| SIJF CANNULATED SCREW SYSTEM (K051296) | Depuy Spine, Inc. | 2005-08-26 |
| GR17 DIGITAL DETECTOR (K052136) | Anrad Corp. | 2005-08-25 |
| SENTINEL IRON LIQUID (K051115) | Sentinel Ch. Srl | 2005-08-25 |
| ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES (K052062) | Alliance Medical Corp. | 2005-08-25 |
| INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ (K052157) | Ge Medical Systems, LLC | 2005-08-25 |
| BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP (K052114) | Bard Peripheral Vascular, Inc. | 2005-08-25 |
| REMOTE CARE (K050234) | E.Care Solutions, Inc. | 2005-08-25 |
| ATB ADVANCE PTA DILATATION CATHETER (K052036) | Cook, Inc. | 2005-08-25 |
| MATRYX INTERFERENCE SCREW (K052080) | Linvatec Biomaterials, Inc. | 2005-08-25 |
| ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES (K052064) | Alliance Medical Corp. | 2005-08-25 |
| ULTRA HDL (K051962) | Abbott Laboratories | 2005-08-25 |
| ASAHI PTCA GUIDE WIRE FIELDER (K052022) | Asahi Intecc Co., Ltd. | 2005-08-25 |
| ACCESS BREAST COIL (K052045) | Confirma, Inc. | 2005-08-24 |
| SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR (K052194) | Boston Scientific Corp | 2005-08-24 |
| H12+ HOLTER RECORDER (K050896) | Mortara Instrument, Inc. | 2005-08-24 |
| MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM (K052132) | Edwards Lifesciences, LLC | 2005-08-24 |
| OPD-STATION SOFTWARE (K050336) | Nidek, Inc. | 2005-08-24 |
| HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5 (K052052) | Hospira, Inc. | 2005-08-24 |
| UNIGLIDE UNICONDYLAR KNEE PROSTHESIS (K050764) | Corin USA | 2005-08-24 |
| APTUS TITANIUM OSTEOSYNTHESIS SYSTEM (K051567) | Medartis, Inc. | 2005-08-23 |
| BARD ATLAS PTA BALLOON DILATATION CATHETER (K052236) | Bard Peripheral Vascular, Inc. | 2005-08-23 |
| ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE (K051376) | Roche Diagnostics | 2005-08-23 |
| PC COMPATIBLE BLOOD PRESSURE MONITOR, MODEL AK-4000TU, BP-410U, BP-410R; AUTOMATIC DIGITAL WRIST BLOOD PRESS. MONITOR. (K051862) | Ya Horng Electronic Co., Ltd. | 2005-08-23 |
| FORMULA 418 BILIARY STENT (K051785) | Cook, Inc. | 2005-08-23 |
| MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM (K052180) | Medtronic Sofamor Danek | 2005-08-23 |
| VITALCARE I.V. ADMINISTRATION SET (K050906) | Vitalcare Group, Inc. | 2005-08-23 |
| CUTANEOUS ELECTRODE (K052188) | Rhythmlink International, LLC | 2005-08-23 |
| GAV - GENERAL ANAESTHETIC VAPORIZER (K051666) | General Anaesthetic Services Limited | 2005-08-23 |
| DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES (K052145) | GE Healthcare | 2005-08-23 |
| GC FUJI FIL LC (K051427) | GC America, Inc. | 2005-08-22 |
| IRON STANDARD (K052002) | Roche Diagnostics Corp. | 2005-08-22 |
| RESORB-X SF (K051236) | KLS-Martin L.P. | 2005-08-22 |
| WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST (K051841) | W.H.P.M., Inc. | 2005-08-22 |
| NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE) (K050827) | Dialysis Solutions, Inc. | 2005-08-22 |
| MODIFICATION TO EN-BLOC BIOPSY SYSTEM (K052246) | Neothermia Corporation | 2005-08-22 |
| ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES (K052065) | Alliance Medical Corp. | 2005-08-22 |
| BISCOVER LED (K051999) | Bisco, Inc. | 2005-08-22 |
| MODIFICATION TO: CD HORIZON SPINAL SYSTEM (K052187) | Medtronic Sofamor Danek | 2005-08-22 |
| MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM (K051946) | Medartis, Inc. | 2005-08-22 |
| MODIFICATION TO: TITANIUM TELEGRAPH HUMERAL NAIL (K052058) | Fournitures Hospitalieres Industrie | 2005-08-22 |
| CARDIOSTREAM SONOAIM (K051853) | Cardiostream, LLC | 2005-08-22 |
| RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE (K051947) | Radionics, A Division of Tyco Healthcare Group LP | 2005-08-22 |
| MILLIKEN SILVER WOUND DRESSINGS (K051445) | Milliken Chemical | 2005-08-22 |
| OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH (K051564) | Olympus America, Inc. | 2005-08-22 |
| PROFEMUR RENAISSANCE HIP STEM (K051995) | Wrightmedicaltechnologyinc | 2005-08-22 |
| FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 (K051860) | Epimed International, Inc. | 2005-08-22 |
| FR.O.H. CALCANEUS REPAIR SYSTEM (K051642) | I.T.S. Implantat-Technologie-Systeme GmbH | 2005-08-22 |
| OX-GEN FLEXIBLE O2 GENERATION SYSTEM, MODEL 6-OX-03 (K033863) | Ox-Gen, Inc. | 2005-08-22 |
| AMLUCK, YA HORNG (K051863) | Ya Horng Electronic Co., Ltd. | 2005-08-19 |
| CONSERVE TOTAL FEMORAL HEAD (K051348) | Wrightmedicaltechnologyinc | 2005-08-19 |
| DELTA PUNCTUM PLUG (K050851) | Delta Life Science, Inc. | 2005-08-19 |
| DIVAS DUAL PLEASURE MALE LATEX CONDOM (K051273) | Eagle Twe, Inc. | 2005-08-19 |
| DVT SCANNER (K051980) | Imaging Sciences Intl., Inc. | 2005-08-19 |
| CARDIONAVIGATOR + (K051960) | Del Mar Reynolds Medical, Ltd. | 2005-08-19 |
| TEM 3000 HEAD COIL (K052200) | Mr Instruments, Inc. | 2005-08-19 |
| VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001 (K051920) | Volcano Corporation | 2005-08-19 |
| STERRAD STERILIZER CYCLESURE TEST PACK (K051643) | Advanced Sterilization Products | 2005-08-19 |
| FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 (K052082) | Beckman Coulter, Inc. | 2005-08-19 |
| VYGON NUTRILINE CATHETERS (K051690) | Vygon Corp. | 2005-08-19 |
| INCLOSE SURGICAL MESH SYSTEM (K050969) | Anulex Technologies, Inc. | 2005-08-18 |
| MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM (K052166) | Guidant Corporation | 2005-08-18 |
| EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX; VOLCANO VH-IVUS SYSTEM, MODEL 8049XX-001 (K051337) | Volcano Corporation | 2005-08-18 |
| 2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011 (K043465) | Spectranetics Corp. | 2005-08-18 |
| MICROPULSE PHACOEMULSIFICATION SYSTEM (K051186) | Trillium Medical, Inc. | 2005-08-18 |
| INVADER UGT1A1 MOLECULAR ASSAY (K051824) | Third Wave Technologies, Inc. | 2005-08-18 |
| CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5 (K051305) | Cs Medical, LLC | 2005-08-18 |
| DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DELTA 30 (K051996) | Diomed, Ltd. | 2005-08-18 |
| MODIFICATION TO: XIA STAINLESS STEEL SYSTEM (K051973) | Stryker Spine | 2005-08-18 |
| TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING (K043075) | Tenacore Holdings, Inc. | 2005-08-18 |
| COLONIC AND ENEMA NOZZLE (K051344) | Ultimate Concepts, Inc. | 2005-08-18 |
| RESOLVE OPEN BACK HALO RINGS (K051918) | Jerome Medical | 2005-08-17 |
| IQ BODY FLUIDS CONTROL (K051706) | Streck | 2005-08-17 |
| PENUMBRA ASPIRATION PUMP, MODEL 115V (K051758) | Penumbra, Inc. | 2005-08-17 |
| PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES (K052069) | Globus Medical, Inc. | 2005-08-17 |
| ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE) (K051793) | Ansell Healthcare Products, LLC | 2005-08-17 |
| XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382 (K052111) | Excel Tech. , Ltd. | 2005-08-17 |
| NIO 3MP-21 (K051901) | Barcoview | 2005-08-17 |
| SILBRONCHO DOUBLE LUMEN TUBE (K051522) | Fuji Systems Corp. | 2005-08-17 |
| V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER (K052021) | Siemens Medical Solutions USA, Inc. | 2005-08-17 |
| BIOVALVE MINI-JECT NEEDLEFREE INJECTOR (K051985) | Biovalve Technologies, Inc. | 2005-08-17 |
| STRATUS CS D-DIMER (K051597) | Dade Behring, Inc. | 2005-08-17 |
| MEE-1000A NEUROMASTER (K051178) | Nihon Kohden America, Inc. | 2005-08-17 |
| VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT (K050644) | Vancouver Biotech , Ltd. | 2005-08-17 |
| QUANTIA IGE (K050493) | Biokit, S.A. | 2005-08-16 |
| MODIFICATION TO DUET SYSTEM (K050840) | Bioview , Ltd. | 2005-08-16 |
| CD-CHEX PLUS BC (K051633) | Streck | 2005-08-16 |
| COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM (K050821) | Zycare | 2005-08-16 |
| NUBIC SPINAL IMPLANT (K052096) | Signus Medical, LLC | 2005-08-16 |
| 3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER (K052128) | 3M Company | 2005-08-16 |
| PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM (K052038) | Boston Scientific Corporation | 2005-08-16 |
| SILFAB SUPER 2 MAX COMPRESSOR, N28 SERIES (K050183) | Silvestrin Fabris S.R.L. | 2005-08-16 |
| GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS (K051794) | Office of the Surgeon General, U.S. Army | 2005-08-16 |
| TSRH SPINAL SYSTEM (K052054) | Medtronic Sofamor Danek | 2005-08-16 |
| G-SCAN CERVICAL SPINE COIL (K052077) | Esaote, S.p.A. | 2005-08-16 |
| RX ACCUNET EMBOLIC PROTECTION SYSTEM (K052165) | Guidant Corporation | 2005-08-16 |
| BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS) (K050971) | Biovalve Technologies, Inc. | 2005-08-16 |
| 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K051095) | Optical Connection, Inc. | 2005-08-16 |
| VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU (K051282) | Tripath Imaging, Inc. | 2005-08-16 |
| TERUMO SYRINGE WITH/WITHOUT NEEDLE (K052034) | Terumo Medical Corp. | 2005-08-16 |
| URITEK-720+ URINE ANALYZER (K051526) | Teco Diagnostics | 2005-08-16 |