| VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS (K050222) | Biomet, Inc. | 2005-08-16 |
| QUANTIA BETA-2 MICROGLOBULIN (K050613) | Biokit, S.A. | 2005-08-16 |
| VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE (K051849) | bioMerieux, Inc. | 2005-08-16 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES WHITE (NON-COLORED) (K051923) | Shijiazhuang Wonder Plastic Co., Ltd. | 2005-08-16 |
| ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL (K052044) | Acmi Corporation | 2005-08-16 |
| DRUG ACCESS SPIKE (K051930) | Medegen Medical Manufacturing Services | 2005-08-16 |
| LYSUS INFUSION SYSTEM (K052071) | Ekos Corp. | 2005-08-16 |
| VPAP ADAPT (K051364) | Resmed, Ltd. | 2005-08-16 |
| MELIDE FIBEROPTIC LIGHT (K051786) | Designs For Vision, Inc. | 2005-08-15 |
| OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR (K051700) | Medchannel, LLC | 2005-08-15 |
| C CHANGE SOLUTION WARMER (K051819) | C Change Surgical, LLC | 2005-08-15 |
| HIPPOCAMPE WHEELCHAIR (K051709) | Vipamat Technologie | 2005-08-15 |
| FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM (K050575) | Futumeds Sdn Bhd | 2005-08-15 |
| BIOBLANKET SURGICAL MESH (K043259) | Kensey Nash Corp. | 2005-08-15 |
| 3L SURGICAL DRAPES (K043015) | 3l Medical Products Co., Ltd. | 2005-08-15 |
| EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM (K051809) | Medical Insight A/S | 2005-08-15 |
| FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT (K050320) | Ascendia Medtech AB | 2005-08-15 |
| KARL STORZ TRANS-NASAL ESOPHAGOSCOPE (K051972) | KARL STORZ Endoscopy-America, Inc. | 2005-08-15 |
| STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES (K051615) | Regeneration Technologies, Inc. | 2005-08-15 |
| ULTRAPACS (K051813) | Ultrarad Corporation | 2005-08-15 |
| HABIB 4X (K051420) | Emcision , Ltd. | 2005-08-15 |
| VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40 (K052130) | Vident | 2005-08-15 |
| U2 ACETABULAR COMPONENT (K050262) | United Orthopedic Corp. | 2005-08-15 |
| VCS S3T (K051131) | Cycling and Health Tech. Industry R&D Center/Chc | 2005-08-15 |
| EXCEL BARIATRIC OR EXCEL SHUTTLE WHEELCHAIR (K051302) | Medline Industries, Inc. | 2005-08-15 |
| MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 3 (K051613) | Olympus Medical Systems Corporation | 2005-08-15 |
| ENSITE VERISMO SOFTWARE (K051840) | St Jude Medical | 2005-08-15 |
| ECLIPSE NEUROLOGICAL WORKSTATION (K050798) | Axon Systems, Inc. | 2005-08-15 |
| GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING (K051606) | Gish Biomedical, Inc. | 2005-08-12 |
| BIOGEL LATEX STERILE POWDER-FREE GLOVE (K050899) | Regent Medical Americas, LLC | 2005-08-12 |
| DISCON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K051129) | Innova Vision, Inc. | 2005-08-12 |
| TRIO MONITOR (K051897) | Datascope Corp. | 2005-08-12 |
| HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS (K051748) | C.R. Bard, Inc. | 2005-08-12 |
| CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE (K052097) | Dentsply International | 2005-08-12 |
| ORTHOCON LLC ORTHOSTAT HEMOSTATIC BONE PUTTY (K043260) | Orthocon, LLC | 2005-08-12 |
| STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014 (K051370) | Baxter Healthcare Corp | 2005-08-12 |
| ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 (K051932) | Elekta, Inc. | 2005-08-12 |
| NITRILE POWDER FREE EXAMINATION GLOVES (BLUE) (K051777) | Hartalega Sdn Bhd | 2005-08-12 |
| CLEVER TD-3018A BLOOD PRESSURE MONITOR (K051703) | Taidoc Technology Corporation | 2005-08-12 |
| ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR (K051900) | Johnson & Johnson Vision Care, Inc. | 2005-08-12 |
| JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINOSCOPE/MULTISCOPE (K051827) | Joimax GmbH | 2005-08-12 |
| 506 PATIENT MONITOR (K051038) | Ciriticare Systems, Inc. | 2005-08-12 |
| MODIFICATION TO ABL800 FLEX (K050869) | Radiometer Medical Aps | 2005-08-11 |
| VALLEYLAB FORCETRIAD ELECTROSURGICAL GENERATOR (K051644) | Valleylab | 2005-08-11 |
| SCB/STERIS OR-LIGHT INTERFACE BOX (K051505) | KARL STORZ Endoscopy-America, Inc. | 2005-08-11 |
| NIO 2MP-21 (K051902) | Barcoview | 2005-08-11 |
| VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT (K051071) | Viramed Biotech AG | 2005-08-11 |
| OXIMAX NPB-40 HANDHELD PULSE OXIMETER (K051352) | Nellcor Puritan Bennett, Inc. | 2005-08-11 |
| GE OEC ALTITUDE (K052039) | Ge Oec Medical Systems | 2005-08-11 |
| SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES) (K052109) | Sonosite,Inc. | 2005-08-11 |
| BIOPLANT (K050984) | Kerr Dental Materials Center | 2005-08-11 |
| BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT (K051169) | Viramed Biotech AG | 2005-08-11 |
| MODEL SR-115 PORTABLE X-RAY SYSTEM (K052001) | Source-Ray, Inc. | 2005-08-11 |
| I-STOP (K051533) | Cl Medical | 2005-08-11 |
| MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH (K052100) | Proxy Biomedical , Ltd. | 2005-08-11 |
| SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079 (K051848) | Davol Inc., Sub. C. R. Bard, Inc. | 2005-08-11 |
| AXIOM NVP8500 (K051135) | Axiom Worldwide, Inc. | 2005-08-11 |
| ORTHOMEND (K051766) | Tei Biosciences, Inc. | 2005-08-11 |
| PILONPLATE WITH ANGULAR STABILITY (K052011) | I.T.S. Implantat-Technologie-Systeme GmbH | 2005-08-10 |
| CHARLOTTE COMPRESSION PLATE (K051908) | Wrightmedicaltechnologyinc | 2005-08-10 |
| 100W CERALAS D 980 LASER SYSTEM, MODEL D100 (K050824) | Biolitec, Inc. | 2005-08-10 |
| AQUIFY MULTIPURPOSE SOLUTION (K050250) | Ciba Vision Corporation | 2005-08-10 |
| SBI K-WIRES (K051605) | Small Bone Innovations, LLC | 2005-08-10 |
| RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS (K051479) | Biomet Manufacturing, Inc. | 2005-08-10 |
| QUICKCLOT ACS - ACCELERATED CLOTTING SPONGE (K051955) | Z-Medica Corporation | 2005-08-10 |
| CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM (K051941) | Accuray, Inc. | 2005-08-09 |
| MULTIPLE EROZONE BODYGLIDE FLUID, EROZONE BODYGLIDE GEL, EROZONE LATEX DRESSING, EROZONE BODYGLIDE NATURAL FOAM (K040428) | R & K International Cosmetics | 2005-08-09 |
| CLEARFIL TRI-S BOND SINGLE DOSE (K051796) | Kuraray Medical Kurashiki Plant | 2005-08-09 |
| OMNILUX REVIVE AND OMNILUX PLUS (K050216) | Photo Therapeutics Limited | 2005-08-09 |
| BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE (K050446) | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2005-08-09 |
| SYNGO CIRCULATION (K052029) | Siemens AG Medical Solutions | 2005-08-09 |
| FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM (K051802) | Abbott Diabetes Care, Inc. | 2005-08-09 |
| ORTHOSCAN, ORTHOSCAN HD (K051754) | Orthoscan, Inc. | 2005-08-09 |
| DP-6600 ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K052113) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005-08-09 |
| SONOSCAPE SSI-1000/SSI-5000 ULTRASOUND TRANSDUCERS (K052042) | Sonoscape Company Limited | 2005-08-09 |
| BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM (K051368) | Schiller AG | 2005-08-09 |
| GEN-PROBE APTIMA COMBO 2 ASSAY (K043224) | Gen-Probe, Inc. | 2005-08-09 |
| VTRAC EXCIMER LAMP SYSTEM (K051428) | Photo Medex, Inc. | 2005-08-09 |
| COOLTOUCH ND:YAG LASER SYSTEMS, MODELS CT3S AND CTEV (K051434) | New Star Lasers, Inc. | 2005-08-09 |
| LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK (K052053) | Bio-Rad | 2005-08-09 |
| REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS (K051967) | GE Healthcare | 2005-08-09 |
| SILENT PARTNER SERIES OSA APPLIANCES (K051014) | Dreamwrx Dental Laboratory | 2005-08-09 |
| ENDOSCOPIC APPLICATOR (K051732) | ETHICON, Inc. | 2005-08-09 |
| Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM (K050182) | Biomedix, Inc. | 2005-08-09 |
| CLEVER CHECK TD-3215/DR. T TD-3216 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEMS (K051936) | Taidoc Technology Corporation | 2005-08-08 |
| CRP DIAGNOSTIC ASSAY (K050836) | Sentinel Ch. Srl | 2005-08-08 |
| VASCULAR SOLUTIONS PRONTO SHORT EXTRACTION CATHETER (K051193) | Vascular Solutions, Inc. | 2005-08-08 |
| SLIVASURE (K051409) | Scandinavian Formulas, Inc. | 2005-08-08 |
| DIVER C.E. CATHETER (K051917) | Invatec Innovative Technologies, S.R.L. | 2005-08-08 |
| DIRECT LDL CHOLESTEROL, MODEL L530-60H (K051121) | Teco Diagnostics | 2005-08-08 |
| HEMOGLOBIN A1C REAGENT SET (K051200) | Teco Diagnostics | 2005-08-08 |
| IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER (K051199) | Sysmex America, Inc. | 2005-08-08 |
| ESTELITE FLOW QUICK (K051808) | Tokuyama Dental Corporation | 2005-08-08 |
| MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005 (K050655) | Kapp Surgical Instrument, Inc. | 2005-08-08 |
| MONDEAL CONTOUR HO SYSTEM (K050657) | Kapp Surgical Instrument, Inc. | 2005-08-08 |
| DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES. (K051883) | GE Healthcare | 2005-08-05 |
| PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH (K043388) | Pegasus Biologics, Inc. | 2005-08-05 |
| 7F SHERPA NX GUIDE CATHETER (K051846) | Medtronic Vascular | 2005-08-05 |
| DEPUY ASR MODULAR ACETABULAR CUP SYSTEM (K040627) | DePuy Orthopaedics, Inc. | 2005-08-05 |
| AVL HINGE KNEE SYSTEM (K051570) | Biomet, Inc. | 2005-08-05 |