| MERETE DUOTHREADTM BONE SCREW (K050924) | Merete Medical GmbH | 2005-05-27 |
| MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE (K042606) | Synthes (Usa) | 2005-05-27 |
| PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT) (K051067) | LeMaitre Vascular, Inc. | 2005-05-27 |
| PROCON2 (K042431) | Incontinent Control Devices, Inc. | 2005-05-27 |
| FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES (K050065) | Ciba Vision Corporation | 2005-05-27 |
| MICROPUMP MP-101 (K051252) | Micrel Medical Devices S.A. | 2005-05-27 |
| RESO-PAC PERIODONTAL DRESSING (K050658) | Hager Worldwide, Inc. | 2005-05-27 |
| SPSMEDICAL SPORVIEW PLUS STEAM BI TEST PACK (K051173) | Spsmedical Supply Corp. | 2005-05-27 |
| ARTHREX BIO-PIN (K050259) | Arthrex, Inc. | 2005-05-27 |
| POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR (K043342) | Gambro Renal Products | 2005-05-27 |
| BALANCE HIP SYSTEM (K050251) | Biomet, Inc. | 2005-05-27 |
| VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY (K050146) | Vascular Solutions, Inc. | 2005-05-27 |
| ENCORE REVERSE SHOULDER PROSTHESIS (K051075) | Encore Medical L.P. | 2005-05-27 |
| FORMAGRAFT COLLAGEN BONE GRAFT MATRIX (K050789) | R and D Medical, LLC | 2005-05-27 |
| PEEK CAS (K050861) | Interpore Cross Intl. | 2005-05-27 |
| MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS) (K033262) | Gambro Renal Products | 2005-05-27 |
| INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059 (K051341) | Inion , Ltd. | 2005-05-27 |
| PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT (K050166) | Smiths Medical | 2005-05-26 |
| CANALIZER HYDROPHILIC GUIDE WIRE (K050873) | Medical Device Technologies, Inc. | 2005-05-26 |
| ULTRASONIC BIO-MICROSCOPE, MODEL P60 (K050980) | Paradigm Medical Industries, Inc. | 2005-05-26 |
| ANGIODYNAMICS PROFILER PTA BALLOON CATHETER (K051060) | AngioDynamics, Inc. | 2005-05-26 |
| ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY (K050632) | Bayer Healthcare, LLC | 2005-05-26 |
| E1 MEDICAL FLAT PANEL DISPLAY SYSTEM AND MFGD 1218 MEDICAL FLAT PANEL DISPLAY (K051201) | Barcoview | 2005-05-26 |
| ACCENT (K050693) | Air Techniques, Inc. | 2005-05-26 |
| JEIL BONE FIXATION SYSTEM (K050669) | Jeil Medical Corporation | 2005-05-26 |
| EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM (K050766) | Zimmer Trabecular | 2005-05-26 |
| ZIEHM QUANTUM (K051064) | Ziehm Imaging, Inc. | 2005-05-26 |
| V.A.C. GRANUFOAM SILVER PROTECTION DRESSING (K050261) | Kinetic Concepts, Inc. | 2005-05-26 |
| POWERHOHN AND POWERLINE CATHETERS (K050185) | C.R. Bard, Inc. | 2005-05-26 |
| RAYCELL X-RAY BLOOD IRRADIATOR (K051065) | Mds Nordion | 2005-05-26 |
| DDRCOMBI TRAUMA (K050718) | Swissray International, Inc. | 2005-05-26 |
| XPAND CORPECTOMY SPACER (K050850) | Globus Medical, Inc. | 2005-05-26 |
| U-BALLOON DILATION CATHETER (K050875) | C.R. Bard, Inc. | 2005-05-26 |
| MMS VIDEO OPTION (K050993) | Medical Measurement Systems B.V. | 2005-05-26 |
| B-CAD SYSTEM, VERSION 1.0 (K050846) | The Medipattern Corporation | 2005-05-26 |
| ULTRA-SOFT SV BALLOON DILATATION CATHETER (K050389) | Boston Scientific Corp | 2005-05-25 |
| LIGHT DRAPE (K043234) | Wrapped IN Comfort | 2005-05-25 |
| ELECTRODE (K050248) | Electramold | 2005-05-25 |
| CPAP HUMIDIFIER, MODEL HC238JHU (K050904) | Fisher & Paykel Healthcare, Ltd. | 2005-05-25 |
| DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC (K051092) | GE Healthcare | 2005-05-25 |
| ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE (K043249) | Atrion Medical Products, Inc. | 2005-05-25 |
| FIRSTLINE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE-STEEL BLUE COLOR) (K043149) | Firstline, LLC | 2005-05-25 |
| BLUELEX (K051203) | Monitex Industrial Co., Ltd. | 2005-05-25 |
| SMITH & NEPHEW VULCAN ARTICULAR CARTILAGE PROBE, MODEL 721XXXX (K050898) | Smith & Nephew, Inc. | 2005-05-25 |
| SALUTE FIXATION SYSTEM (K050610) | Davol Inc., Sub. C. R. Bard, Inc. | 2005-05-25 |
| NAVIPRO SHOULDER SOFTWARE MODULE (K050897) | Kinamed, Inc. | 2005-05-24 |
| HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR (K051040) | Medtronic Perfusion Systems | 2005-05-24 |
| BD PHONIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTAXIME STREP (0.0625-4UG/ML) (K050982) | Becton, Dickinson & CO | 2005-05-24 |
| INTRABEAM SYSTEM (K051055) | Carl Zeiss Surgical GmbH | 2005-05-23 |
| DDAT OMT (K050098) | Ddat(Uk), Ltd. | 2005-05-23 |
| MC6A (K050735) | Macan Engineering Co. | 2005-05-23 |
| CUSTOM-HIP TOOL (K051181) | Orthopedic Sciences, Inc. | 2005-05-23 |
| GEMINI GXL (K051170) | Philips Medical Systems (Cleveland), Inc. | 2005-05-23 |
| POLYAXIAL HEMISPHERICAL SPINAL SCREWS (K051063) | Scient'X | 2005-05-23 |
| INTEGRA IMMOBILIZATION SYSTEM (K050888) | Diacor, Inc. | 2005-05-23 |
| ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2 (K050305) | Bioscreen Medical, Inc. | 2005-05-23 |
| TITANIUM-HIP TOOL (K051032) | Orthopedic Sciences, Inc. | 2005-05-23 |
| REPROCESSED ENDOSCOPIC TROCAR (K043592) | Sterilmed, Inc. | 2005-05-23 |
| VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE (K050976) | bioMerieux, Inc. | 2005-05-23 |
| GE VIEWPOINT (K050943) | General Electric Co. | 2005-05-23 |
| FT2000 SEQUENCER FOR MUSCLE STIMULATOR (K050595) | Midwest Development | 2005-05-23 |
| GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN (K050963) | Mds Nordion | 2005-05-20 |
| ACON +/- MIDSTREAM PREGNANCY TEST (K050546) | ACON Laboratories, Inc. | 2005-05-20 |
| ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM (K043197) | Lifescan, Inc. | 2005-05-20 |
| WIMRT MODULE FOR ARTP PLANNING SYSTEM (K041971) | Prodigm Group, Inc. | 2005-05-20 |
| XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM (K050534) | Abbott Laboratories | 2005-05-20 |
| ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 (K050748) | Scantibodies Laboratory, Inc. | 2005-05-20 |
| D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL FILTER (K051232) | Dideco S.R.L. | 2005-05-20 |
| THE HERMES SYSTEM (K050929) | Palaistra Systems, Inc. | 2005-05-20 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TRIMETHOPRIM-SULFAMETHOXAZOLE 0.0625/1.2-16/304 UG/ML (K050865) | Becton, Dickinson & CO | 2005-05-20 |
| MOTIFMESH SOFT TISSUE PATCH (K050678) | Proxy Biomedical , Ltd. | 2005-05-20 |
| ATLANTIS PV (K050684) | Boston Scientific Corp | 2005-05-20 |
| FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P (K050907) | Fujinon, Inc. | 2005-05-19 |
| SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM (K050731) | Ge Medical Systems Information Technologies | 2005-05-19 |
| FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE (K051000) | Spinal Concepts, Inc. | 2005-05-19 |
| ENPATH DEFLECTABLE CATHETER (K043489) | Enpath Medical Incorporated | 2005-05-19 |
| LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS (DEN050002) | Wako Chemicals USA, Inc. | 2005-05-19 |
| TIUNITE IMPLANTS (K050705) | Nobel Biocare AB | 2005-05-19 |
| POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,PINK,GREEN,BLACK) (K050528) | Spi Gloves Sdn. Bhd. | 2005-05-19 |
| SIS DERMAL AUGMENTATION STRAND (K050246) | Cook Biotech, Inc. | 2005-05-19 |
| HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY (K051079) | Hospicare, Inc. | 2005-05-19 |
| ADAPTER CABLE (K050884) | Remington Medical, Inc. | 2005-05-19 |
| INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS (K051182) | Inovel, LLC | 2005-05-19 |
| CARDIOSCOPE SONOPLUS 3000 (K051126) | Pulsonic Ag, Medical Technology | 2005-05-19 |
| STRYKER DISCMONITOR (K050753) | Stryker Instruments | 2005-05-18 |
| EUTROCHAR (K050957) | Special Devices, Inc. | 2005-05-18 |
| BIOPRO TARA FEMORAL RESURFACING COMPONENT (K043542) | Biopro, Inc. | 2005-05-18 |
| LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTION ABLATOR (K050923) | Conmed Linvatec | 2005-05-18 |
| SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM (K050608) | Synthes (Usa) | 2005-05-18 |
| PRECIMED CANNULATED SCREW SYSTEM (K050754) | Precimed, Inc. | 2005-05-18 |
| ANS SCS ACCESSORY KIT (K050922) | Advanced Neuromodulation Systems | 2005-05-18 |
| PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS (K050948) | Bausch & Lomb, Inc. | 2005-05-18 |
| LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER (K050168) | Vascular Solutions, Inc. | 2005-05-18 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) (K051153) | Hebei Manful Import & Export Co., Ltd. | 2005-05-18 |
| CELLERATION MIST THERAPY SYSTEM 5.1 (K050129) | Celleration, Inc. | 2005-05-17 |
| APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582 (K051096) | St. Jude Medical, Daig Division, Inc. | 2005-05-17 |
| RANDOX BENZODIAZEPINE CLASS ASSAY (K050179) | Randox Laboratories, Ltd. | 2005-05-17 |
| INTERX5000 (K042912) | Neuro Resource Group, Inc. | 2005-05-17 |
| IPLAN! DIGITAL TEMPLATING (K042543) | Brainlab AG | 2005-05-17 |
| NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS (K050105) | Zimmer, Inc. | 2005-05-17 |