K043379) | Shimadzu Corp. | 2005-02-17 |
| MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML) (K043545) | Dade Behring, Inc. | 2005-02-17 |
| MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM (K050117) | Medtronic Sofamor Danek | 2005-02-17 |
| BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS (K043100) | Biomet, Inc. | 2005-02-17 |
| RESOFIX BIOABSORBABLE EXPANSION BOLT (K043411) | Resofix, Inc. | 2005-02-17 |
| DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT (K042957) | Ssl Americas | 2005-02-17 |
| VITEK 2 COMPACT (K050002) | bioMerieux, Inc. | 2005-02-17 |
| SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH CATHETER, 6 FR., MODEL S00019 (K042308) | Facile Medical, Inc. | 2005-02-17 |
| MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM (K042928) | U&I Corp. | 2005-02-17 |
| FUKUDA DENSHI MODEL UF-850XTD (K050363) | Fukuda Denshi USA, Inc. | 2005-02-17 |
| WELL LEAD TRACHEOSTOMY TUBE (K042684) | Well Lead Medical Instruments | 2005-02-17 |
| BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER (K042553) | Biocardia, Inc. | 2005-02-17 |
| VARIAN NASOPHARYNX APPLICATOR (K042360) | Varian Medical Systems, Inc. | 2005-02-16 |
| DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATING (K043374) | Howmedica Osteonics Corp. | 2005-02-16 |
| OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC (K043421) | Regeneration Technologies, Inc. | 2005-02-16 |
| GAMMA3 NAIL SYSTEM (K043431) | Howmedica Osteonics Corp. | 2005-02-16 |
| SPACELINE EMCIA, MODEL CU580 (K043496) | J. Morita USA, Inc. | 2005-02-16 |
| EBI TROCHANTERIC NAIL SYSTEM (K050118) | Ebi, L.P. | 2005-02-16 |
| MODIFICATION TO: HEALOS BONE GRAFT MATERIAL (K043308) | Depuy Spine, Inc. | 2005-02-16 |
| TECHTONIX SYSTEM (K050189) | Stryker Spine | 2005-02-16 |
| XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM (K050103) | Abbott Laboratories | 2005-02-16 |
| TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE (K043498) | J. Morita USA, Inc. | 2005-02-16 |
| SURGICAL FACE MASK (K043199) | Hong YA Non-Woven Products Co., Ltd. | 2005-02-16 |
| PERSONAL INJECTOR (K033696) | Union Medico Aps | 2005-02-16 |
| VASCON POLARIS GUIDING CATHETER (K043387) | Vascon, LLC | 2005-02-16 |
| APEX MEDICAL MININEB & MINIPLUS (K050104) | Apex Medical Corp. | 2005-02-16 |
| TURBO TEMP TRIO (K050230) | Cardinal Health, Alaris Products | 2005-02-16 |
| TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS (K043248) | Arthrex, Inc. | 2005-02-16 |
| PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240 (K040958) | Tokyo Boeki Medical System , Ltd. | 2005-02-15 |
| SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS (K050077) | Arkray, Inc. | 2005-02-15 |
| NEURO II-S (K050132) | Innovative Magnetic Resonance Imaging Systems, Inc. | 2005-02-15 |
| WAVELIGHT SINON (K050218) | Wavelight Laser Technologie AG | 2005-02-15 |
| N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) (K042735) | Dade Behring, Inc. | 2005-02-15 |
| STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT (K043476) | Dade Behring, Inc. | 2005-02-15 |
| MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM (K050240) | Siemens Medical Solutions USA, Inc. | 2005-02-15 |
| SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2 (K043268) | Randox Laboratories, Ltd. | 2005-02-15 |
| 8NONE (K041839) | Medical Solutions, Inc. | 2005-02-15 |
| ACHIEVA FAMILY (K043147) | Philips Medical Systems North America Co. | 2005-02-15 |
| PLANET 50 MONITORING SYSTEM (K043370) | Larsen & Toubro Limited | 2005-02-15 |
| RANDOX URINE CONTROLS (K043266) | Randox Laboratories, Ltd. | 2005-02-15 |
| DAKOCYTOMATION ER/PR PHARMDX KIT (K042884) | Dakocytomation California, Inc. | 2005-02-15 |
| LARGE BORE SPLITTABLE INTRODUCER KIT (K043438) | Thomas Medical Products, Inc. | 2005-02-15 |