Monthly FDA 510k Decisions Database - 510ks.com

FDA 510(k) Decisions – August, 2013

  • : K123399 -
    08/01/2013 | PRECISION BIOMETRICS, INC. - MYOVISION 3.0 WIREFREE SYSTEM - 4259 23rd Ave W Ste 400 - Seattle, WA 98199
  • : K123571 -
    08/01/2013 | CARDIOMEDICAL GMBH - CARDIO VISION MICS AORTIC CLAMPS - AMSTEL 320-1 - AMSTERDAM, NOORD-HOLLAND,
  • : K130033 -
    08/01/2013 | BIOMET MANUFACTURING CORP. - TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO - 56 EAST BELL DRIVE P.O. BOX 587 - WARSAW, IN 46581 0587
  • : K130109 -
    08/01/2013 | VILLA SISTEMI MEDICALI S.P.A. - ENDOGRAPH DC - VIADELLE AZALEE, 5 - BUCCINASCO, MILANO,
  • : K130140 -
    08/01/2013 | INTRA-LOCK INTERNATIONAL - INTRA-LOCK OP DENTAL IMPLANT - 6560 WEST ROGERS CIRCLE SUITE 24 - BOCA RATON, FL 33487
  • : K130345 -
    08/01/2013 | MAYER LABORATORIES, INC. - AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING - 1950 ADDISON STREET, SUITE 101 - BERKELY, CA 94704 1182
  • : K130814 -
    08/01/2013 | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY - RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM - 325 PARAMOUNT DR. - RAYNHAM, MA 02767
  • : K130826 -
    08/01/2013 | STRYKER ENDOSCOPY - PASSPORT ROBOTIC REDUCER CAP; PASSPORT STOPCOCK WITH ROTATING MALE LUER - 5900 Optical Ct - SAN JOSE, CA 95138
  • : K131079 -
    08/01/2013 | CREGANNA MEDICAL DEVICES - CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC - 386 WEST MAIN STREET SUITE 7 - NORTHBOROUGH, MA 01532
  • : K131305 -
    08/01/2013 | CHISON MEDICAL IMAGING CO., LTD. - CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE - 7263 CRONIN CIRCLE - DUBLIN, CA 94568
  • : K121370 -
    08/02/2013 | VECTEC - VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE - 2995 STEVEN MARTIN DR. - FAIRFAX, VA 22031
  • : K122063 -
    08/02/2013 | PHILIPS ANESTHESIA CARE - INTELLISAVE AX700 ANESTHESIA SYSTEM - ISLEVDALVEJ 211 - RODOVRE,
  • : K123347 -
    08/02/2013 | NORMED MEDIZIN-TECHNIK GMBH - NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0 - 8708 CAPEHART COVE - AUSTIN, TX 78733
  • : K130933 -
    08/02/2013 | QUANTEL MEDICAL - SOLUTIS - 5 TIMBER LANE - NORTH READING, MA 01864
  • : K131166 -
    08/02/2013 | QUIDEL CORP. - SOFIA(R) HCG FIA - 10165 MCKELLAR CT. - SAN DIEGO, CA 92121
  • : K131301 -
    08/02/2013 | BECTON DICKINSON & CO. - BD FACS SAMPLE PREP ASSISTANT III - 2350 QUME DRIVE - SAN JOSE, CA 95131
  • : K131493 -
    08/02/2013 | C.R. BARD, INC. - SIDEKICK AND USHER SUPPORT CATHETERS - 1625 WEST 3RD ST. - TEMPE, AZ 85281 1740
  • : K131517 -
    08/02/2013 | MEDRAD, INC. / BAYER MEDICAL CARE, INC. - MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING - ONE MEDRAD DR. - INDIANOLA, PA 15051
  • : K132061 -
    08/02/2013 | COLOPLAST CORP. - RESTORELLE M, RESTORELLE XL - 1601 WEST RIVER - MINNEAPOLIS, MN 55411
  • : K130748 -
    08/04/2013 | SMITH & NEPHEW, INC. - SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0 - 1450 BROOKS RD. - MEMPHIS, TN 38116
  • : K122553 -
    08/05/2013 | ACON LABORATORIES, INC. - MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM - 10125 Mesa Rim Road - SAN DIEGO, CA 92121
  • : K122610 -
    08/05/2013 | SEN MU TECHNOLOGY CO., LTD. - PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES - NO. 15-2, LANE 26, MINCYUAN 1SR RD LINGYA DISTRICT - KAOHSIUNG CITY,
  • : K122883 -
    08/05/2013 | STELKAST COMPANY - EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM - 200 HIDDEN VALLEY RD. - MCMURRAY, PA 15317
  • : K130342 -
    08/05/2013 | SAUFLON PHARMACEUTICALS, LTD. - SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER - 49-53 YORK ST. - TWICKENHAM, MIDDLESEX,
  • : K130541 -
    08/05/2013 | SYMMETRY SURGICAL - SYMMETRY KERRISON DISPOSABLE TIP RONGEURS - 1927 N. ARTHUR DR. - COLUMBIA CITY, IN 46725
  • : K131286 -
    08/05/2013 | TEI BIOSCIENCES INC. - PRIMATRIX DERMAL REPAIR SCAFFOLD - 7 ELKINS ST. - BOSTON, MA 02127
  • : K131704 -
    08/05/2013 | SUN NUCLEAR CORPORATION - EPIDOSE - 3275 Suntree Blvd - Melbourne, FL 32940
  • : K131930 -
    08/05/2013 | BIOFIRE DIAGNOSTICS, INC. - JBAIDS ANTHRAX DETECTION KIT - 390 WAKARA WAY - SALT LAKE CITY, UT 84108
  • : K132190 -
    08/05/2013 | LEMAITRE VASCULAR, INC. - EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME - 63 2ND AVENUE - BURLINGTON, MA 01803
  • : K122337 -
    08/06/2013 | FERTILITY FOCUS LTD - OVUSENSE - 717 LAKEGLEN DRIVE - SUWANEE, GA 30024
  • : K123047 -
    08/06/2013 | BRACCO DIAGNOSTIC, INC. - BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET - 107 COLLEGE ROAD - PRINCETON, NJ 08540
  • : K130046 -
    08/06/2013 | CLEARSPEC LLC - CLEARSPEC SINGLE USE VAGINAL SPECULUM - 603 GRANT STREET - HERKIMER, NY 13350
  • : K130126 -
    08/06/2013 | BIOMET, INC. - SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM - 56 EAST BELL DR. - WARSAW, IN 46581 0587
  • : K130743 -
    08/06/2013 | ORTHO KINEMATICS, INC. - THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL - 555 13TH STREET NW - WASHINGTON, DC 20005 3096
  • : K131450 -
    08/06/2013 | OSTIAL CORPORATION - FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0 - 510 CLYDE AVENUE - MOUNTAIN VIEW, CA 94043
  • : K131875 -
    08/06/2013 | FORESIGHT REGULATORY STRATEGIES - MENICON NECT CONTACT LENS CASE - 187 BALLARDVALE STREET SUITE 180 - WILMINGTON, MA 01887 4461
  • : K132111 -
    08/06/2013 | MEDTRONIC SOFAMOR DANEK USA - CD HORIZON SPINAL SYSTEM - 1800 PYRAMID PLACE - MEMPHIS, TN 38132
  • : K123904 -
    08/07/2013 | MUELLER MEDICAL INTERNATIONAL LLC - PROTHELIAL - 48A MOOSUP VALLEY ROAD - FOSTER, RI 02825
  • : K130148 -
    08/07/2013 | UNITED STATES ENDOSCOPY GROUP, INC. - FOREIGN BODY HOOD - 5976 Heisley Rd - Mentor, OH 44060
  • : K130608 -
    08/07/2013 | MEDTRONIC NAVIGATION, INC. - QUADCUT - 826 COAL CREEK CIR. - LOUISVILLE, CO 80027
  • : K130932 -
    08/07/2013 | ORTHOFIX, INC. - FIREBIRD SPINAL FIXATION SYSTEM - 3451 PLANO PARKWAY - LEWISVILLE, TX 75056
  • : K131313 -
    08/07/2013 | AKTINA MEDICAL CORP. - ACTIVE BREATHING COORDINATOR - 360 NORTH ROUTE 9W - Congers, NY 10920
  • : K131345 -
    08/07/2013 | NASSEO, INC. - TIARRAY DENTAL IMPLANT SYSTEM - 12264 EL CAMINO REAL, SUITE 400 - SAN DIEGO, CA 92130
  • : K131360 -
    08/07/2013 | ASCENSION ORTHOPEDIC - INTEGRA TITANIUM BONE WEDGE - 8700 CAMERON RD., STE. 100 - Austin, TX 78754
  • : K131512 -
    08/07/2013 | SHANGHAI SANYOU MEDICAL CO, LTD - KATIA SYSTEM - 3416 ROXEE RUN COVE - BARTLETT, TN 38133
  • : K131642 -
    08/07/2013 | RSH LLC - RSH BILIARY STONE REMOVAL DEVICE - 5121 FEAGAN ST. - HOUSTON, TX 77007
  • : K131722 -
    08/07/2013 | I.T.S. GMBH - I.T.S. EXTREMITY FIXATION SYSTEMS - 3150 E. 200TH STREET - PRIOR LAKE, MN 55372
  • : K132256 -
    08/07/2013 | BECTON, DICKINSON AND COMPANY - BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B - 10865 ROAD TO THE CURE SUITE 200 - SAN DIEGO, CA 92121
  • : K132259 -
    08/07/2013 | BECTON, DICKINSON AND COMPANY - BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B - 10865 ROAD TO THE CURE SUITE 200 - SAN DIEGO, CA 92121
  • : K121610 -
    08/08/2013 | ROCHE DIAGNOSTICS OPERATIONS - COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY - 9115 Hague Rd - Indianapolis, IN 46256
By 510ks Admin on August 31, 2013 | 510(k) Decisions

510(k) Decisions