| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - LINEZOLID (STREP) 0.25 - 16UG/ML (K051266) | Becton, Dickinson & CO | 2005-07-05 |
| DCL MICROALBUMIN ASSAY, MODEL 252-20 (K051191) | Diagnostic Chemicals , Ltd. | 2005-07-05 |
| TRANSEAR BONE CONDUCTION HEARING AID (K050653) | United Hearing Systems, Inc. | 2005-07-01 |
| SYMBIOS DISPOSABLE INFUSION PUMP KIT (K051474) | Symbios Medical Products, LLC | 2005-07-01 |
| SMITH & NEPHEW CDS SYSTEM (K051136) | Smith & Nephew, Inc. | 2005-07-01 |
| THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS (K051106) | Philips Medizin Systeme Boeblingen GmbH | 2005-07-01 |
| 55 SV, MULTIFOCAL AND TORIC (OCUFILCON C) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K051184) | United Contact Lens, Inc. | 2005-07-01 |
| INSTANT-X, MODELS 1713 & 128 (K042791) | Ann Arbor Digital Devices | 2005-07-01 |
| LUMIPHASE-R (K051255) | Opusmed, Inc. | 2005-07-01 |
| MICK HDR INTERSTITIAL IMPLANT ACCESSORIES (K051423) | Mick Radio-Nuclear Instruments, Inc. | 2005-07-01 |
| OMEGA EXCEL/XP LASER SYSTEM (K043353) | Advanced Medical Technologies, Inc. | 2005-07-01 |
| COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS (K041653) | Standard Textile Co., Inc. | 2005-07-01 |
| DIRECT DIGITIZER REGIUS MODEL 370 (K051418) | Konica Minolta Medical & Graphic, Inc. | 2005-07-01 |
| TESLAOXYSAT, MODEL EFOXYSATE (K050018) | Mammendorfer Institute For Physics & Medicine GmbH | 2005-07-01 |
| GF-UE160-AL5 ULTRASOUND ENDOSCOPE (K051541) | Olympus America, Inc. | 2005-07-01 |
| NAVIGATOR (K042875) | Nomos Corp. | 2005-07-01 |
| PMP4 MEDICAL WEB CENTER (K050940) | Card Guard Scientific Survival , Ltd. | 2005-07-01 |
| EYE-CEPT REWETTING DROPS (K041008) | Optics Laboratory, Inc. | 2005-07-01 |
| TRABECULAR METAL PRIMARY HIP PROSTHESIS (K051491) | Zimmer, Inc. | 2005-06-30 |
| PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES (K050803) | Vitaid, Ltd. | 2005-06-30 |
| TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS (K051557) | Smith & Nephew, Inc. | 2005-06-30 |
| CREATININE LIQUICOLOR (K050283) | Stanbio Laboratory | 2005-06-30 |
| DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR (K050266) | Stanbio Laboratory | 2005-06-30 |
| PENTATRASFU BLOOD TRANSFUSION SETS (K041496) | Pentaferte S.P.A | 2005-06-30 |
| WAVELIGHT AURIGA (K051399) | Wavelight Laser Technologie AG | 2005-06-30 |
| 6 FR FL POWERHOHN AND POWERLINE CATHETER (K051417) | C.R. Bard, Inc. | 2005-06-30 |
| MC+ PARTIAL VBR (K043479) | Ldr Spine USA | 2005-06-30 |
| AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE (K050953) | Air Safety, Ltd. | 2005-06-29 |
| SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092 (K051050) | Schutz-Dental GmbH | 2005-06-29 |
| INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS (K051408) | Intelifuse, Inc. | 2005-06-29 |
| MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS (K050802) | Intuitive Surgical, Inc. | 2005-06-29 |
| DADE THROMBIN REAGENT (K050928) | Dade Behring, Inc. | 2005-06-29 |
| STALIF TT (K051027) | Surgicraft , Ltd. | 2005-06-29 |
| SUPER VIEW DISPOSABLE BIOM LENS SET (K051630) | Insight Instruments, Inc. | 2005-06-29 |
| STAR 50 MONITORING SYSTEM (K051608) | Larsen & Toubro Limited | 2005-06-29 |
| OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI) (K043349) | Ldr Spine USA | 2005-06-29 |
| TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS (K050799) | Biosite Incorporated | 2005-06-29 |
| CARDIODAY (K051471) | Getemed Medizin- Und Informationstechnik AG | 2005-06-29 |
| MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS) (K051448) | Medoc Ltd. Advanced Medical Systems | 2005-06-29 |
| MONOCRYL PLUS ANTIBACTERIAL SUTURE (K050845) | ETHICON, Inc. | 2005-06-29 |
| ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM (K050858) | Heartlab, Inc. | 2005-06-29 |
| ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES (K051554) | Alliance Medical Corp. | 2005-06-29 |
| BTI-SCAN, VERSION 4.0 (K051392) | B.T.I. Biotechnology Institute, Sl. | 2005-06-29 |
| PUSHLOCK (K051219) | Arthrex, Inc. | 2005-06-29 |
| JAN MAO WHEELCHAIR, MODEL JMC612-F18EPP (K051482) | Jan Mao Industries Co., Ltd. | 2005-06-29 |
| BARRX HALO 360 SYSTEM, MODEL 1100C-115A (K051168) | Barrx Medical, Incorporated | 2005-06-29 |
| VISULIZE FACTOR IX ANTIGEN KIT (K051054) | Affinity Biologicals, Inc. | 2005-06-29 |
| R-X-FIX EXTERNAL FIXATOR (K051017) | R-X-Fix | 2005-06-29 |
| ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS (K051411) | Biomet, Inc. | 2005-06-29 |
| NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER (K051069) | Arthrotek, Inc. | 2005-06-29 |
| TAPER 2 POROUS FEMORAL STEM (K050441) | Biomet, Inc. | 2005-06-29 |
| JAN MAO WHEELCHAIR, MODEL JMC611-F18EPP (K051481) | Jan Mao Industries Co., Ltd. | 2005-06-29 |
| DATEX-OHMEDA OXY-AFR SENSOR (K042891) | Datex-Ohmeda | 2005-06-29 |
| MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) (K050954) | MicroVention, Inc. | 2005-06-28 |
| CAC-127-8 CARDOAC ARRAY COIL (K051512) | Invivo Corp. | 2005-06-28 |
| AMSURE 100% SILICONE FOLEY CATHETER (K051059) | Amsino International, Inc. | 2005-06-28 |
| NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR (K051560) | Micro Therapeutics, Inc. | 2005-06-28 |
| VARELISA RECOMBI CTD SCREEN, MODEL 13096 (K050967) | Sweden Diagnostics (Germany) GmbH | 2005-06-28 |
| HBA1C ENZYMATIC ASSAY (K050178) | General Atomics | 2005-06-28 |
| OPEN BREAST COIL (OBC) WITH BIOPSY PLATES (K050728) | Usa Instruments, Inc. | 2005-06-28 |
| MODIFICATION TO:REGISTRADO X-TRA (K051535) | Voco GmbH | 2005-06-28 |
| SMALL INTESTINAL VIDEOSCOPE SYSTEM (K051551) | Olympus Medical Systems Corporation | 2005-06-28 |
| IMAGEQUBE PACS (K051037) | Intuitive Imaging Informatics, LLC | 2005-06-28 |
| REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION (K051521) | Konica Minolta Medical & Graphic, Inc. | 2005-06-28 |
| FISHVIEW (K050236) | Applied Spectral Imaging , Ltd. | 2005-06-27 |
| FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM (K050500) | Abbott Diabetes Care, Inc. | 2005-06-27 |
| CYNERGY MULTIPLEX LASER (K050779) | Cynosure, Inc. | 2005-06-27 |
| 19-INCH (48 CM) COLOR LCD MONITOR CDL1902A (K051331) | Totoku Electric Co., Ltd. | 2005-06-27 |
| CAPILLARY'S IMMUNOTYPING (PN 2100) (K042939) | Sebia, Inc. | 2005-06-27 |
| FES CYCLE ERGOMETER, MODEL RT300-S (K050036) | Restorative Therapies, Inc. | 2005-06-27 |
| REVLIGHT SKIN CARE SYSTEM (K042630) | Skincare Technology, Inc. | 2005-06-27 |
| ZOLL M SERIES 12SL ANALYSIS OPTION (K051475) | ZOLL Medical Corporation | 2005-06-24 |
| LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER (K051395) | Vascular Solutions, Inc. | 2005-06-24 |
| BPCALIBRATOR MC3000/MC3100 (K051546) | Healthstats International Pte. , Ltd. | 2005-06-24 |
| MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS (K051088) | Lin-Zhi International, Inc. | 2005-06-24 |
| MODIFICATION TO: CERCON BASE (K051462) | Dentsply Intl. | 2005-06-24 |
| NXSTAGE SYSTEM ONE (K050525) | Nxstage Medical, Inc. | 2005-06-24 |
| PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL) (K051464) | Planmeca Oy | 2005-06-24 |
| ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE (K050936) | ACON Laboratories, Inc. | 2005-06-24 |
| CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR (K050877) | Biosense Webster, Inc. | 2005-06-24 |
| SHL DISPOSABLE AUTOINJECTOR (K050434) | Shl Medical, USA | 2005-06-24 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFEPIME (STREP) 0.0625-4UG/ML (K051204) | Becton, Dickinson & CO | 2005-06-24 |
| ENDOTINE RIBBON (K051415) | Coapt Systems, Inc. | 2005-06-23 |
| SYNTHACER; SYNTRICER (K041177) | Medartis Medizinprodukte Und Forschung AG | 2005-06-23 |
| MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE (K051283) | Cardiopulmonary Corp. | 2005-06-23 |
| CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (K051374) | Stereotaxis, Inc. | 2005-06-23 |
| DRIED GRAM-POSITIVE MIC/COMBO PANELS (K051202) | Dade Behring, Inc. | 2005-06-23 |
| XAWEX G 100 (K050903) | Wieland Dental + Technik GmbH & Co. KG | 2005-06-23 |
| JET BLUE BITE (K051243) | Coltene/Whaledent AG | 2005-06-23 |
| 3.0T PROSTATE IMAGING SYSTEM (K051349) | Medrad, Inc. | 2005-06-23 |
| RESTORATION MODULAR SYSTEM (K051363) | Howmedica Osteonics Corp. | 2005-06-23 |
| ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50 (K050424) | Fim Medical | 2005-06-23 |
| COLORED POWDER FREE AND POLYMER COATED PATIENT EXAMINATION GLOVE (PINK, BLUE, GREEN AND VIOLET) (K051345) | Glovco (M) Sdn. Bhd. | 2005-06-23 |
| 750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL (K050844) | Cas Medical Systems, Inc. | 2005-06-23 |
| PERIPHERAL CUTTING BALLOON (K051254) | Boston Scientific Ivt | 2005-06-22 |
| MD TURBO (K051284) | Respirics, Inc. | 2005-06-22 |
| CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM (K050852) | I.T.S. Implantat-Technologie-Systeme GmbH | 2005-06-22 |
| ZODIAC SPINAL FIXATION SYSTEM (K050830) | Alphatec/Nexmed | 2005-06-22 |
| INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET (K051499) | Medegen Medical Manufacturing Services | 2005-06-22 |
| NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR (K051425) | Micro Therapeutics, Inc. | 2005-06-22 |