| SYNTHALON PI POWDER-FREE SYNTHETIC POLYISOPRENE/POLYCHLOROPRENE EXAMINATION GLOVES MDL 1362-10 TO 1362-44 (K060733) | Barriermed, Inc. | 2006-04-24 |
| DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM (K060640) | Dentamerica | 2006-04-24 |
| RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC (K052520) | Tianjin New Bay Bioresearch Co., Ltd. | 2006-04-24 |
| VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT (K060168) | Irvine Scientific Sales Co., Inc. | 2006-04-24 |
| ADPER PROMPT, ADPER PROMPT L-POP (K060684) | 3M Espe AG Dental Products | 2006-04-24 |
| BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850 (K060865) | Arizant Healthcare, Inc. | 2006-04-24 |
| VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III (K060940) | Ortho-Clinical Diagnostics, Inc. | 2006-04-24 |
| NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2) (K060462) | Lab Vision Corp. | 2006-04-24 |
| VARIAX LOCKING PLATE SYSTEM (K060613) | Howmedica Osteonics Corp. | 2006-04-21 |
| UNITY HUMERAL PLATE (K060545) | Tornier | 2006-04-21 |
| FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 (K060774) | Beckman Coulter, Inc. | 2006-04-21 |
| PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS (K060768) | Abbott Diabetes Care, Inc. | 2006-04-21 |
| ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE (K060466) | ACON Laboratories, Inc. | 2006-04-21 |
| BARRX HALO COAGULATION SYSTEM, BARRX HALO COAGULATION GENERATOR, BARRX COAGULATION CATHETER, MODELS 2200-115A, 1520F (K060169) | Barrx Medical, Incorporated | 2006-04-21 |
| SPRAYGENIX CRYO ABLATION SYSTEM (K060555) | Crymed Technologies, Inc. | 2006-04-21 |
| BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855 (K060646) | Monitex Industrial Co., Ltd. | 2006-04-21 |
| XLTEK EMU40 EEG HEADBOX, MODEL PK1072 (K053386) | Excel Tech. , Ltd. | 2006-04-21 |
| HL888SF (K060835) | Health & Life Co., Ltd. | 2006-04-21 |
| SURTRAK IMPLANTATION KIT (K060679) | North American Scientific, Inc. | 2006-04-21 |
| HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088 (K060806) | Hospira, Inc. | 2006-04-21 |
| MODIFICATION TO ENSITE SYSTEM, MODEL EE3000 (K060954) | St. Jude Medical, Inc.-Endocardial Solutions | 2006-04-21 |
| SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015- (K060621) | Tds Holdings, Inc. | 2006-04-21 |
| OHMEGA (K060166) | Medical Measurement Systems B.V. | 2006-04-21 |
| BURBANK TENACULUM (K060573) | Vascular Control Systems, Inc. | 2006-04-21 |
| MODIFICATION TO HEALTH BUDDY APPLIANCE (K060843) | Health Hero Network, Inc. | 2006-04-20 |
| COMFORT/IO IONTOPHORESIS ELECTRODES (K060579) | Pepin Mfg., Inc. | 2006-04-20 |
| NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR (K060625) | Micro Therapeutics, Inc. | 2006-04-20 |
| LADY COMP USA (K050094) | Lady Comp USA | 2006-04-20 |
| FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1 (K060382) | Ameriflo Corp. | 2006-04-19 |
| SONICATH ULTRA IMAGING CATHETER, 3.2F,20MHZ MODELS 37410/456221/C1020 (K060947) | Boston Scientific Corp | 2006-04-19 |
| SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES (K053599) | Spacelabs Medical, Inc. | 2006-04-19 |
| ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100 (K060962) | Byrne Medical, Inc. | 2006-04-19 |
| PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE (K060636) | C.R. Bard, Inc. | 2006-04-19 |
| GE LIGHTSPEED XTRA CT SCANNER SYSTEM (K060052) | Ge Medical Systems, LLC | 2006-04-19 |
| STRYKER INJECTABLE CEMENT (K060750) | Stryker Cmf | 2006-04-19 |
| EVOLVE MODULAR RADIAL HEAD (K060731) | Wrightmedicaltechnologyinc | 2006-04-19 |
| MODIFICATION TO: HI-ART SYSTEM (K060912) | Tomotherapy Incorporated | 2006-04-19 |
| PROBEAT WITH MGCS (K060834) | Hitachi , Ltd. | 2006-04-19 |
| IVIEW (K053306) | Ondemandsoft | 2006-04-19 |
| ABARIS (K053610) | Traxtal Technologies, Inc. | 2006-04-19 |
| SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE (K052947) | Source Production & Equipment Co., Inc. | 2006-04-19 |
| VITELCARE C-TURTLE PATIENT MONITORING SYSTEM (K060712) | Visual Telecommunications Network, Inc. | 2006-04-19 |
| CAAS MRV VERSION 3.0 (K060941) | Pie Medical Imaging BV | 2006-04-19 |
| ATRIA 3100, ATRIA 6100 (K060167) | Cardiac Science Corporation | 2006-04-19 |
| INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER (K060757) | Irvine Biomedical, Inc. | 2006-04-19 |
| MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION (K053356) | Ge Medical Systems Information Technologies | 2006-04-19 |
| MODEL EC9-4 TRANSDUCER (K060879) | Siemens Medical Solutions USA, Inc. | 2006-04-19 |
| MODIFICATION TO ENDOTINE RIBBON (K060828) | Coapt Systems, Inc. | 2006-04-19 |
| RESCUE IMPLANT SYSTEM (K053353) | Megagen Co., Ltd. | 2006-04-19 |
| JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT (K060815) | Bioform Medical, Inc. | 2006-04-18 |
| ELECSYS TSH CALSET W/MODELS 04738551 (K060754) | Roche Diagnostics Corp. | 2006-04-18 |
| SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM (K060025) | Spinal USA | 2006-04-18 |
| KLS MARTIN RIGID FIXATION - STERILE (K060177) | KLS Martin L.P. | 2006-04-18 |
| ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM (K060683) | Endius, Inc. | 2006-04-18 |
| CONSERVE PLUS QUADRAFIX ACETABULAR SHELL (K060356) | Wrightmedicaltechnologyinc | 2006-04-18 |
| RHS (K060438) | Tornier | 2006-04-18 |
| COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIAL WOUND DRESSING (K060804) | Covalon Technologies, Ltd. | 2006-04-18 |
| SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS (K060736) | Smith & Nephew, Inc. | 2006-04-18 |
| EUREKA INFUSION PUMP, MODELS EUREKA-IP, EUREKA-LF (K052817) | Universal Medical Technologies | 2006-04-17 |
| BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE (K052843) | Busse Hospital Disposables, Inc. | 2006-04-17 |
| APEXCAL (K060365) | Ivoclar Vivadent, Inc. | 2006-04-17 |
| BILISOFT PHOTOTHERAPY SYSTEM (K053568) | Lumitex, Inc. | 2006-04-17 |
| FDS INTIMATE AND INTIMATE WARMING LUBRICANT (K060145) | Alberto-Culver USA, Inc. | 2006-04-14 |
| G4, MODEL IGM-0004 (K051651) | U. S. Diagnostics, Inc. | 2006-04-14 |
| GREEN LOVE MALE CONTRACEPTIVE (CONDOM) (K051842) | Cupid Condom, Ltd. | 2006-04-14 |
| GUAVA EZCD4 SYSTEM (K053497) | Guava Technologies, Inc. | 2006-04-14 |
| MODIFICATION TO VERTE-STACK SPINAL SYSTEM (K060719) | Medtronic Sofamor Danek | 2006-04-14 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN - 0.5-64 UG/ML (K060257) | Becton, Dickinson & CO | 2006-04-14 |
| SHERLOCK TIP LOCATION SYSTEM (TLS) (K060341) | C.R. Bard, Inc. | 2006-04-14 |
| ACCLAIM TOTAL ELBOW SYSTEM (K060696) | DePuy Orthopaedics, Inc. | 2006-04-14 |
| DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT (K053577) | Dade Behring, Inc. | 2006-04-14 |
| LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM (K060533) | Lenstec, Inc. | 2006-04-14 |
| KELO-COTE SPRAY (K053481) | Advanced Bio-Technologies, Inc. | 2006-04-14 |
| VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE SIGNA SYSTEMS (K060873) | Sentinelle Medical, Inc. | 2006-04-14 |
| ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10 (K060359) | Denka Seiken Co., Ltd. | 2006-04-14 |
| GALILEOS (K060892) | Sirona Dental Systems GmbH | 2006-04-14 |
| CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK (K060231) | Elcam Medical Acal | 2006-04-13 |
| NORIAN CRS FAST SET PUTTY (K060443) | Synthes (Usa) | 2006-04-13 |
| NORIAN CRS BONE CEMENT (K060445) | Synthes (Usa) | 2006-04-13 |
| HEMOGLOBIN ALC CONTROL (K060570) | Compass Bioscience | 2006-04-13 |
| HEMOSIL SYNTHASIL (K060688) | Instrumentation Laboratory CO | 2006-04-13 |
| SMITH & NEPHEW MODEL 660HD IMAGE MANAGEMENT SYSTEM (K060777) | Smith & Nephew, Inc. | 2006-04-13 |
| PICSI SPERM SELECTION DEVICE (K052457) | Biocoat, Inc. | 2006-04-13 |
| INTERMEZZO PLUS FIXTURE (K053354) | Megagen Co., Ltd. | 2006-04-13 |
| MODIFICATION TO XIA 4.5 SPINAL SYSTEM (K060748) | Stryker Spine | 2006-04-13 |
| LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING (K053589) | Bard Access Systems, Inc. | 2006-04-13 |
| GELITA-SPON ABSORBABLE GELATIN SPONGE, USP (K060878) | Curamedical, BV | 2006-04-13 |
| S2 RECON NAIL SYSTEM (K060921) | Howmedica Osteonics Corp. | 2006-04-13 |
| PROACT WITH GEL OR PROACT 1 (K052243) | Proact, Inc. | 2006-04-12 |
| INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM (K060223) | Draeger Medical Systems, Inc. | 2006-04-12 |
| CIDEX ACTIVATED DIALDEHYDE SOLUTION (K060618) | Johnson & Johnson Co. | 2006-04-12 |
| NUVASIVE SPHERX SYSTEM (K060225) | Nuvasive, Inc. | 2006-04-12 |
| MCKINLEY SATURATION CATHETER (K060119) | Mckinley Medical, LLC | 2006-04-12 |
| SYMMETRY BALLOON DILATATION CATHETER (K060959) | Boston Scientific Corporation | 2006-04-12 |
| INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS (K060039) | Draeger Medical Systems, Inc. | 2006-04-12 |
| ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICROFILL REAGENT STRIP, MODEL 7080 (K060470) | Bayer Healthcare | 2006-04-12 |
| OMNILINK .035 BILIARY STENT SYSTEM (K053459) | Guidant Corporation | 2006-04-12 |
| MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENT (K052641) | Quantum Orthopedics, Inc. | 2006-04-12 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN-0.125-8 AND CIPROFLOXACIN-0.25 - 4 UG/ML (K060217) | Becton, Dickinson & CO | 2006-04-12 |
| STRYKER PLATING SYSTEM (K060798) | Howmedica Osteonics Corp. | 2006-04-12 |