The Food & Drug Administration releases data on 510(k) clearances for medical devices it approved in April.
BARD, INC.510(k) NO: K110820(SPECIAL)ATTN: KETISINOPHONE NO : 401 825 8575100 CROSSINGS BOULEVARDSE DECISION MADE: 01-APR-11WARWICK RI 02886510(k) SUMMARY AVAILABLE FROM FDADEVICE: OSSEOTITE II MODEL XIFOSSXXXBIOMET 3I, INC.510(k) NO: K100724(TRADITIONAL)ATTN: JOSE E CABRERAPHONE NO : 561 776 68404555 RIVERSIDE DR.SE DECISION MADE: 01-APR-11PALM BEACH GARDENS FL 33410510(k) SUMMARY AVAILABLE FROM FDADEVICE: CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01CEDARS-SINAI MEDICAL CENTER510(k) NO: K100714(TRADITIONAL)ATTN: DAVID R DILLSPHONE NO : 904 519 80408787 SOUTHSIDE BLVD. #719SE DECISION MADE: 01-APR-11JACKSONVILLE FL 32256510(k) SUMMARY AVAILABLE FROM FDADEVICE: COMPRESSYN BANDDALLEN MEDICAL510(k) NO: K101484(TRADITIONAL)ATTN: ALMEMMOLOPHONE NO : 949 218 00301046 CALLE RECODO SUITE GSE DECISION MADE: 01-APR-11SAN CLEMENTE CA 92673510(k) SUMMARY AVAILABLE FROM FDADEVICE: ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEMACCLARENT, INC.510(k) NO: K103595(TRADITIONAL)ATTN: GURVINDERSINGH NANDAPHONE NO : 650 687 54141525-B O'BRIEN DR.SE DECISION MADE: 01-APR-11MENLO PARK CA 94025510(k) SUMMARY AVAILABLE FROM FDADEVICE: CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEADCONSENSUS ORTHOPEDICS, INC.510(k) NO: K110542(TRADITIONAL)ATTN: MATTHEWHULLPHONE NO : 916 355 71001115 WINDFIELD WAY, SUITE 100SE DECISION MADE: 01-APR-11EL DORADO HILLS CA 95762 9623510(k) SUMMARY AVAILABLE FROM FDADEVICE: EXPEDIUM SYSTEM, VIPER SYSTEMDEPUY SPINE, INC.510(k) NO: K110216(SPECIAL)ATTN: EUGENEBANGPHONE NO : 508 977 3966325 PARAMOUNT DR.SE DECISION MADE: 01-APR-11RAYNHAM MA 02767510(k) SUMMARY AVAILABLE FROM FDADEVICE: VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K110522(SPECIAL)ATTN: NICHOLASTABRIZIPHONE NO : 901 396 31331800 PYRAMID PLACESE DECISION MADE: 01-APR-11MEMPHIS TN 38132510(k) SUMMARY AVAILABLE FROM FDADEVICE: 1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COILGE MEDICAL SYSTEMS, LLC510(k) NO: K110610(SPECIAL)ATTN: MICHELLESCHEIDTPHONE NO : 262 521 61023200 N. GRANDVIEW BLVD.SE DECISION MADE: 01-APR-11WAUKESHA WI 53188510(k) SUMMARY AVAILABLE FROM FDADEVICE: HYLATOPICPLUS CREAMPRECISION DERMATOLOGY INCORPORATED510(k) NO: K110727(SPECIAL)ATTN: RONALD M GURGEPHONE NO : 401 762 2000900 HIGHLAND CORPORATE DRIVESE DECISION MADE: 01-APR-11CUMBERLAND RI 02864510(k) SUMMARY AVAILABLE FROM FDADEVICE: ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORSABBOT LABORATORIES510(k) NO: K102699(TRADITIONAL)ATTN: JUDITHWALLACHPHONE NO : 847 937 1132100 ABBOTT PARK RD. DEPT. 9V6 AP6CSE DECISION MADE: 01-APR-11ABBOTT PARK IL 60064 6092510(k) SUMMARY AVAILABLE FROM FDADEVICE: EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES.EXACTECH, INC.510(k) NO: K110708(SPECIAL)ATTN: LINDYKNISELYPHONE NO : 352 377 11402320 N.W. 66TH CT.SE DECISION MADE: 01-APR-11GAINESVILLE FL 32653510(k) SUMMARY AVAILABLE FROM FDADEVICE: ALYTE Y-MESH GRAFTC.R. BARD, INC.510(k) NO: K101722(TRADITIONAL)ATTN: SCOTTROBIRDSPHONE NO : 770 784 67228195 INDUSTRIAL BLVD.SE DECISION MADE: 01-APR-11COVINGTON GA 30014510(k) SUMMARY AVAILABLE FROM FDADEVICE: STERRAD SEALSURE CHEMICAL INDICATOR TAPEADVANCED STERILIZATION PRODUCTS510(k) NO: K103219(TRADITIONAL)ATTN: NANCYCHUPHONE NO : 949 453 643533 TECHNOLOGY DR.SE DECISION MADE: 01-APR-11IRVINE CA 92618510(k) SUMMARY AVAILABLE FROM FDADEVICE: STERRAD CHEMICAL INDICATOR STRIPADVANCED STERILIZATION PRODUCTS510(k) NO: K103218(TRADITIONAL)ATTN: NANCYCHUPHONE NO : 949 453 643533 TECHNOLOGY DR.SE DECISION MADE: 01-APR-11IRVINE CA 92618510(k) SUMMARY AVAILABLE FROM FDADEVICE: TORFLEX TRANSSEPTAL GUIDING SHEATHBAYLIS MEDICAL CO. INC.510(k) NO: K102948(TRADITIONAL)ATTN: MEGHALKHAKHARPHONE NO : 905 602 48752645 MATHESON BLVD. ESE DECISION MADE: 01-APR-11MISSISSAUGA, ONTARIOCA L4W 5S4510(k) SUMMARY AVAILABLE FROM FDADEVICE: THE ARTAS SYSTEM FROM RESTORATION ROBOTICSRESTORATION ROBOTICS, INC510(k) NO: K103428(TRADITIONAL)ATTN: KITCARIQUITANPHONE NO : 408 400 0856155-A MOFFETT PARK DRIVE SUITE 210SE DECISION MADE: 04-APR-11SUNNYVALE CA 94089510(k) SUMMARY AVAILABLE FROM FDADEVICE: EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENTMEDICA CORP.510(k) NO: K101088(TRADITIONAL)ATTN: PHOTIOSMAKRISPHONE NO : 781 275 48925 OAK PARK DRIVESE DECISION MADE: 04-APR-11BEDFORD MA 01730510(k) STATEMENTDEVICE: NITRILE POWDER FREE PATIENT EXAMINATION GLOVESTANGSHAN BAOJIE GLOVE CO. LTD510(k) NO: K110185(TRADITIONAL)ATTN: CHUXIAOANPHONE NO : 861 082 387441ROOM 1606 BLDG1.JIANXIANG YUAN NO.SE DECISION MADE: 04-APR-11BEIJINGCH 100083510(k) SUMMARY AVAILABLE FROM FDADEVICE: DIGITAL FOREHEAD THERMOMETERK-JUMP HEALTH CO. LTD.510(k) NO: K103617(SPECIAL)ATTN: JASONCHENGPHONE NO : 886 222 991378NO. 56, WU KUNG 5TH RD. WU KU INDSE DECISION MADE: 04-APR-11TAIPEI HSIENTW 248510(k) SUMMARY AVAILABLE FROM FDADEVICE: MODIFIED HD GUIDE CATHETERCONCENTRIC MEDICAL, INC.510(k) NO: K110483(SPECIAL)ATTN: KIRSTENVALLEYPHONE NO : 650 810 1707301 E. EVELYN AVE.SE DECISION MADE: 04-APR-11MOUNTAIN VIEW CA 94041510(k) SUMMARY AVAILABLE FROM FDADEVICE: VAULT ALIF SYSTEMSPINAL USA510(k) NO: K103369(TRADITIONAL)ATTN: LINDAPOLKPHONE NO : 601 420 42442050 EXECUTIVE DR.SE DECISION MADE: 04-APR-11PEARL MS 39208510(k) SUMMARY AVAILABLE FROM FDADEVICE: RT600RESTORATIVE THERAPIES INC.510(k) NO: K103366(TRADITIONAL)ATTN: SCOTTSIMCOXPHONE NO : 800 609 9166907 SOUTH LAKEWOOD AVE.SE DECISION MADE: 04-APR-11BALTIMORE MD 21224510(k) SUMMARY AVAILABLE FROM FDADEVICE: KNEEALIGN SYSTEMORTHALIGN, INC510(k) NO: K103829(TRADITIONAL)ATTN: AMYWALTERSPHONE NO : 949 923 9400338 VISTA MADERASE DECISION MADE: 04-APR-11NEWPORT BEACH CA 92660510(k) SUMMARY AVAILABLE FROM FDADEVICE: SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEMSOUND SURGICAL TECHNOLOGIES LLC.510(k) NO: K110255(TRADITIONAL)ATTN: STEPHEN C SMITHPHONE NO : 720 240 2970357 S. MCCASLIN BLVD. #100SE DECISION MADE: 04-APR-11LOUISVILLE CO 80027510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEWDEVICE: CARDIOHELP SYSTEMMAQUET CARDIOPULMONARY AG510(k) NO: K102726(TRADITIONAL)ATTN: ROLANDJEHLEPHONE NO : 004 974 78921373HECHINGER STRASSE 38SE DECISION MADE: 04-APR-11HIRRLINGENGM 72145510(k) SUMMARY AVAILABLE FROM FDADEVICE: BRAINLAB KNEEBRAINLAB AG510(k) NO: K102990(SPECIAL)ATTN: ALEXANDERSCHWIERSCHPHONE NO : 498 999 15680KAPELLENSTRASSE 12SE DECISION MADE: 04-APR-11FELDKIRCHENGM 85622510(k) SUMMARY AVAILABLE FROM FDADEVICE: IMPRESSION COMPOUNDSPOFADENTAL510(k) NO: K110378(TRADITIONAL)ATTN: WENDYGARMANPHONE NO : 714 516 76021717 WEST COLLINS AVENUESE DECISION MADE: 05-APR-11ORANGE CA 92867510(k) SUMMARY AVAILABLE FROM FDADEVICE: TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOMCHURCH & DWIGHT CO. INC.510(k) NO: K100767(TRADITIONAL)ATTN: JOSEPHCICCONEPHONE NO : 609 497 7251469 NORTH HARRISON STREETSE DECISION MADE: 05-APR-11PRINCETON NJ 08543510(k) SUMMARY AVAILABLE FROM FDADEVICE: AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1SALIENT SURGICAL TECHNOLOGIES510(k) NO: K101057(TRADITIONAL)ATTN: KERRIMORTONPHONE NO : 603 742 1515180 INTERNATIONAL DRIVESE DECISION MADE: 05-APR-11PORTSMOUTH NH 03801510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEWDEVICE: CUTERA GENESISPLUS LASER SYSTEMCUTERA, INC.510(k) NO: K103626(TRADITIONAL)ATTN: CONNIEHOYPHONE NO : 415 657 55923240 BAYSHORE BLVDSE DECISION MADE: 05-APR-11BRISBANE CA 94005510(k) SUMMARY AVAILABLE FROM FDADEVICE: QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEMTORNIER, INC.510(k) NO: K103262(TRADITIONAL)ATTN: HOWARD L SCHRAYERPHONE NO : 609 924 9510100 CUMMINGS CENTER SUITE 444CSE DECISION MADE: 05-APR-11BEVERLY MA 01915510(k) SUMMARY AVAILABLE FROM FDADEVICE: V60 VENTILATOR WITH PPV AND AUTO-TRAK SOFTWARE OPTIONSRESPIRONICS CALIFORNIA, INC.510(k) NO: K102985(TRADITIONAL)ATTN: TAMATHALEYPHONE NO : 760 918 10262271 COSMOS CT.SE DECISION MADE: 05-APR-11CARLSBAD CA 92011510(k) SUMMARY AVAILABLE FROM FDADEVICE: INTEGRITY SPINAL CARE SYSTEMINTEGRA LIFE SCIENCES510(k) NO: K103248(TRADITIONAL)ATTN: JAMES J GIBSONPHONE NO : 702 997 71905795 SOUTH SANDHILL ROAD SUITE F, SE DECISION MADE: 05-APR-11LAS VEGAS NV 89120510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEWDEVICE: RT200RESTORATIVE THERAPIES INC.510(k) NO: K103370(TRADITIONAL)ATTN: ANDREWBARRISKILLPHONE NO : 800 609 9166907 SOUTH LAKEWOOD AVE.SE DECISION MADE: 05-APR-11BALTIMORE MD 21224510(k) SUMMARY AVAILABLE FROM FDADEVICE: HEMOSIL LA POSITIVE CONTROLINSTRUMENTATION LABORATORY CO.510(k) NO: K102552(TRADITIONAL)ATTN: CAROLMARBLEPHONE NO : 781 861 4467180 HARTWELL ROADSE DECISION MADE: 05-APR-11BEDFORD MA 01730510(k) SUMMARY AVAILABLE FROM FDADEVICE: ESTELITE COLORTOKUYAMA DENTAL CORPORATION510(k) NO: K110178(TRADITIONAL)ATTN: KEITH A BARRITTPHONE NO : 202 783 50701425 K STREET, N.W. SUITE 1100SE DECISION MADE: 05-APR-11WASHINGTON DC 20005510(k) SUMMARY AVAILABLE FROM FDADEVICE: SHARPS CONTAINERNOBLE MARKETING510(k) NO: K110262(TRADITIONAL)ATTN: ALLISONSCOTTPHONE NO : 317 569 950011460 N. MERIDIAN ST. SUITE 150SE DECISION MADE: 05-APR-11CARMEL IN 46032510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEWDEVICE: REVERSE MEDICAL REFLEX GUIDE CATHETERREVERSE MEDICAL CORPORATION510(k) NO: K110055(TRADITIONAL)ATTN: AMYESKINAPHONE NO : 949 215 066013900 ALTON PARKWAY SUITE 123SE DECISION MADE: 05-APR-11IRVINE CA 92618510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEWDEVICE: TEMPOROMANIBULAR COIL 15ESAOTE S.P.A.510(k) NO: K110373(TRADITIONAL)ATTN: DONATELLARAGGHIANTIPHONE NO : 011 390 106547259VIA SIFFREDI 58SE DECISION MADE: 06-APR-11GENOVAIT 16153510(k) SUMMARY AVAILABLE FROM FDADEVICE: CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTORCARD GUARD SCIENTIFIC SURVIVAL LTD510(k) NO: K110499(SPECIAL)ATTN: CLAYANSELMOPHONE NO : 303 223 4303555 ZANG ST SUITE 100SE DECISION MADE: 06-APR-11LAKEWOOD CO 80228510(k) SUMMARY AVAILABLE FROM FDADEVICE: CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADESUS MEDICAL INNOVATIONS LLC510(k) NO: K100669(TRADITIONAL)ATTN: KRISTAOAKESPHONE NO : 512 327 99971705 S. CAPITAL OF TEXAS HWY SUITESE DECISION MADE: 06-APR-11AUSTIN TX 78746510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEWDEVICE: DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K100375(TRADITIONAL)ATTN: PAMELAJURGAPHONE NO : 302 631 8891PO BOX 6101 M/S 514SE DECISION MADE: 06-APR-11NEWARK DE 19714 6101510(k) SUMMARY AVAILABLE FROM FDADEVICE: ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TESTALCOPRO, INC.510(k) NO: K102225(TRADITIONAL)ATTN: PERRYRUCKERPHONE NO : 310 415 70931560 E. EDINGER AVENUE, SUITE BSE DECISION MADE: 06-APR-11SANTA ANA CA 92705510(k) SUMMARY AVAILABLE FROM FDADEVICE: HAIRMAX LASERCOMBLEXINGTON INTERNATIONAL, LLC510(k) NO: K103368(TRADITIONAL)ATTN: CASPER E ULDRIKS ESQ.PHONE NO : 202 518 63851400 SIXTEENTH STREET, NW SUITE 40SE DECISION MADE: 06-APR-11WASHINGTON DC 20036510(k) SUMMARY AVAILABLE FROM FDADEVICE: SYNGO MBFSIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K110494(SPECIAL)ATTN: ELAINECHANGPHONE NO : 847 304 75162501 NORTH BARRINGTON RD.SE DECISION MADE: 06-APR-11HOFFMAN ESTATES IL 60192510(k) SUMMARY AVAILABLE FROM FDADEVICE: ISA CO2, ISA AX , ISA OR PHASEIN AB510(k) NO: K103604(TRADITIONAL)ATTN: DAVIDWEISSBURGPHONE NO : 608 770 02234213 WINNEQUAH DR.SE DECISION MADE: 06-APR-11MADISON WI 53716510(k) SUMMARY AVAILABLE FROM FDADEVICE: PRONTOSAN WOUND IRRIGATION SOLUTIONB. BRAUN MEDICAL, INC.510(k) NO: K110744(TRADITIONAL)ATTN: NANCYSKOCYPECPHONE NO : 610 596 2796901 MARCON BLVD.SE DECISION MADE: 06-APR-11ALLENTOWN PA 18109 9341510(k) SUMMARY AVAILABLE FROM FDADEVICE: MULTIPLE BIOPSY SYSTEMUNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K103326(TRADITIONAL)ATTN: CARROLL L MARTINPHONE NO : 440 639 44945976 HEISELY RD.SE DECISION MADE: 06-APR-11MENTOR OH 44060510(k) STATEMENTDEVICE: NEWTOM 5G / NEWTOM 5G VERSION FPQR S.R.L.510(k) NO: K110260(SPECIAL)ATTN: LORENZOBORTOLOTTIPHONE NO : 390 458 202727VIA SILVESTRINI 20SE DECISION MADE: 06-APR-11VERONA, VRIT 37135510(k) SUMMARY AVAILABLE FROM FDADEVICE: RESUSCI FLOW; RESUSCI FLOW 104ATOM MEDICAL CORPORATION510(k) NO: K102542(TRADITIONAL)ATTN: PAULDRYDENPHONE NO : 239 498 215524301 WOODSTAGE DRIVESE DECISION MADE: 06-APR-11BONITA SPRINGS FL 34134510(k) SUMMARY AVAILABLE FROM FDADEVICE: VELA XLSTARMEDTEC GMBH510(k) NO: K103654(TRADITIONAL)ATTN: GREGORWEIDEMANNPHONE NO : 498 151 268610KREUZSTRASSE 22SE DECISION MADE: 06-APR-11STARNBERGGM 82319510(k) SUMMARY AVAILABLE FROM FDADEVICE: MICROLIFE DIGITAL UNDERARM THERMOMETERMICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K103680(TRADITIONAL)ATTN: SUSAN D GOLDSTEIN-FALKPHONE NO : 949 706 745655 NORTHERN BOULEVARD SUITE 200SE DECISION MADE: 06-APR-11GREAT NECK NY 10021510(k) SUMMARY AVAILABLE FROM FDADEVICE: DISPOSABLE BLLOD COLLECTION NEEDLEWEIHAI HONGYU MEDICAL DEVICES CO.510(k) NO: K103587(TRADITIONAL)ATTN: DIANAHONGPHONE NO : 862 164 264467P.O. BOX 237-023SE DECISION MADE: 06-APR-11SHANGHAICH 264200510(k) SUMMARY AVAILABLE FROM FDADEVICE: DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON HSIEMENS HEALTHCARE DIAGNOSTICS510(k) NO: K110169(TRADITIONAL)ATTN: KATHLEEN ANNDRAY-LYONSPHONE NO : 781 826 4551500 GBC DRIVE PO BOX 6101SE DECISION MADE: 07-APR-11NEWARK DE 19714510(k) SUMMARY AVAILABLE FROM FDADEVICE: ACCULIF CAGECOALIGN INNOVATIONS, INC.510(k) NO: K110270(SPECIAL)ATTN: JUSTINEGGLETONPHONE NO : 202 552 58001331 H STREET NW 12TH FLOORSE DECISION MADE: 07-APR-11WASHINGTON DC 20005510(k) SUMMARY AVAILABLE FROM FDADEVICE: XPERT C. DIFFICLE/EPI ASSAYCEPHEID510(k) NO: K110203(TRADITIONAL)ATTN: RUSSEL K ENNSPHONE NO : 408 400 8230904 CARIBBEAN DRIVESE DECISION MADE: 07-APR-11SUNNYVALE CA 94089 1189510(k) SUMMARY AVAILABLE FROM FDADEVICE: MOUNTAINEER OCT SPINAL SYSTEMDEPUY SPINE, INC.510(k) NO: K110353(SPECIAL)ATTN: LUKEBULINOPHONE NO : 508 828 3267325 PARAMOUNT DR.SE DECISION MADE: 07-APR-11RAYNHAM MA 02767510(k) SUMMARY AVAILABLE FROM FDADEVICE: XVACSORIN GROUP Italia S.R.L.510(k) NO: K110782(TRADITIONAL)ATTN: BARRYSALLPHONE NO : 781 434 4742195 WEST STREETSE DECISION MADE: 07-APR-11WALTHAM MA 02451510(k) SUMMARY AVAILABLE FROM FDADEVICE: SYNAPSE 3D LIVER ANALYSISFUJIFILM MEDICAL SYSTEM U.S.A. IN510(k) NO: K110186(TRADITIONAL)ATTN: KIMERLY A SHARPPHONE NO : 203 602 3665419 WEST AVE.SE DECISION MADE: 07-APR-11STAMFORD CT 06902 6300510(k) SUMMARY AVAILABLE FROM FDADEVICE: EMS AIR-FLOW MASTER PIEZONEMS ELECTRO MEDICAL SYSTEMS SA510(k) NO: K110173(TRADITIONAL)ATTN: CYNTHIA J M. NOLTE, PH.D, RAPHONE NO : 919 859 420749 PLAIN ST.SE DECISION MADE: 07-APR-11NORTH ATTLEBORO MA 02760510(k) SUMMARY AVAILABLE FROM FDADEVICE: COMBITRANS MONITORING SETS AND ACCESSORIESB. BRAUN MELSUNGEN AG510(k) NO: K102033(ABBREVIATED)ATTN: LISAGIAQUINTOPHONE NO : 610 596 2354901 MARCON BLVDSE DECISION MADE: 07-APR-11ALLENTOWN PA 18109510(k) SUMMARY AVAILABLE FROM FDADEVICE: 4D SONO-SCAN 1.0TOMTEC IMAGING SYSTEMS, GMBH510(k) NO: K110595(TRADITIONAL)ATTN: INGESCHEIDTPHONE NO : 498 932 175515EDISONSTRASSE 6SE DECISION MADE: 07-APR-11UNTERSCHLEISSHEIMGM D-85716510(k) SUMMARY AVAILABLE FROM FDADEVICE: UNI-VENT 731 SERIES MODEL EMV PORTABLE CRITICAL CARE VENTILATORIMPACT INSTRUMENTATION, INC.510(k) NO: K103318(TRADITIONAL)ATTN: SUSANMCNEVINPHONE NO : 973 882 121227 FAIRFIELD PL. P.O. BOX 508SE DECISION MADE: 07-APR-11WEST CALDWELL NJ 07006 0508510(k) SUMMARY AVAILABLE FROM FDADEVICE: UTA AND UHAUTA510(k) NO: K102467(TRADITIONAL)ATTN: ANGELABLACKWELLPHONE NO : 704 450 99343318 SUCCESFUL WAYSE DECISION MADE: 07-APR-11DAYTON OH 45414510(k) SUMMARY AVAILABLE FROM FDADEVICE: CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SETRANDOX LABORATORIES, LTD.510(k) NO: K092269(TRADITIONAL)ATTN: PARMSTRONGPHONE NO : 440 289 442241355 DIAMOND RD.SE DECISION MADE: 08-APR-11CRUMLIN, COUNTY ANTRIMUK BT29 510(k) STATEMENTDEVICE: INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000INTUITIVE SURGICAL, INC.510(k) NO: K101581(TRADITIONAL)ATTN: BRANDONHANSENPHONE NO : 408 523 21001266 KIFER ROADSE DECISION MADE: 08-APR-11SUNNYVALE CA 94086 5206510(k) SUMMARY AVAILABLE FROM FDADEVICE: PRELUDE III TONGUE SUSPENSION SYSTEMSIESTA MEDICAL, INC.510(k) NO: K110127(SPECIAL)ATTN: MICHAELKOLBERPHONE NO : 408 505 6626101 CHURCH STREET SUITE 3SE DECISION MADE: 08-APR-11LOS GATOS CA 95030510(k) SUMMARY AVAILABLE FROM FDADEVICE: AGILIS ES STEERABLE INTRODUCERST. JUDE MEDICAL510(k) NO: K103083(TRADITIONAL)ATTN: LAURAMOEN-FTACEKPHONE NO : 651 756 295714901 DEVEAU PLACESE DECISION MADE: 08-APR-11MINNETONKA MN 55345 2126510(k) SUMMARY AVAILABLE FROM FDADEVICE: PAIRED HYDROGEL ELECTRODENEUROVISION MEDICAL PRODUCTS, INC.510(k) NO: K110138(SPECIAL)ATTN: CHRISTINEVERGELYPHONE NO : 805 866 69992225 SPERRY AVE, SUITE 1000SE DECISION MADE: 08-APR-11VENTURA CA 93003510(k) SUMMARY AVAILABLE FROM FDADEVICE: ACUITY WHISPER VIEW GUIDE WIRESBOSTON SCIENTIFIC CORP.510(k) NO: K110479(SPECIAL)ATTN: KIRSTINJOHNSTONPHONE NO : 651 582 58714100 HAMLINE AVE NORTH MS 9-330SE DECISION MADE: 08-APR-11ST. PAUL MN 55112510(k) SUMMARY AVAILABLE FROM FDADEVICE: REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SETETHICON ENDO-SURGERY, LLC510(k) NO: K103672(TRADITIONAL)ATTN: DENNISHAHNPHONE NO : 513 337 31344545 CREEK ROADSE DECISION MADE: 08-APR-11CINCINNATI OH 45242510(k) SUMMARY AVAILABLE FROM FDADEVICE: PORTABLE X-RAY SYSTEMDIGIMED CORPORATION510(k) NO: K103600(TRADITIONAL)ATTN: KIMANTOLPHONE NO : 847 419 06691607 N. BARCLAY AVE.SE DECISION MADE: 08-APR-11BUFFALO GROVE IL 60089510(k) SUMMARY AVAILABLE FROM FDADEVICE: PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIPTHERAPEUTICS 101, INC (DBA PRESSUR510(k) NO: K110563(TRADITIONAL)ATTN: JULIEPOWELLPHONE NO : 269 720 1329611 WEST 5TH STREET THIRD FLOORSE DECISION MADE: 08-APR-11AUSTIN TX 78701510(k) SUMMARY AVAILABLE FROM FDADEVICE: ULTIMATE VIT ENHAMCER (UVE)MEDICAL INSTRUMENT DEVELOPMENT LAB510(k) NO: K102222(TRADITIONAL)ATTN: LINDAUPTONPHONE NO : 510 357 3952557 MC CORMICK STREETSE DECISION MADE: 08-APR-11SAN LEANDRO CA 94577510(k) SUMMARY AVAILABLE FROM FDADEVICE: IMAGE-ARENA AND IMAGE-ARENA APPLICATIONSTOMTEC IMAGING SYSTEMS, GMBH510(k) NO: K110667(TRADITIONAL)ATTN: INGESCHEIDTPHONE NO : 498 932 175515EDISONSTRASSE 6SE DECISION MADE: 08-APR-11UNTERSCHLEISSHEIMGM D-85716510(k) SUMMARY AVAILABLE FROM FDADEVICE: ACAM 5 AUDIOMETER SYSTEMACOUSTICON GMBH510(k) NO: K103298(TRADITIONAL)ATTN: MAUREENGARNERPHONE NO : 732 779 74221983 HAZELWOOD ROADSE DECISION MADE: 08-APR-11TOMS RIVER NJ 08754510(k) SUMMARY AVAILABLE FROM FDADEVICE: THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAYMICROGENICS CORP.510(k) NO: K101742(TRADITIONAL)ATTN: LISACHARTERPHONE NO : 510 979 514246360 FREMONT BLVDSE DECISION MADE: 08-APR-11FREMONT CA 94538510(k) SUMMARY AVAILABLE FROM FDADEVICE: THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAYMICROGENICS CORP.510(k) NO: K101744(TRADITIONAL)ATTN: LISACHARTERPHONE NO : 510 979 514246360 FREMONT BLVDSE DECISION MADE: 08-APR-11FREMONT CA 94538510(k) SUMMARY AVAILABLE FROM FDADEVICE: THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAYMICROGENICS CORP.510(k) NO: K101745(TRADITIONAL)ATTN: LISACHARTERPHONE NO : 510 979 514246360 FREMONT BLVDSE DECISION MADE: 08-APR-11FREMONT CA 94538510(k) SUMMARY AVAILABLE FROM FDADEVICE: THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAYMICROGENICS CORP.510(k) NO: K101746(TRADITIONAL)ATTN: LISACHARTERPHONE NO : 510 979 514246360 FREMONT BLVDSE DECISION MADE: 08-APR-11FREMONT CA 94538510(k) SUMMARY AVAILABLE FROM FDADEVICE: XEROS DRY MOUTH PUMPLORIN TECHNOLOGIES CORPORATION510(k) NO: K110116(TRADITIONAL)ATTN: ALTOMANPHONE NO : 919 341 4128436 WOODLAND DRSE DECISION MADE: 08-APR-11SWANSBORO NC 28584510(k) SUMMARY AVAILABLE FROM FDADEVICE: A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE COILS 18ESAOTE S.P.A.510(k) NO: K110802(SPECIAL)ATTN: ALLISONSCOTTPHONE NO : 317 569 950011460 N MERIDIAN ST SUITE 150SE DECISION MADE: 08-APR-11CARMEL IN 46032510(k) SUMMARY AVAILABLE FROM FDADEVICE: NICOLET WIRELESS EEGCAREFUSION 209, INC.510(k) NO: K103140(TRADITIONAL)ATTN: ROBERTBURDGEPHONE NO : 608 829 86551850 Deming WaySE DECISION MADE: 08-APR-11Middleton WI 53562510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEWDEVICE: HYDROFIX VASO SHIELDMIMEDX GROUP, INC510(k) NO: K101805(TRADITIONAL)ATTN: SALLYTHORSENPHONE NO : 678 384 6720811 LIVINGSTON COURT SE SUITE BSE DECISION MADE: 08-APR-11MARIETTA GA 30067510(k) SUMMARY AVAILABLE FROM FDADEVICE: THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORSMICROGENICS CORP.510(k) NO: K101752(TRADITIONAL)ATTN: LISACHARTERPHONE NO : 510 979 514246360 FREMONT BLVDSE DECISION MADE: 08-APR-11FREMONT CA 94538510(k) SUMMARY AVAILABLE FROM FDADEVICE: THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAYMICROGENICS CORP.510(k) NO: K101753(TRADITIONAL)ATTN: LISACHARTERPHONE NO : 510 979 514246360 FREMONT BLVDSE DECISION MADE: 08-APR-11FREMONT CA 94538510(k) SUMMARY AVAILABLE FROM FDADEVICE: THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAYMICROGENICS CORP.510(k) NO: K101754(TRADITIONAL)ATTN: LISACHARTERPHONE NO : 510 979 514246360 FREMONT BLVDSE DECISION MADE: 08-APR-11FREMONT CA 94538510(k) SUMMARY AVAILABLE FROM FDADEVICE: TAKE 1 ADVANCED RIGID TRAYKERR CORPORATION510(k) NO: K110092(TRADITIONAL)ATTN: WENDYGARMANPHONE NO : 714 516 76021717 WEST COLLINS AVE.SE DECISION MADE: 08-APR-11ORANGE CA 92867510(k) SUMMARY AVAILABLE FROM FDADEVICE: UF-760AGFUKUDA DENSHI CO. LTD.510(k) NO: K110920(TRADITIONAL)ATTN: LORANVAN NOYPHONE NO : 425 881 773717725 N.E. 65TH STREET BLDG CSE DECISION MADE: 08-APR-11REDMOND WA 98052 4911510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEWDEVICE: AMBIT TUNNELERSUMMIT MEDICAL PRODUCTS, INC510(k) NO: K110814(ABBREVIATED)ATTN: MARKO V AMENPHONE NO : 801 214 34642480 SOUTH Main STREET #212SE DECISION MADE: 08-APR-11SALT LAKE CITY UT 84118510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEWDEVICE: APEX ER. YAG / IPL SYSTEMSANDSTONE MEDICAL TECHNOLOGIES LLC510(k) NO: K110304(TRADITIONAL)ATTN: MARKROHRERPHONE NO : 205 290 8251105 CITATION COURTSE DECISION MADE: 08-APR-11BIRMINGHAM AL 35209510(k) SUMMARY AVAILABLE FROM FDADEVICE: SCENARIA WHOLE-BODY X-RAY CT SYSTEMHITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K101888(TRADITIONAL)ATTN: DOUGTHISTLETHWAITEPHONE NO : 330 425 13131959 SUMMIT COMMERCE PARKSE DECISION MADE: 08-APR-11TWINSBURG OH 44087510(k) SUMMARY AVAILABLE FROM FDADEVICE: ATRICURE BIPOLAR SYSTEMATRICURE, INC.510(k) NO: K110117(TRADITIONAL)ATTN: JAMESLUCKY, RACPHONE NO : 513 755 57546217 CENTER PARK DRIVESE DECISION MADE: 08-APR-11WEST CHESTER OH 45069510(k) SUMMARY AVAILABLE FROM FDADEVICE: ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANTASTRA TECH, INC.510(k) NO: K103759(TRADITIONAL)ATTN: BETSY A BROWNPHONE NO : 847 560 44068944 TAMAROA TERR.SE DECISION MADE: 08-APR-11SKOKIE IL 60076510(k) SUMMARY AVAILABLE FROM FDADEVICE: SMITH & NEWPHEW ULTRABRAID II SUTURESMITH & NEWPHEW, INC510(k) NO: K101377(TRADITIONAL)ATTN: CHRISTINAFLORESPHONE NO : 508 261 3705150 MINUTEMAND ROADSE DECISION MADE: 08-APR-11ANDOVER MA 01810510(k) SUMMARY AVAILABLE FROM FDADEVICE: DENOVO TEDDY GEL INFANT HEEL WARMERDENOVO PRODUCTS LLC510(k) NO: K103549(TRADITIONAL)ATTN: DALEWALTERSPHONE NO : 239 245 703017051 Alico Commerce Court Unit 3 SE DECISION MADE: 08-APR-11Fort Myers FL 33967510(k) STATEMENTDEVICE: LP CAGEMEDYSSEY CO. LTD.510(k) NO: K110067(TRADITIONAL)ATTN: RICHJANSENPHONE NO : 612 281 550513540 GUILD AVESE DECISION MADE: 08-APR-11APPLE VALLEY MN 55124510(k) SUMMARY AVAILABLE FROM FDADEVICE: ATAMA SYSTEMMONTERIS MEDICAL, INC.510(k) NO: K110411(TRADITIONAL)ATTN: JEFFWILSONPHONE NO : 204 272 2220100 - 78 Innovation DriveSE DECISION MADE: 08-APR-11WinnipegCA R3T 6C2510(k) SUMMARY AVAILABLE FROM FDADEVICE: D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVERVASCULAR SOLUTIONS, INC.510(k) NO: K102212(TRADITIONAL)ATTN: LISAGALLATINPHONE NO : 763 656 43996464 SYCAMORE COURTSE DECISION MADE: 08-APR-11MINNEAPOLIS MN 55369510(k) SUMMARY AVAILABLE FROM FDADEVICE: TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITEHOWMEDICA OSTEONICS CORP510(k) NO: K101072(TRADITIONAL)ATTN: KARENARIEMMAPHONE NO : 201 831 5718325 CORPORATE DR.SE DECISION MADE: 11-APR-11MAHWAH NJ 07430510(k) SUMMARY AVAILABLE FROM FDADEVICE: LATARJET CORTICAL SCREW SETT.A.G. MEDICAL PRODUCTS CORPORATIO510(k) NO: K110763(SPECIAL)ATTN: GEORGE J HATTUBPHONE NO : 508 479 6116291 HILLSIDE AVENUESE DECISION MADE: 11-APR-11SOMERSET MA 02726510(k) SUMMARY AVAILABLE FROM FDADEVICE: TAPER OXINIUM FEMORAL HEADSMITH & NEPHEW, INC.510(k) NO: K110101(TRADITIONAL)ATTN: SHEREENMYERSPHONE NO : 901 396 21211450 EAST BROOKS RD.SE DECISION MADE: 11-APR-11MEMPHIS TN 38116510(k) SUMMARY AVAILABLE FROM FDADEVICE: AMC-20 PORTABLE DENTAL CART MODEL AMC-20ASEPTICO, INC.510(k) NO: K101332(TRADITIONAL)ATTN: CHERIE A TREGONINGPHONE NO : 425 487 31578333 216TH ST. S.E.SE DECISION MADE: 11-APR-11WOODINVILLE WA 98072510(k) STATEMENTDEVICE: DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604SIEMENS HEALTHCARE DIAGNOSTICS510(k) NO: K100321(TRADITIONAL)ATTN: ROSEMARINELLIPHONE NO : 302 631 8805MS 514, PO BOX 6101SE DECISION MADE: 12-APR-11NEWARK DE 19714 6101510(k) SUMMARY AVAILABLE FROM FDADEVICE: SYNGO.CT CARDIAC FUNCTIONSIEMENS AG510(k) NO: K110366(TRADITIONAL)ATTN: RALFHOFFMANNPHONE NO :51 VALLEY STREAM PKWYSE DECISION MADE: 12-APR-11MALVERN PA 19355510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEWDEVICE: PROPEP DELIVERY DEVICERHYTHMLINK INTERNATIONAL, LLC510(k) NO: K103200(TRADITIONAL)ATTN: JAMES M MEWBORNEPHONE NO : 803 252 12221140 FIRST STREET SOUTHSE DECISION MADE: 12-APR-11COLUMBIA SC 29209510(k) SUMMARY AVAILABLE FROM FDADEVICE: INFUSION ADAPTER C100CARMEL PHARMA AB.510(k) NO: K110023(TRADITIONAL)ATTN: KJELLANDREASSONPHONE NO : 463 170 30400AMINOGATAN 30SE DECISION MADE: 12-APR-11MOLNDALSW S431 53510(k) SUMMARY AVAILABLE FROM FDADEVICE: CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050CORELEADER BIOTECH CO. LTD.510(k) NO: K102943(TRADITIONAL)ATTN: IANLIPHONE NO : 886 269 6888019F NO. 100, SEC 1 SINTAI 5TH RD, SE DECISION MADE: 12-APR-11TAIPEI, TAIWANTW 22102510(k) SUMMARY AVAILABLE FROM FDADEVICE: WALDO PATIENT MONITORWALDO HEALTH510(k) NO: K110334(TRADITIONAL)ATTN: ALAN R WEISSPHONE NO : 512 219 03024505 SPICEWOOD SPRINGS ROAD, SUITESE DECISION MADE: 12-APR-11AUSTIN TX 78759510(k) SUMMARY AVAILABLE FROM FDADEVICE: MEDVOXEL HEARTPRO SOFTWARE APPLICATIONMEDVOXEL SYSTEMS INC510(k) NO: K103565(TRADITIONAL)ATTN: BONNIESEWLOCHANPHONE NO : 647 234 66432867 CROSSCURRENT DRIVESE DECISION MADE: 12-APR-11MISSISSAUGACA L5N 6L1510(k) SUMMARY AVAILABLE FROM FDADEVICE: STRAIGHT ABUTMENT, 4.2, 4.6, 5. 6.4, IMPLANT 6. IMPLANT 7. IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064,KAT IMPLANTS, LLC510(k) NO: K101201(TRADITIONAL)ATTN: VITALIBONDARPHONE NO : 603 427 008415 RYE STREET SUITE 115SE DECISION MADE: 13-APR-11PORTSMOUTH NH 03801510(k) SUMMARY AVAILABLE FROM FDADEVICE: EVA TPN BAGVALMED S.R.L.510(k) NO: K101412(TRADITIONAL)ATTN: WALTERSVANOSIOPHONE NO : 390 342 052382VIA PROVINCIALE 10SE DECISION MADE: 13-APR-11MAZZO DI VALTELLINA SOIT I 230510(k) SUMMARY AVAILABLE FROM FDADEVICE: MPS450 MULTIPARAMETER SIMULATORFLUKE BIOMEDICAL510(k) NO: K103336(TRADITIONAL)ATTN: JOHNNELSONPHONE NO : 440 498 25796045 COCHRAN RD.SE DECISION MADE: 13-APR-11SOLON OH 44139510(k) SUMMARY AVAILABLE FROM FDADEVICE: ONESTEP ADULT MULTI-FUNCTION ELECTRODEZOLL MEDICAL CORPORATION510(k) NO: K110742(SPECIAL)ATTN: ROBERTMORSEPHONE NO : 866 639 0060525 NARRAGANSETT PARK DRIVESE DECISION MADE: 13-APR-11PAWTUCKET RI 02861510(k) SUMMARY AVAILABLE FROM FDADEVICE: DBX DEMINERALIZED BONE MATRIX PUTTYMUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K103795(TRADITIONAL)ATTN: NANCYJOYPHONE NO : 732 661 2381125 MAY STREETSE DECISION MADE: 13-APR-11EDISON NJ 08837510(k) SUMMARY AVAILABLE FROM FDADEVICE: DBX DEMINERALIZED BONE MATRIX PUTTYMUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K103784(TRADITIONAL)ATTN: NANCYJOYPHONE NO : 732 661 2381125 MAY STREETSE DECISION MADE: 13-APR-11EDISON NJ 08837510(k) SUMMARY AVAILABLE FROM FDADEVICE: ARCHITEX SPACE MAINTENANCE SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K110259(TRADITIONAL)ATTN: KELLYDAVIDSONPHONE NO : 901 399 30351800 PYRAMID PLACESE DECISION MADE: 13-APR-11MEMPHIS TN 38132510(k) SUMMARY AVAILABLE FROM FDADEVICE: ODRC-DYNAMIC HIP SCREW SYSTEMORTHOPAEDIC DEVICE RESEARCH CENTER510(k) NO: K103015(TRADITIONAL)ATTN: CHENG-KUNGCHENGPHONE NO : 886 228 267020NO. 155, SEC. 2 LI-NUNG STREETSE DECISION MADE: 13-APR-11TAIPEITW 112510(k) SUMMARY AVAILABLE FROM FDADEVICE: IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE)IVOCLAR VIVADENT, INC.510(k) NO: K103556(TRADITIONAL)ATTN: DONNA MARIEHARTNETTPHONE NO : 716 691 0010175 PINEVIEW DR.SE DECISION MADE: 13-APR-11AMHERST NY 14228510(k) STATEMENTDEVICE: NEWDEAL COMPRESSION PLATESNEWDEAL SAS510(k) NO: K093914(TRADITIONAL)ATTN: STEPHENBEIERPHONE NO : 609 936 5436311 ENTERPRISE DR.SE DECISION MADE: 14-APR-11PLAINSBORO NJ 08536510(k) SUMMARY AVAILABLE FROM FDADEVICE: 3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE3M COMPANY CORP510(k) NO: K101468(TRADITIONAL)ATTN: LINDAJOHNSONPHONE NO : 651 737 43763M CENTER, BLDG 275-5W-06SE DECISION MADE: 14-APR-11ST. PAUL MN 55144 1000510(k) SUMMARY AVAILABLE FROM FDADEVICE: KELYNIAM CUSTOM SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC510(k) NO: K103582(TRADITIONAL)ATTN: JAMESKETNERPHONE NO : 860 832 9331200 MYRTLE STREET 2ND FLOORSE DECISION MADE: 14-APR-11NEW BRITAIN CT 06053510(k) SUMMARY AVAILABLE FROM FDADEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)SHIJIAZHUANG GLORY PLASTIC CO. LT510(k) NO: K102085(TRADITIONAL)ATTN: CHUXIAOANPHONE NO : 86 10 82387441# 209 BEI SI HUAN ZHONG ROAD RM 16SE DECISION MADE: 14-APR-11BEIJINGCH 100083510(k) SUMMARY AVAILABLE FROM FDADEVICE: VICOR PD2I ANALYZERVICOR TECHNOLOGIES, INC.510(k) NO: K101867(TRADITIONAL)ATTN: GLENPARKPHONE NO : 212 681 2100261 MADISON AVE. 24TH FLOORSE DECISION MADE: 14-APR-11NEW YORK NY 10016510(k) SUMMARY AVAILABLE FROM FDADEVICE: SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1SMITH & NEPHEW, INC.510(k) NO: K110240(SPECIAL)ATTN: SHEREENMYERSPHONE NO : 901 399 63251450 EAST BROOKS RD.SE DECISION MADE: 14-APR-11MEMPHIS TN 38116510(k) SUMMARY AVAILABLE FROM FDADEVICE: NOVABONE PUTTY - BIOACTIVE SYNTHETIC BONE GRAFTNOVABONE PRODUCTS, LLC510(k) NO: K110368(SPECIAL)ATTN: DAVID M GAISSERPHONE NO : 386 462 766113631 PROGRESS BLVD SUITE 600SE DECISION MADE: 14-APR-11ALACHUA FL 32615510(k) SUMMARY AVAILABLE FROM FDADEVICE: INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETERBOSTON SCIENTIFIC CORPORATION510(k) NO: K110887(SPECIAL)ATTN: ASHLEYPYLEPHONE NO : 508 683 4359100 BOSTON SCIENTIFIC WAYSE DECISION MADE: 14-APR-11MARLBOROUGH MA 01752510(k) SUMMARY AVAILABLE FROM FDADEVICE: EVERCROSS 0.035" OTW PTA DILATATION CATHETEREV3 INC510(k) NO: K110319(SPECIAL)ATTN: PAULACORDEROPHONE NO : 763 398 73443033 CAMPUS DRIVESE DECISION MADE: 14-APR-11PLYMOUTH MN 55441510(k) SUMMARY AVAILABLE FROM FDADEVICE: APNEA RISK EVALUATION SYSTEM (ARES)ADVANCED BRAIN MONITORING INC.510(k) NO: K110705(SPECIAL)ATTN: ADRIENNELENZPHONE NO : 262 290 00232511 FOX RIVER CIRCLESE DECISION MADE: 14-APR-11WAUKESHA WI 53189510(k) SUMMARY AVAILABLE FROM FDADEVICE: DISPOSABLE ENDOMETRIAL SUCTION CURETTEJIANGSU SUYUN MEDICAL MATERIALS CO510(k) NO: K102847(TRADITIONAL)ATTN: DIANAHONGPHONE NO : 862 164 264467P.O. BOX 237-023SE DECISION MADE: 14-APR-11SHANGHAICH 200237510(k) SUMMARY AVAILABLE FROM FDADEVICE: OPTERTRAK LOGIC PSC TIBIAL INSERTEXACTECH SARASOTA510(k) NO: K110547(SPECIAL)ATTN: PATRICKHUGHESPHONE NO : 352 377 11402320 NW 66TH COURTSE DECISION MADE: 14-APR-11GAINESVILLE FL 32653510(k) SUMMARY AVAILABLE FROM FDADEVICE: REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEMREVERSE MEDICAL CORPORATION510(k) NO: K102418(TRADITIONAL)ATTN: AMYESKINAPHONE NO : 949 215 060013900 ALTON PARKWAY SUITE 123SE DECISION MADE: 15-APR-11IRVINE CA 92618510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEWDEVICE: MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZERTANITA CORP.510(k) NO: K100183(TRADITIONAL)ATTN: TOSHISHIKOISHIKAWAPHONE NO : 847 640 92412625 SOUTH CLEARBROOK DRIVESE DECISION MADE: 15-APR-11ARLINGTON HEIGHTS IL 60005510(k) SUMMARY AVAILABLE FROM FDADEVICE: LANX SPINAL FIXATION SYSTEMLANX, INC.510(k) NO: K103091(SPECIAL)ATTN: ANDREWLAMBORNEPHONE NO : 303 443 7500390 INTERLOCKEN CRESCENT SUITE 890SE DECISION MADE: 15-APR-11BROOMFIELD CO 80021510(k) SUMMARY AVAILABLE FROM FDADEVICE: ANGIOSCULPT PTA SCORING BALLOON CATHETERANGIOSCORE, INC.510(k) NO: K110767(SPECIAL)ATTN: JONATHAN S KAHANPHONE NO : 202 637 5794555 THIRTEENTH STREET NWSE DECISION MADE: 15-APR-11WASHINGTON DC 20004510(k) SUMMARY AVAILABLE FROM FDADEVICE: AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOXINTERNATIONAL BIOMEDICAL, LTD.510(k) NO: K103527(SPECIAL)ATTN: AMYPIEPERPHONE NO : 512 873 00338508 CROSS PARK DR.SE DECISION MADE: 15-APR-11AUSTIN TX 78754510(k) SUMMARY AVAILABLE FROM FDADEVICE: VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOXINTERNATIONAL BIOMEDICAL, LTD.510(k) NO: K103524(SPECIAL)ATTN: AMYPIEPERPHONE NO : 512 873 00338508 CROSS PARK DR.SE DECISION MADE: 15-APR-11AUSTIN TX 78754510(k) SUMMARY AVAILABLE FROM FDADEVICE: DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED ARRAY TRANSDUCERSHANTOU I NSTITUTE OF ULTRASONIC I510(k) NO: K110841(SPECIAL)ATTN: FLOWERCAIPHONE NO : 867 548 825015077 JINSHA ROADSE DECISION MADE: 15-APR-11SHANTOU, GUANGDONGCH 515041510(k) SUMMARY AVAILABLE FROM FDADEVICE: SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORSSPSMEDICAL SUPPLY CORP.510(k) NO: K110152(TRADITIONAL)ATTN: GARY J SOCOLAPHONE NO : 585 359 01306789 WEST HENRIETTA RDSE DECISION MADE: 15-APR-11RUSH NY 14543510(k) SUMMARY AVAILABLE FROM FDADEVICE: NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGSCARDINAL HEALTH, INC.510(k) NO: K110921(TRADITIONAL)ATTN: TATYANABOGDANPHONE NO : 847 887 23251430 WAUKEGAN ROADSE DECISION MADE: 15-APR-11MCGAW PARK IL 60085510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEWDEVICE: ATMOS E 201 THORAX AND ATMOS S 201 THORAXATMOS INC.510(k) NO: K103042(TRADITIONAL)ATTN: MARCOSCHLEGELPHONE NO : 610 740 10113717 HUCKLEBERRY ROADSE DECISION MADE: 15-APR-11ALLENTOWN PA 18104510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEWDEVICE: CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS; LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LIZIMMER, INC.510(k) NO: K103662(SPECIAL)ATTN: REBECCABROOKSPHONE NO : 574 371 8033P.O. BOX 708SE DECISION MADE: 15-APR-11WARSAW IN 46581 0708510(k) SUMMARY AVAILABLE FROM FDADEVICE: ARTISTE SOLUTION WITH SYS_VB50 UPDATESIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K103606(TRADITIONAL)ATTN: CHRISTINEDUNBARPHONE NO : 925 602 81574040 NELSON AVE.SE DECISION MADE: 15-APR-11CONCORD CA 94520510(k) SUMMARY AVAILABLE FROM FDADEVICE: DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605SIEMENS HEALTHCARE DIAGNOSTICS510(k) NO: K100344(TRADITIONAL)ATTN: ROSEMARINELLIPHONE NO : 302 631 8805MS 514, PO BOX 6101SE DECISION MADE: 18-APR-11NEWARK DE 19714 6101510(k) SUMMARY AVAILABLE FROM FDADEVICE: INFILL INTERVERTEBRAL BODY FUSION DEVICEPINNACLE SPINE GROUP, LLC510(k) NO: K103729(TRADITIONAL)ATTN: REBECCA K PINEPHONE NO : 760 809 51781601 ELM STREET, SUITE 300SE DECISION MADE: 18-APR-11DALLAS TX 75201510(k) SUMMARY AVAILABLE FROM FDADEVICE: AOI CRANIAL HELMETADVANCED ORTHOPRO INC.510(k) NO: K103362(TRADITIONAL)ATTN: MOHAMADMANSOORIPHONE NO : 317 924 44441820 N. ILLINOIS ST.SE DECISION MADE: 18-APR-11INDIANAPOLIS IN 46202510(k) SUMMARY AVAILABLE FROM FDADEVICE: RESPICHAMBER VALVED HOLDING CHAMBERTRUDELL MEDICAL INTL.510(k) NO: K110136(TRADITIONAL)ATTN: DARRYLFISHERPHONE NO : 519 455 7060725 THIRD ST.SE DECISION MADE: 18-APR-11LONDON, ONTARIOCA N5V 5G4510(k) SUMMARY AVAILABLE FROM FDADEVICE: DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMSGE MEDICAL SYSTEMS, LLC510(k) NO: K093581(TRADITIONAL)ATTN: TRACEYORTIZPHONE NO : 414 544 30263000 N GRANDVIEW BLVD.SE DECISION MADE: 19-APR-11WAUKESHA WI 53188510(k) SUMMARY AVAILABLE FROM FDADEVICE: WEXLER VASCULAR CLAMP SERIESMICROSURGICAL LABORATORIES,INC.DBA510(k) NO: K110148(TRADITIONAL)ATTN: LISA S JONESPHONE NO : 713 664 6775540 COLLEGE STREETSE DECISION MADE: 19-APR-11BELLAIRE TX 77401510(k) SUMMARY AVAILABLE FROM FDADEVICE: CONSERVE BIO FOAM SHELLWRIGHT MEDICAL TECHNOLOGY, INC.510(k) NO: K110029(TRADITIONAL)ATTN: DANIELLEMUELLERPHONE NO : 901 290 59045677 AIRLINE ROADSE DECISION MADE: 19-APR-11ARLINGTON TN 38002510(k) SUMMARY AVAILABLE FROM FDADEVICE: INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HAJIEYING LABORATORY INC.510(k) NO: K102480(TRADITIONAL)ATTN: GRACEHOLLANDPHONE NO : 949 262 04119722 AVE. SAUSALITOSE DECISION MADE: 19-APR-11IRVINE CA 92606510(k) SUMMARY AVAILABLE FROM FDADEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVESWEALTH ON (JIANGSU) CO. LTD510(k) NO: K110219(TRADITIONAL)ATTN: CHENGYUSHENPHONE NO : 608 217 93585 CAREY STREETSE DECISION MADE: 19-APR-11PENNINGTON NJ 08534510(k) SUMMARY AVAILABLE FROM FDADEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVESZIBO YUECHUAN PLASTIC PRODUCTS CO.510(k) NO: K110338(TRADITIONAL)ATTN: FRANKLIUPHONE NO : 909 548 482812390 EAST END AVENUESE DECISION MADE: 19-APR-11CHINO CA 91710510(k) SUMMARY AVAILABLE FROM FDADEVICE: SPACELABS SMART DISCLOSURE SYSTEMSPACELABS HEALTHCARE510(k) NO: K110779(SPECIAL)ATTN: THOMASKROENKEPHONE NO : 303 956 4232P.O. BOX 3018SE DECISION MADE: 19-APR-11NEDERLAND CO 80466510(k) SUMMARY AVAILABLE FROM FDADEVICE: EVERON CENTRAL DISPLAY STATION (CDS)EARLYSENSE LTD.510(k) NO: K110521(SPECIAL)ATTN: DALIAARGAMANPHONE NO : 972 375 22330X160TZVI 12SE DECISION MADE: 19-APR-11RAMAT-GANIS 52504510(k) SUMMARY AVAILABLE FROM FDADEVICE: NATUS SLEEPWORKS, MODEL 104017EXCEL-TECH LTD. (XLTEK)510(k) NO: K090277(TRADITIONAL)ATTN: GOLDYSINGHPHONE NO : 905 829 53002568 BRISTOL CIR.SE DECISION MADE: 19-APR-11OAKVILLE, ONTARIOCA L6H 5S1510(k) STATEMENTDEVICE: PARIETEX OPTIMIZED COMPOSTIE MESHSOFRADIM PRODUCTION510(k) NO: K110815(SPECIAL)ATTN: JAMESMCMAHONPHONE NO : 781 839 1787BIOSURGERY 15 CROSBY DRIVESE DECISION MADE: 19-APR-11BEDFORD MA 01730510(k) SUMMARY AVAILABLE FROM FDADEVICE: PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES)SOFRADIM PRODUCTION510(k) NO: K110816(SPECIAL)ATTN: JAMESMCMAHONPHONE NO : 781 839 1787BIOSURGERY 15 CROSBY DRIVESE DECISION MADE: 19-APR-11BEDFORD MA 01730510(k) SUMMARY AVAILABLE FROM FDADEVICE: 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER3M COMPANY-3M HEALTH CARE510(k) NO: K103277(TRADITIONAL)ATTN: SUZANNELEUNGPHONE NO : 651 575 80523M CENTER, BLDG.275-5W-06SE DECISION MADE: 19-APR-11ST. PAUL MN 55133 1006510(k) SUMMARY AVAILABLE FROM FDADEVICE: TRIXEL CO2 LASERBEIJING SYNTECH LASER CO. LTD.510(k) NO: K110434(TRADITIONAL)ATTN: DIANAHONGPHONE NO : 862 122 815850P.O. BOX 237-023SE DECISION MADE: 19-APR-11SHANGHAICH 200237510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEWDEVICE: FLEXIBLE CARDIAC COILLBDS HOLDING COMPANY510(k) NO: K110487(TRADITIONAL)ATTN: RICHARDBRYANTPHONE NO : 214 564 01466440 SKY POINTE DR SUITE 140SE DECISION MADE: 19-APR-11LAS VEGAS NV 89131510(k) STATEMENTDEVICE: BLUE SKY BIO DENTAL IMPLANT SYSTEMBLUE SKY BIO, LLC510(k) NO: K102034(TRADITIONAL)ATTN: ALBERTZICKMANNPHONE NO : 847 548 8499888 E BELVIDERE RD. SUITE 212SE DECISION MADE: 19-APR-11GRAYSLAKE IL 60030510(k) SUMMARY AVAILABLE FROM FDADEVICE: FDI GLUCOSE CONTROL SOLUTION FOR AVIVAFUJIREBIO DIAGNOSTICS, INC510(k) NO: K110436(TRADITIONAL)ATTN: KENTPRUETTPHONE NO : 830 372 1391940 CROSSROADS BLVD.SE DECISION MADE: 20-APR-11SEGUIN TX 78155510(k) SUMMARY AVAILABLE FROM FDADEVICE: COMPUTED DENTAL RADIOGRAPHYSCHICK TECHNOLOGIES, INC.510(k) NO: K110768(SPECIAL)ATTN: SCOTTDOYLEPHONE NO : 718 937 576530-30 47TH AVE.SE DECISION MADE: 20-APR-11LONG ISLAND CITY NY 11101510(k) SUMMARY AVAILABLE FROM FDADEVICE: CELL-TISSUE CONVERTER (CTC) SYRINGE WITH NEEDLERONGSHAN LI510(k) NO: K110112(TRADITIONAL)ATTN: RONGSHANLIPHONE NO : 414 241 102211 GEORGETOWN CT.SE DECISION MADE: 20-APR-11BASKING RIDGE NJ 07920510(k) SUMMARY AVAILABLE FROM FDADEVICE: UCP DRUG SCREENING TEST CUPSUCP BIOSCIENCES, INC.510(k) NO: K110515(SPECIAL)ATTN: NANCYCHENPHONE NO : 408 392 00641445 KOLL CIRCLE, STE. 111SE DECISION MADE: 20-APR-11SAN JOSE CA 95112510(k) SUMMARY AVAILABLE FROM FDADEVICE: CRE BALLOON DILATATION CATHETERBOSTON SCIENTIFIC CORPORATION510(k) NO: K110833(SPECIAL)ATTN: JANISTARANTOPHONE NO : 508 683 4560100 BOSTON SCIENTIFIC WAYSE DECISION MADE: 20-APR-11MARLBOROUGH MA 01752510(k) SUMMARY AVAILABLE FROM FDADEVICE: SPI TITANIUM BASE FOR CAD/CAMTHOMMEN MEDICAL, AG510(k) NO: K102804(TRADITIONAL)ATTN: LINDA K SCHULZPHONE NO : 858 792 123511234 EL CAMINO REAL, SUITE 200SE DECISION MADE: 20-APR-11SAN DIEGO CA 92130510(k) SUMMARY AVAILABLE FROM FDADEVICE: SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2,UNILENS CORP. USA510(k) NO: K110452(SPECIAL)ATTN: ALAN J FRAZERPHONE NO : 727 544 253110431 72ND ST. NORTHSE DECISION MADE: 20-APR-11LARGO FL 33777510(k) STATEMENTDEVICE: SATURN 8000-GSNEW MEDICAL CO. LTD.510(k) NO: K110210(TRADITIONAL)ATTN: JUN-HSIUNGLINPHONE NO : 909 244 65621460 ATTERBURY DR.SE DECISION MADE: 20-APR-11WALNUT CA 91789510(k) SUMMARY AVAILABLE FROM FDADEVICE: SYMBIA.NETSIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K110844(SPECIAL)ATTN: ELAINECHANGPHONE NO : 847 304 75162501 NORTH BARRINGTON RD.SE DECISION MADE: 20-APR-11HOFFMAN ESTATES IL 60192510(k) SUMMARY AVAILABLE FROM FDADEVICE: RESUSCITATION UNIT 105ATOM MEDICAL CORPORATION510(k) NO: K103317(TRADITIONAL)ATTN: PAULDRYDENPHONE NO : 239 498 215524301 WOODSAGE DRIVESE DECISION MADE: 20-APR-11BONITA SPRINGS FL 34134510(k) SUMMARY AVAILABLE FROM FDADEVICE: JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEMPATHWAY MEDICAL TECHNOLOGIES, INC.510(k) NO: K110626(SPECIAL)ATTN: BRIANCLEARYPHONE NO : 425 636 407910801 120TH AVENUE NESE DECISION MADE: 20-APR-11KIRKLAND WA 98033510(k) SUMMARY AVAILABLE FROM FDADEVICE: NEOPIP PATIENT CIRCUIT WITH PEEPNEOFORCE GROUP, INC.510(k) NO: K103833(TRADITIONAL)ATTN: MONICAFERRANTEPHONE NO : 215 672 680035 COMMERCE DR.SE DECISION MADE: 20-APR-11IVYLAND PA 18974510(k) SUMMARY AVAILABLE FROM FDADEVICE: RETCAM 3 OPTHALMIC IMAGING SYSTEMCLARITY MEDICAL SYSTEMS510(k) NO: K102859(TRADITIONAL)ATTN: GARY A SEEGERPHONE NO : 925 463 79845775 WEST LAS POSITAS BLVD. SUITE SE DECISION MADE: 20-APR-11PLEASANTON CA 94588 4084510(k) SUMMARY AVAILABLE FROM FDADEVICE: OSTEOSCAFTEXAS INNOVATIVE Medical DEVICES (510(k) NO: K101827(TRADITIONAL)ATTN: JERRYCHANGPHONE NO : 352 256 27074808 RESEARCH DRIVESE DECISION MADE: 20-APR-11SAN ANTONIO TX 78240510(k) SUMMARY AVAILABLE FROM FDADEVICE: SELECTRA CS LEAD INTRODUCER SYSTEMBIOTRONIK, INC.510(k) NO: K110461(SPECIAL)ATTN: JONBRUMBAUGHPHONE NO : 888 345 03746024 JEAN ROADSE DECISION MADE: 20-APR-11LAKE OSWEGO OR 97035510(k) SUMMARY AVAILABLE FROM FDADEVICE: EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH Chemotherapy DRUGS) W/ A Protein CONTENT LABEL CLAIMMEDLINE INDUSTRIES, INC.510(k) NO: K103602(TRADITIONAL)ATTN: MATTCLAUSENPHONE NO : 847 643 4785ONE MEDLINE PLACESE DECISION MADE: 21-APR-11MUNDELEIN IL 60060 4486510(k) SUMMARY AVAILABLE FROM FDADEVICE: 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEMSYNTHES USA510(k) NO: K110125(TRADITIONAL)ATTN: CHRISTOPHERHACK, ESQ.PHONE NO : 610 719 69401301 GOSHEN PKWYSE DECISION MADE: 21-APR-11WEST CHESTER PA 19380510(k) SUMMARY AVAILABLE FROM FDADEVICE: TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15)ORTHOGEM LIMITED510(k) NO: K110787(SPECIAL)ATTN: WE-JENLOPHONE NO : 441 159 505721BIOCITY, PENNYFOOT STREETSE DECISION MADE: 21-APR-11NOTTINGHAMUK NG1 1GF510(k) SUMMARY AVAILABLE FROM FDADEVICE: HELENA SYSTEMROYAL OAK MEDICAL DEVICES510(k) NO: K110177(TRADITIONAL)ATTN: MATTHEWKROLLPHONE NO : 248 628 283039533 WOODWARD AVENUESE DECISION MADE: 21-APR-11BLOOMFIELD HILLS MI 48304510(k) SUMMARY AVAILABLE FROM FDADEVICE: IFUSE IMPLANT SYSTEMSI-BONE, INC.510(k) NO: K110838(SPECIAL)ATTN: JANICE M HOGANPHONE NO : 267 675 46111835 MARKET STREET 29TH FLOORSE DECISION MADE: 21-APR-11PHILADELPHIA PA 19103510(k) SUMMARY AVAILABLE FROM FDADEVICE: INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOMINTRA-LOCK INTERNATIONAL, INC.510(k) NO: K103194(ABBREVIATED)ATTN: ANGELABLACKWELLPHONE NO : 704 450 99346560 WEST ROGERS CIRCLESE DECISION MADE: 21-APR-11BOCA RATON FL 33487510(k) SUMMARY AVAILABLE FROM FDADEVICE: BODYFLOW P2CHPHYSIOMED ELEKTROMEDIZIN AG510(k) NO: K100862(TRADITIONAL)ATTN: BIRGITSCHMIDPHONE NO : 499 126 258717HUTWEIDE 10SE DECISION MADE: 21-APR-11SCHNAITTACH/LAIPERSDORFGM D-91510(k) SUMMARY AVAILABLE FROM FDADEVICE: CURVE IMAGECURVE DENTAL, INC.510(k) NO: K110139(TRADITIONAL)ATTN: CAROLINETONTINIPHONE NO : 512 327 9997611 WEST 5TH STREET, THIRD FLOORSE DECISION MADE: 21-APR-11AUSTIN TX 78701510(k) SUMMARY AVAILABLE FROM FDADEVICE: XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0CEPHEID510(k) NO: K103766(TRADITIONAL)ATTN: KERRY J FLOMPHONE NO : 408 400 8460904 CARIBBEAN DRIVESE DECISION MADE: 21-APR-11SUNNYVALE CA 94089 1189510(k) SUMMARY AVAILABLE FROM FDADEVICE: JETPACK 2.0PHILIPS MEDICAL SYSTEMS (CLEVELAND510(k) NO: K111024(TRADITIONAL)ATTN: LORI R PETERSONPHONE NO : 408 468 30423860 NORTH 1ST STREETSE DECISION MADE: 21-APR-11SAN JOSE CA 95134510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEWDEVICE: EASYRA UREA NITROGEN AND CREATININE REAGENTSMEDICA CORP.510(k) NO: K110675(TRADITIONAL)ATTN: PHOTIOSMAKRISPHONE NO : 781 541 74435 OAK PARK DRIVESE DECISION MADE: 21-APR-11BEDFORD MA 01730510(k) SUMMARY AVAILABLE FROM FDADEVICE: PRECISION LIQUID OXYGEN SYSTEMPRECISION MEDICAL, INC.510(k) NO: K103324(TRADITIONAL)ATTN: JAMESPARKERPHONE NO : 610 262 6090300 HELD DRIVESE DECISION MADE: 21-APR-11NORTHAMPTON PA 18067510(k) SUMMARY AVAILABLE FROM FDADEVICE: SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABELSYNTEX HEALTHCARE PRODUCTS CO. LT510(k) NO: K103770(TRADITIONAL)ATTN: KATHYLIUPHONE NO : 909 590 16113973 SCHAEFER AVESE DECISION MADE: 21-APR-11CHINO CA 91710510(k) SUMMARY AVAILABLE FROM FDADEVICE: GSP NEONATAL THYROXINE (T4)WALLAC OY, A SUBSIDIARY OF PERKINE510(k) NO: K103484(TRADITIONAL)ATTN: SUSAN K HAMANNPHONE NO : 781 663 5872940 WINTER STREETSE DECISION MADE: 22-APR-11WALTHAM MA 02451510(k) SUMMARY AVAILABLE FROM FDADEVICE: C.T.M. MOBILITY SCOOTER HS515(3W)C.T.M. HOMECARE PRODUCT, INC.510(k) NO: K110567(TRADITIONAL)ATTN: SHEILARAMERMANPHONE NO : 541 683 3017927 THRONE DRIVESE DECISION MADE: 22-APR-11EUGENE OR 97402510(k) SUMMARY AVAILABLE FROM FDADEVICE: VENX REVOLUTIONVENX LLC510(k) NO: K110355(TRADITIONAL)ATTN: IRADUESLERPHONE NO : 315 868 56454700 S. OVERLAND DRIVESE DECISION MADE: 22-APR-11TUCSON' AZ 85714510(k) SUMMARY AVAILABLE FROM FDADEVICE: C.T.M. MOBILITY SCOOTER - MODEL HS 118C.T.M. HOMECARE PRODUCT, INC.510(k) NO: K110395(TRADITIONAL)ATTN: SHEILARAMERMANPHONE NO : 541 683 3017927 THRONE DRIVESE DECISION MADE: 22-APR-11EUGENE OR 97402510(k) SUMMARY AVAILABLE FROM FDADEVICE: REVISION PROTHESISSMITH & NEPHEW, INC.510(k) NO: K110837(SPECIAL)ATTN: MEGANBEVILLPHONE NO : 901 399 53401450 EAST BROOKS RD.SE DECISION MADE: 22-APR-11MEMPHIS TN 38116510(k) SUMMARY AVAILABLE FROM FDADEVICE: WINCO STRETCHAIRWINCO MFG. LLC510(k) NO: K110671(TRADITIONAL)ATTN: JIMANKOVIAKPHONE NO : 352 854 29295516 SW 1st LnSE DECISION MADE: 22-APR-11Ocala FL 34474510(k) SUMMARY AVAILABLE FROM FDADEVICE: RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLORRUBBERCARE PROTECTION PRODUCTS (M)510(k) NO: K102902(TRADITIONAL)ATTN: LIMKWEE SHYANPHONE NO : 606 677 2781OFF JALAN SENAWANG EMPAT SENAWANG SE DECISION MADE: 22-APR-11SEREMBAN, NEGERI SEMBILANMY 70510(k) SUMMARY AVAILABLE FROM FDADEVICE: POSEY BEDJ. T. POSEY CO.510(k) NO: K103817(TRADITIONAL)ATTN: ROBERTKELLEHERPHONE NO : 626 454 21095635 PECK RD.SE DECISION MADE: 22-APR-11ARCADIA CA 91006510(k) SUMMARY AVAILABLE FROM FDADEVICE: AVS ANCHOR-C CERVICAL CAGE SYSTEMSTRYKER SPINE510(k) NO: K102606(TRADITIONAL)ATTN: KIMBERLYLANEPHONE NO : 201 760 82152 PEARL COURTSE DECISION MADE: 22-APR-11ALLENDALE NJ 07401 1677510(k) SUMMARY AVAILABLE FROM FDADEVICE: INVADER MTHFR 1298HOLOGIC, INC.510(k) NO: K100496(TRADITIONAL)ATTN: RANDALL J COVILLPHONE NO : 508 263 8853250 CAMPUS DRIVESE DECISION MADE: 25-APR-11MARLBOROUGH MA 01752510(k) SUMMARY AVAILABLE FROM FDADEVICE: PROTECTIVE RESTRAINTMEDI-TECH INTL. CORP.510(k) NO: K110377(TRADITIONAL)ATTN: MARILYNGEIGERPHONE NO : 414 570 888026 COURT ST. SUITE 1301SE DECISION MADE: 25-APR-11BROOKLYN NY 11242510(k) SUMMARY AVAILABLE FROM FDADEVICE: SOLCART BB. BRAUN AVITUM AG510(k) NO: K102194(TRADITIONAL)ATTN: ANGELACARAVELLAPHONE NO : 610 266 0500901 MARCON BLVD.SE DECISION MADE: 25-APR-11ALLENTOWN PA 18109510(k) SUMMARY AVAILABLE FROM FDADEVICE: VAPRO PLUS INTERMITTENT CATHETERHOLLISTER, INCORPORATED510(k) NO: K110862(SPECIAL)ATTN: CHRISSTUKELPHONE NO : 847 918 34522000 HOLLISTER DRIVESE DECISION MADE: 26-APR-11;IBERTYVILLE IL 60048510(k) SUMMARY AVAILABLE FROM FDADEVICE: NOVAKONE SPHERICAL AND TORIC LENSESALDEN OPTICAL LABS. INC.510(k) NO: K102557(TRADITIONAL)ATTN: CHARLES H CREIGHTONPHONE NO : 716 937 918113295 BROADWAYSE DECISION MADE: 26-APR-11ALDEN NY 14004510(k) STATEMENTDEVICE: AW VOLUMESHARE 5 WITH ANGIOVIZ OPTIONGE HEALTHCARE510(k) NO: K110834(SPECIAL)ATTN: HELENPENGPHONE NO : 262 548 50913000 NORTH.GRANDVIEW BLVD. W1140SE DECISION MADE: 26-APR-11WAUKESHA WI 53188510(k) SUMMARY AVAILABLE FROM FDADEVICE: ZEUS ELISA HSV GC-I IGG TEST SYSTEMZEUS SCIENTIFIC, INC.510(k) NO: K103363(TRADITIONAL)ATTN: EWANADOLCZAKPHONE NO : 908 526 3744200 EVANS WAYSE DECISION MADE: 26-APR-11BRANCHBURG NJ 08876510(k) STATEMENTDEVICE: DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEMEDAN INSTRUMENTS, INC.510(k) NO: K110999(TRADITIONAL)ATTN: RANDYJIANGPHONE NO : 867 552 68587364/F, NEW ENERGY BLDG. 2009 NANYOUSE DECISION MADE: 26-APR-11NANSHAN, GUANGDONGCH 518054510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEWDEVICE: DISPOSABLE INSULIN SYRINGEWENZHOU WUZHOU IMPORT & EXPORT CO.510(k) NO: K110421(TRADITIONAL)ATTN: DIANAHONGPHONE NO : 862 164 264467P.O. BOX 237-023SE DECISION MADE: 26-APR-11BINGYI XIANG, ZHEJIANGCH 32500510(k) SUMMARY AVAILABLE FROM FDADEVICE: PRESTODR 4143CMT MEDICAL TECHNOLOGIES, LTD.510(k) NO: K110849(SPECIAL)ATTN: SHLOMIDINESPHONE NO : 972 485 66220INDUSTRIAL PARK P.O.B. 111SE DECISION MADE: 26-APR-11YOQNEAM ILITIS 20692510(k) SUMMARY AVAILABLE FROM FDADEVICE: IMPELLA CONTROLLER WITH FLOW CONTROLABIOMED, INC.510(k) NO: K110845(SPECIAL)ATTN: ROBERTSTEWARTPHONE NO : 978 646 156722 CHERRY HILL DR.SE DECISION MADE: 27-APR-11DANVERS MA 01923510(k) SUMMARY AVAILABLE FROM FDADEVICE: UNIVERSAL DIGITAL INTERFACE (UDI) 1717MERIDIAN MEDICAL SYSTEMS, LLC510(k) NO: K103599(TRADITIONAL)ATTN: ARIELMARCIANOPHONE NO : 407 719 9853325 HARRIS DRIVESE DECISION MADE: 27-APR-11AURORA OH 44202510(k) STATEMENTDEVICE: AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEMTORNIER, INC.510(k) NO: K110865(SPECIAL)ATTN: BRAHIMHADRIPHONE NO : 978 232 9997100 CUMMINGS CENTER, SUITE 444CSE DECISION MADE: 27-APR-11BEVERLY MA 01915510(k) SUMMARY AVAILABLE FROM FDADEVICE: TRIPLEX ER. YAG / ND: YAG SYSTEMSANDSTONE MEDICAL TECHNOLOGIES, LL510(k) NO: K110502(TRADITIONAL)ATTN: MARKROHRERPHONE NO : 205 290 8251105 CITATION COURTSE DECISION MADE: 27-APR-11HOMEWOOD AL 35209510(k) SUMMARY AVAILABLE FROM FDADEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVESHEBEI TENGDA PLASTIC CO. LTD510(k) NO: K102151(TRADITIONAL)ATTN: CHUXIAOANPHONE NO : 861 082 387441ROOM 1606 BLDG.1 JIANXIANG YUA NO.SE DECISION MADE: 27-APR-11SHIJIAZHUANGCH 100083510(k) SUMMARY AVAILABLE FROM FDADEVICE: FILMARRAY RP PANELIDAHO TECHNOLOGY, INC.510(k) NO: K110764(TRADITIONAL)ATTN: BETHLINGENFELTERPHONE NO : 801 736 6354390 WAKARA WAYSE DECISION MADE: 27-APR-11SALT LAKE City UT 84108510(k) SUMMARY AVAILABLE FROM FDADEVICE: SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILYSOLARC SYSTEMS INC.510(k) NO: K103204(TRADITIONAL)ATTN: BRUCEELLIOTTPHONE NO : 705 739 30481515 SNOW VALLEY ROADSE DECISION MADE: 27-APR-11MINESING,ONTARIOCA L0L 1Y3510(k) SUMMARY AVAILABLE FROM FDADEVICE: CUBESCAN / BIOCON-700MCUBE TECHNOLOGY CO. LTD.510(k) NO: K111021(TRADITIONAL)ATTN: SEUNGTAIKIMPHONE NO : 822 342 17780803 SHINNAE-TECHNOTOWN 485 SANGBONSE DECISION MADE: 27-APR-11CHUNGNANG-KU, SEOULKS 131-220 510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEWDEVICE: UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM Software VERSION 5.0BECKMAN COULTER, INC.510(k) NO: K103842(TRADITIONAL)ATTN: MARINEBOYAJIANPHONE NO : 714 961 6536250 S. KRAEMER BOULEVARD MAIL STOPSE DECISION MADE: 27-APR-11BREA CA 92821510(k) SUMMARY AVAILABLE FROM FDADEVICE: LIGHTY DD INFUSION SETMEDX-SET LTD510(k) NO: K110282(TRADITIONAL)ATTN: RAYMONDKELLYPHONE NO : 603 595 009556B SHAWDOW DR.SE DECISION MADE: 27-APR-11HUDSON NH 03051510(k) STATEMENTDEVICE: TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTSTHUNDER TIGER CORP.510(k) NO: K102517(TRADITIONAL)ATTN: JOLEEPHONE NO : 886 423 591616NO. 7, 6TH ROAD INDUSTRY PARKSE DECISION MADE: 27-APR-11TAICHUNGTW 40755510(k) SUMMARY AVAILABLE FROM FDADEVICE: DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SETDIAZYME LABORATORIES510(k) NO: K103557(TRADITIONAL)ATTN: ABHIJITDATTAPHONE NO : 858 455 476212889 GREGG COURTSE DECISION MADE: 27-APR-11POWAY CA 92064510(k) SUMMARY AVAILABLE FROM FDADEVICE: PCL TIGHTROPEARTHREX, INC.510(k) NO: K110123(TRADITIONAL)ATTN: COURTNEYSMITHPHONE NO : 239 643 55531370 CREEKSIDE BLVD.SE DECISION MADE: 28-APR-11NAPLES FL 34108 1945510(k) SUMMARY AVAILABLE FROM FDADEVICE: AUTOSURE VOICE 3 BLOOD Glucose Monitoring Organisation AND TEST STRIPAPEX BIOTECHNOLOGY CORP.510(k) NO: K102481(SPECIAL)ATTN: LISALIUPHONE NO : 866 356 41952NO. 7, LI-HSIN ROAD V, HSINCHU SCISE DECISION MADE: 28-APR-11HSINCHUTW 30078510(k) SUMMARY AVAILABLE FROM FDADEVICE: FEMVUE SALINE-AIR DEVICEFEMASYS INC.510(k) NO: K110288(TRADITIONAL)ATTN: LISAPEACOCKPHONE NO : 770 500 39105000 RESEARCH COURT STE .100SE DECISION MADE: 28-APR-11SUWANEE GA 30024510(k) SUMMARY AVAILABLE FROM FDADEVICE: MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10MICROVENTION, INC.510(k) NO: K103758(SPECIAL)ATTN: LARAINEPANGELINAPHONE NO : 714 247 81501311 VALENCIA AVESE DECISION MADE: 28-APR-11TUSTIN CA 92780510(k) SUMMARY AVAILABLE FROM FDADEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVESHEBEI TENGDA PLASTIC CO. LTD510(k) NO: K102152(TRADITIONAL)ATTN: CHUXIAOANPHONE NO : 861 082 387441ROOM 1606 BLDG.1 JIANXIANG YUA NO.SE DECISION MADE: 28-APR-11SHIJIAZHUANGCH 100083510(k) SUMMARY AVAILABLE FROM FDADEVICE: BD PEN NEEDLEBECTON DICKINSON AND COMPANY (BD) 510(k) NO: K110105(SPECIAL)ATTN: PASQUALEAMATOPHONE NO : 201 847 45131 BECTON DRIVE. MC372SE DECISION MADE: 28-APR-11FRANKLIN LAKES NJ 07417 1885510(k) SUMMARY AVAILABLE FROM FDADEVICE: ONE DAY FLAT PACKMENICON CO. LTD.510(k) NO: K102895(TRADITIONAL)ATTN: MARTINDALSINGPHONE NO : 970 243 5490806 KIMBALL AVENUESE DECISION MADE: 28-APR-11GRAND JUNCTION CO 81501510(k) SUMMARY AVAILABLE FROM FDADEVICE: BIOMARC FIDUCIAL MARKERCARBON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K110772(TRADITIONAL)ATTN: ANDREW J ADAMSPHONE NO : 651 653 85121290 HAMMOND RD.SE DECISION MADE: 28-APR-11ST. PAUL MN 55110 5867510(k) SUMMARY AVAILABLE FROM FDADEVICE: RENAISSANCE SYSTEMMAZOR ROBOTICS LTD510(k) NO: K110911(SPECIAL)ATTN: AHAVASTEINPHONE NO : 972 976 7000220 HATA'AS ST.SE DECISION MADE: 28-APR-11KFAR SABAIS 44425510(k) SUMMARY AVAILABLE FROM FDADEVICE: SPECTRA LASER SYSTEMLUTRONIC CORPORATION510(k) NO: K103455(SPECIAL)ATTN: JHUNGWON VOJIRPHONE NO : 609 275 156551 EVERETT DRIVE, UNIT A-50SE DECISION MADE: 28-APR-11PRINCETON JUNCTION NJ 08550510(k) SUMMARY AVAILABLE FROM FDADEVICE: IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)SIEMENS HEALTHCARE DIAGNOSTICS510(k) NO: K103683(ABBREVIATED)ATTN: GAROMIMARYANPHONE NO : 914 524 3270511 BENEDICT AVENUESE DECISION MADE: 28-APR-11TARRYTOWN NY 10591510(k) SUMMARY AVAILABLE FROM FDADEVICE: R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROLR & D SYSTEMS, INC.510(k) NO: K101578(TRADITIONAL)ATTN: NANCYRINGPHONE NO : 612 656 4533614 MCKINLEY PL. N.E.SE DECISION MADE: 28-APR-11MINNEAPOLIS MN 55413510(k) SUMMARY AVAILABLE FROM FDADEVICE: CUTTING EDGE SPINE INTERBODY FUSION DEVICECUTTING EDGE SPINE, LLC510(k) NO: K102957(TRADITIONAL)ATTN: JOHNKAPITANPHONE NO : 704 843 7852100 E. SOUTH Main STREET PO BOX 14SE DECISION MADE: 28-APR-11MATTHEWS NC 28173510(k) SUMMARY AVAILABLE FROM FDADEVICE: AGACHAMBER SPACERAGAPLASTIC IND. COM. LTDA.510(k) NO: K101348(TRADITIONAL)ATTN: MARIA F GRIFFINPHONE NO : 704 843 167555 NORTHERN BLVD SUITE 200SE DECISION MADE: 29-APR-11GREAT NECK NY 11021510(k) SUMMARY AVAILABLE FROM FDADEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVESCHANGDA PLASTIC PRODUCT CO. LTD510(k) NO: K103196(TRADITIONAL)ATTN: WANGLINPHONE NO : 86 310 3096390WANGZHUANG TOWN, LI COUNTYSE DECISION MADE: 29-APR-11HANDAN CITYCH 056001510(k) SUMMARY AVAILABLE FROM FDADEVICE: FORTROSS BONE VOID FILLERPIONEER SURGICAL TECHNOLOGY510(k) NO: K110561(SPECIAL)ATTN: DAVID J COLLETTEPHONE NO : 858 792 123511234 EL CAMINO REAL SUITE 200SE DECISION MADE: 29-APR-11SAN DIEGO CA 92130510(k) SUMMARY AVAILABLE FROM FDADEVICE: REUSABLE TEST PACK FOR DANA EMULATING INDICATORSDANA PRODUCTS, INC.510(k) NO: K110253(TRADITIONAL)ATTN: HARRYBALAPHONE NO : 847 455 28817 COREY DR.SE DECISION MADE: 29-APR-11SOUTH BARRINGTON IL 60010510(k) STATEMENTDEVICE: KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKSKIMBERLY-CLARK CORP.510(k) NO: K110455(ABBREVIATED)ATTN: ANNWATERHOUSEPHONE NO : 678 352 67191400 HOLCOMB BRIDGE RD.SE DECISION MADE: 29-APR-11ROSWELL GA 30076510(k) SUMMARY AVAILABLE FROM FDATHIRD PARTY REVIEWTOTAL 510(k)s THIS PERIOD240TOTAL WITH SUMMARIES226TOTAL WITH STATEMENTS14
- Login or show to place comments
- Printer-friendly version
No comments:
Post a Comment