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U.S. Department of Health and Human Services

Medical Devices

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May 2014 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD May 2014
 
 
DEVICE: I-CHROMA IFOB WITH I-CHROMA READER
BODITECH MED INC.                 510(k) NO: K132167(TRADITIONAL)
ATTN: SANG  YEOL PARK             PHONE NO : 82 33 2431400
43, GEODUDANJI 1-GIL, DONGNAE-MYEOSE DECISION MADE: 02-MAY-14
CHUNCHEON-SI, GANG-WON-DO    KS 20510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FILMARRAY GASTROINTESTINAL (GI) PANEL
BIOFIRE DIAGNOSTICS               510(k) NO: K140407(TRADITIONAL)
ATTN: BETH  LINGENFELTER          PHONE NO : 801 736 6354   
390 WAKARA WAY                    SE DECISION MADE: 02-MAY-14
SALT LAKE CITY UT 84108           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENT
BECTON, DICKINSON AND COMPANY     510(k) NO: K140111(TRADITIONAL)
ATTN: PAUL  SWIFT                 PHONE NO : 410 316 4905   
7 LOVETON CIRCLE                  SE DECISION MADE: 06-MAY-14
SPARKS MD 21152                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT
CAROLINA LIQUID CHEMISTRIES CORP. 510(k) NO: K132711(TRADITIONAL)
ATTN: PHILIP G SHUGART            PHONE NO : 877 722 8910   
575 N. PATTERSON AVE. SUITE 430   SE DECISION MADE: 08-MAY-14
WINSTON-SALEM NC 27101            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DUET SYSTEM
BIOVIEW LTD.                      510(k) NO: K130775(TRADITIONAL)
ATTN: ORLY  MAOR                  PHONE NO : 972 9 7453607
25A SIRKIN ST.                    SE DECISION MADE: 09-MAY-14
KFAR SABA    IS 44421             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG
ABBOTT MOLECULAR, INC.            510(k) NO: K140354(TRADITIONAL)
ATTN: STACY  FERGUSON             PHONE NO : 224 361 7449   
1300 EAST TOUHY AVENUE            SE DECISION MADE: 09-MAY-14
DES PLAINES IL 60018              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL
MEDICA CORPORATION                510(k) NO: K130080(TRADITIONAL)
ATTN: PHOTIOS  MAKRIS             PHONE NO : 781 275 4892   
5 OAK PARK DRIVE                  SE DECISION MADE: 13-MAY-14
BEDFORD MA 01730                  510(k) STATEMENT
 
DEVICE: IMDX HSV-1/2 FOR ABBOTT M2000
INTELLIGENT MEDICAL DEVICES, INC. 510(k) NO: K140198(TRADITIONAL)
ATTN: FRAN  WHITE                 PHONE NO : 978 927 3808   
180 CABOT ST                      SE DECISION MADE: 13-MAY-14
BEVERLY MA 01915                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: QUICKSCREEN AMPHETINE 500 TEST
PHAMATECH INC.                    510(k) NO: K131069(TRADITIONAL)
ATTN: CARL A MONGIOVI             PHONE NO : 858 643 5555   
10151 BARNES CANYON RD            SE DECISION MADE: 14-MAY-14
San Diego CA 92121                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK
JAS DIAGNOSTICS, INC.             510(k) NO: K130915(TRADITIONAL)
ATTN: DAVID H JOHNSTON            PHONE NO : 305 418 2320   
14100 N.W. 57th Court             SE DECISION MADE: 15-MAY-14
Miami Lakes FL 33014              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CAROLINA LIQUID CHEMISTRIES CLC 6410  CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR
CAROLINA LIQUID CHEMISTRIES CORP. 510(k) NO: K133519(TRADITIONAL)
ATTN: MELISSA F THOMPSON          PHONE NO : 877 722 8910   
575 N. PATTERSON AVE. SUITE 430   SE DECISION MADE: 16-MAY-14
WINSTON-SALEM NC 27101            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
LEICA BIOSYSTEMS NEWCASTLE LTD    510(k) NO: K122556(TRADITIONAL)
ATTN: BARBARA-ANN  CONWAY-MAYERS  PHONE NO : 312 259 7205   
5205 ROUTE 12                     SE DECISION MADE: 19-MAY-14
RICHMOND IL 60071                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
BECTON, DICKINSON & CO.           510(k) NO: K140446(TRADITIONAL)
ATTN: SHERMA  WINSTON             PHONE NO : 410 316 4145   
7 LOVETON CIR.                    SE DECISION MADE: 20-MAY-14
SPARKS MD 21152 0999              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
BECTON, DICKINSON & CO.           510(k) NO: K140448(TRADITIONAL)
ATTN: SHERMA  WINSTON             PHONE NO : 410 316 4145   
7 LOVETON CIR.                    SE DECISION MADE: 20-MAY-14
SPARKS MD 21152 0999              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM
ANDON HEALTH CO., LTD             510(k) NO: K133790(SPECIAL)
ATTN: YI  LIU                     PHONE NO : 86 22 60526161
No. 3 Jin Ping Street,Ya An Road, SE DECISION MADE: 22-MAY-14
TIANJIN    CN 300190              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CAPTIA MEASLES IGM
TRINITY BIOTECH USA               510(k) NO: K140455(TRADITIONAL)
ATTN: BONNIE B DEJOY              PHONE NO : 716 483 3851   
2823 Girts Rd                     SE DECISION MADE: 22-MAY-14
JAMESTOWN NY 14701                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ANTHRACIS REAL-TIME PCR ASSAY
CENTERS FOR DISEASE CONTROL AND PR510(k) NO: K140426(TRADITIONAL)
ATTN: HYE-JOO  KIM                PHONE NO : 404 639 4643   
1600 CLIFTON RD. NE, MS-C18       SE DECISION MADE: 22-MAY-14
ATLANTA GA 30333                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K132801(TRADITIONAL)
ATTN: ERNEST  JOSEPH              PHONE NO : 914 524 2431   
511 BENEDICT AVE.                 SE DECISION MADE: 28-MAY-14
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: URS-2GP (GLUCOSE PROTEIN) URINE STRIPS
TECO DIAGNOSTICS                  510(k) NO: K131600(TRADITIONAL)
ATTN: STEVE  PARTONO              PHONE NO : 714 463 1111   
1268 NORTH LAKEVIEW AVE.          SE DECISION MADE: 29-MAY-14
ANAHEIM CA 92807                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SILVERLON ISLAND WOUND DRESSING
ARGENTUM MEDICAL, LLC.            510(k) NO: K122817(TRADITIONAL)
ATTN: WALT  BRITTLE               PHONE NO : 410 220 2800   
810 LANDMARK DRIVE SUITE 126      SE DECISION MADE: 01-MAY-14
GLEN BURNIE MD 21061              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
ZIBO INTCO MEDICAL PRODUCTS CO., L510(k) NO: K132637(TRADITIONAL)
ATTN: FRANK  LIU                  PHONE NO : 909 548 4828   
12390 EAST END AVE.               SE DECISION MADE: 01-MAY-14
CHINO CA 91710                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: STABILIZATION SCREW
IN2BONES SAS                      510(k) NO: K131920(TRADITIONAL)
ATTN: NORMAN F ESTRIN, PH.D.      PHONE NO : 301 279 2899   
9109 COPENHAVER DR.               SE DECISION MADE: 01-MAY-14
POTOMAC MD 20854                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OEC 9800 PLUS
GE OEC MEDICAL SYSTEMS, INC       510(k) NO: K132027(SPECIAL)
ATTN: JEFF  WAGNER                PHONE NO : 801 517 6415   
384 WRIGHT BROTHERS DR.           SE DECISION MADE: 01-MAY-14
Salt Lake Cty UT 84116            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: COLLACARE DENTAL
INNOCOLL PHARMACEUTICALS          510(k) NO: K133290(TRADITIONAL)
ATTN: AARON  WYSE                 PHONE NO : 353 090 6666091
DUBLIN ROAD                       SE DECISION MADE: 01-MAY-14
ATHLONE, CO. WESTMEATH    EI      510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SUSTAIN
HOLLENDER SUSTAINABLE BRANDS LLC  510(k) NO: K131866(ABBREVIATED)
ATTN: E.J.  SMITH                 PHONE NO : 888 729 9674   
1468 HARWELL AVE                  SE DECISION MADE: 01-MAY-14
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RESPIRATORY GAS HUMIDIFIER
PACIFIC MEDICO CO., LTD.          510(k) NO: K132857(SPECIAL)
ATTN: YOSHIO  TOYAMA              PHONE NO : 813 3818 86127
2-6-4 HONGO                       SE DECISION MADE: 01-MAY-14
BUNKYO-KU, TOKYO    JA 113-0033   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN C
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K140818(ABBREVIATED)
ATTN: ERNEST  JOSEPH              PHONE NO : 914 524 2431   
511 BENEDICT AVE.                 SE DECISION MADE: 01-MAY-14
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: XCAGE INTERBODY FUSION SYSTEM
OUROBOROS MEDICAL                 510(k) NO: K133514(TRADITIONAL)
ATTN: JOHN  TO                    PHONE NO : 510 933 3441   
47757 FREMONT BLVD                SE DECISION MADE: 01-MAY-14
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ORTHOPEDIC FIXATION SYSTEMS
IMPACT MEDICAL, LLC               510(k) NO: K140216(TRADITIONAL)
ATTN: EJ  DUFFY                   PHONE NO : 503 521 7669   
10110 SW NIMBUS AVE. STE B6       SE DECISION MADE: 01-MAY-14
PORTLAND OR 97223                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY
STRYKER SUSTAINABILITY SOLUTIONS  510(k) NO: K133672(TRADITIONAL)
ATTN: SCOTT  ENGLISH              PHONE NO : 888 888 3433   
1810 WEST DRAKE DRIVE             SE DECISION MADE: 01-MAY-14
TEMPE AZ 85283                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE
AVINGER, INC.                     510(k) NO: K140185(TRADITIONAL)
ATTN: SHERRY  KIM                 PHONE NO : 650 241 7004   
400 CHESAPEAKE DRIVE              SE DECISION MADE: 01-MAY-14
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM
SEASPINE, INC.                    510(k) NO: K133418(TRADITIONAL)
ATTN: JEFF  BRITTAN               PHONE NO : 760 727 8399   
2302 LA MIRADA DR.                SE DECISION MADE: 01-MAY-14
VISTA CA 92081 7862               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE
CREO QUALITY, LLC.                510(k) NO: K132004(TRADITIONAL)
ATTN: JON  SPEER                  PHONE NO : 765 315 2736   
P.O. BOX 1784                     SE DECISION MADE: 02-MAY-14
MARTINSVILLE IN 46151             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SHARPS CONTAINER
GRP & ASSOCIATES                  510(k) NO: K132476(TRADITIONAL)
ATTN: ROBERT  SEIPLE              PHONE NO : 512 327 9997   
816 CONGRESS, SUITE 1400          SE DECISION MADE: 02-MAY-14
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PULMONE MINIBOX PFT TM
PULMONE ADVANCED MEDICAL DEVICES, 510(k) NO: K133051(TRADITIONAL)
ATTN: RHONA  SHANKER              PHONE NO : 301 251 9570   
12154 DARNESTOWN RD, #236         SE DECISION MADE: 02-MAY-14
GAITHERSBURG MD 20878   20878     510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ACCUTORR 7 VITAL SIGNS MONITOR
MINDRAY NORTH AMERICA             510(k) NO: K132038(ABBREVIATED)
ATTN: RUSSELL  OLSEN              PHONE NO : 201 995 8391   
800 MACARTHUR BLVD                SE DECISION MADE: 02-MAY-14
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MANUKA FOAM HC, MANUKA FOAM HC (WITH ACRYLIC ADHESIVE BORDER), MANUKA FOAM HC (WITH SILICONE ADHESIVE BORDER)
LINKS MEDICAL PRODUCTS, INC.      510(k) NO: K133934(TRADITIONAL)
ATTN: JAMES  SMITH                PHONE NO : 949 340 7261   
29442 POINTE ROYALE               SE DECISION MADE: 02-MAY-14
LAGUNA HILLS CA 92677             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NUVASIVE EMG ENDOTRACHEAL TUBE
NUVASIVE, INCORPORATED            510(k) NO: K133530(TRADITIONAL)
ATTN: JEREMY  MARKOVICH           PHONE NO : 858 309 3783   
7475 LUSK BLVD                    SE DECISION MADE: 02-MAY-14
SAN DIEGO CA 92121   92121        510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31
ENVITEC-WISMAR GMBH               510(k) NO: K133064(TRADITIONAL)
ATTN: STEPHEN  GORSKI             PHONE NO : 262 594 2114   
S65 W35739 PIPER ROAD             SE DECISION MADE: 02-MAY-14
EAGLE WI 53119                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MATRIXRIB FIXATION SYSTEM
SYNTHES (USA) PRODUCTS LLC        510(k) NO: K133616(TRADITIONAL)
ATTN: DAMON  LEES                 PHONE NO : 610 719 5608   
1301 GOSHEN PKWY                  SE DECISION MADE: 02-MAY-14
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SWIFT-LOCK ANCHOR
ST. JUDE MEDICAL                  510(k) NO: K140272(TRADITIONAL)
ATTN: DIANA  ORTEGA               PHONE NO : 972 309 8000   
6901 PRESTON ROAD                 SE DECISION MADE: 02-MAY-14
PLANO TX 75024                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PROPELLER SYSTEM - MODEL 2
RECIPROCAL LABS CORPORATION       510(k) NO: K140638(TRADITIONAL)
ATTN: J. DAVID  SICKLE            PHONE NO : 
634 W Main St Ste 102             SE DECISION MADE: 02-MAY-14
Madison WI 53703                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: GIGALASER
POWERMEDIC APS                    510(k) NO: K134017(TRADITIONAL)
ATTN: M. JOYCE  HEINRICH          PHONE NO : 713 734 4433   
12101 CULLEN BLVD SUITE A         SE DECISION MADE: 02-MAY-14
HOUSTON TX 77047 2951             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS
C.R. BARD, INC.                   510(k) NO: K140856(SPECIAL)
ATTN: MICHELE  DAVIS              PHONE NO : 770 784 6274   
8195 INDUSTRIAL BLVD.             SE DECISION MADE: 02-MAY-14
COVINGTON GA 30014                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INFILL CERVICAL
PINNACLE SPINE GROUP, LLC         510(k) NO: K140066(TRADITIONAL)
ATTN: REBECCA K PINE              PHONE NO : 760 809 5178   
1601 ELM ST STE 1930              SE DECISION MADE: 05-MAY-14
Dallas TX 75201                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AIRVIEW MINI OWIE DICK TEST PACK
CROSSTEX INTERNATIONAL            510(k) NO: K133204(TRADITIONAL)
ATTN: MICHAEL G NOLAN             PHONE NO : 585 359 0130   
6789 WEST HENRIETTA ROAD          SE DECISION MADE: 05-MAY-14
RUSH NY 14543                     510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: COBAS CT/NG V2.0 TEST
ROCHE MOLECULAR SYSTEMS, INC.     510(k) NO: K140887(SPECIAL)
ATTN: WILK VON  GUSTEDT           PHONE NO : 925 730 8046   
4300 HACIENDA DRIVE               SE DECISION MADE: 05-MAY-14
PLEASANTON CA 94588 2722          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEM
HALO MEDICAL TECHNOLOGIES, LLC    510(k) NO: K140899(TRADITIONAL)
ATTN: JENNIFER L KINNEY           PHONE NO : 505 231 6452   
1805 FOULK ROAD, SUITE G          SE DECISION MADE: 05-MAY-14
WILMINGTON DE 19810               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: DENRACLE DENTAL ABUTMENT
GREEN DENTECH CO LTD              510(k) NO: K131468(ABBREVIATED)
ATTN: SUE  RU                     PHONE NO : 886 662309 99
2F, 17, DEYUANPI BLVD. DANUNG LI.,SE DECISION MADE: 06-MAY-14
TAINAN CITY    TW 73659           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6
ENCORE MEDICAL, L.P.              510(k) NO: K140904(SPECIAL)
ATTN: TEFFANY  HUTTO              PHONE NO : 512 834 6255   
9800 METRIC BLVD.                 SE DECISION MADE: 06-MAY-14
AUSTIN TX 78758                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK
BIO-RAD LABORATORIES              510(k) NO: K140916(TRADITIONAL)
ATTN: SUZANNE  PARSONS            PHONE NO : 949 598 1467   
9500 JERONIMO RD.                 SE DECISION MADE: 06-MAY-14
IRVINE CA 92618 2017              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
SHANDONG YIFAN PLASTIC PRODUCTS CO510(k) NO: K122656(TRADITIONAL)
ATTN: LING  ZHU                   PHONE NO : 909 548 4828   
12390 EAST END AVE.               SE DECISION MADE: 06-MAY-14
CHINO CA 91710                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GORE BIO-A WOUND MATRIX
W. L. GORE & ASSOCIATES, INC.     510(k) NO: K132397(TRADITIONAL)
ATTN: BARBARA L SMITH, RAC        PHONE NO : 410 506 8189   
301 AIRPORT RD.                   SE DECISION MADE: 07-MAY-14
ELKTON MD 21921                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM
FLUOPTICS                         510(k) NO: K132475(TRADITIONAL)
ATTN: MICHAEL A DANIEL            PHONE NO : 415 407 0223   
8 SNOWBERRY COURT                 SE DECISION MADE: 07-MAY-14
ORINDA CA 94563                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ULTRAPURE GAS LINE FILTER
ORIGIO, INC                       510(k) NO: K132870(TRADITIONAL)
ATTN: JOHN  CLAY                  PHONE NO : 856 762 2000   
2400 HUNTERS WAY                  SE DECISION MADE: 07-MAY-14
CHARLOTTESVILLE VA 22911          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EVOS MINI-FRAGMENT PLATING SYSTEM
SMITH & NEPHEW, INC.              510(k) NO: K140814(SPECIAL)
ATTN: SAMANTHA  STAUBACH          PHONE NO : 901 399 6132   
1450 BROOKS RD.                   SE DECISION MADE: 07-MAY-14
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH
SOFRADIM PRODUCTION               510(k) NO: K140941(SPECIAL)
ATTN: CLARE  SANTULLI             PHONE NO : 203 492 7635   
60 MIDDLETON AVE                  SE DECISION MADE: 07-MAY-14
NORTH HAVEN CT 06473              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LUXER SHADED ZIRCONIA
CONTINENTAL DENTAL CERAMICS, INC. 510(k) NO: K140070(TRADITIONAL)
ATTN: JERRY  DOVIACK              PHONE NO : 310 618 8821   
1872 WESTERN WAY                  SE DECISION MADE: 07-MAY-14
TORRANCE CA 90501                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EXCELLA III-D SPINAL DEFORMITY SYSTEM
INNOVASIS, INC.                   510(k) NO: K140238(TRADITIONAL)
ATTN: MASHALL  MCCARTY            PHONE NO : 801 261 2236   
614 E 3900 S                      SE DECISION MADE: 07-MAY-14
SALT LAKE CITY UT 84107           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TRUE SPINAL FUSSION SYSTEM
INNOVATIVE SURGICAL DESIGNS       510(k) NO: K133690(TRADITIONAL)
ATTN: ED  MORRIS                  PHONE NO : 812 360 4598   
2660 E. 2ND STREET #10            SE DECISION MADE: 07-MAY-14
BLOOMINGTON IN 47401              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CARESITE LUER ACCESS DEVICE
B. BRAUN MEDICAL, INC.            510(k) NO: K140311(TRADITIONAL)
ATTN: KIMBERLY  SMITH             PHONE NO : 610 596 2326   
901 MARCON BLVD.                  SE DECISION MADE: 07-MAY-14
ALLENTOWN PA 18109 9341           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
BAXTER HEALTHCARE CORPORATION     510(k) NO: K133801(TRADITIONAL)
ATTN: THOMAS  SAMPOGNA            PHONE NO : 224 270 4307   
32650 N. WILSON ROAD              SE DECISION MADE: 07-MAY-14
ROUND LAKE IL 60073               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MRNA APPLIANCE
BIOMODELING SOLUTIONS, LLS        510(k) NO: K130067(ABBREVIATED)
ATTN: COLETTE  COZEAN, PH.D.      PHONE NO : 949 855 2885   
15455 NW GREENBRIER PARKWAY       SE DECISION MADE: 08-MAY-14
BEAVERTON OR 97006                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: STALIF C(R)
CENTINEL SPINE, INC.              510(k) NO: K133200(TRADITIONAL)
ATTN: JOHN  PARRY                 PHONE NO : 484 887 8813   
900 AIRPORT RD, STE #3B           SE DECISION MADE: 08-MAY-14
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ELECSYS CK-MB STAT IMMUNOASSAY
ROCHE DIAGNOSTICS                 510(k) NO: K140404(SPECIAL)
ATTN: KELLI  TURNER               PHONE NO : 317 521 4515   
9115 HAGUE ROAD                   SE DECISION MADE: 08-MAY-14
INDIANAPOLIS IN 46250   46250     510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SCINTILLATION GAMMA CAMERA
DDD-DIAGNOSTIC A/S                510(k) NO: K140206(TRADITIONAL)
ATTN: NEERGAARDS  VEJ 5E          PHONE NO : 45 45 768888
2970 HORSHOLM                     SE DECISION MADE: 08-MAY-14
DENMARK    DA DENMARK             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: HERMES MEDICAL IMAGING SUITE V5.4
HERMES MEDICAL SOLUTIONS, AB      510(k) NO: K140269(TRADITIONAL)
ATTN: JOAKIM  ARWIDSON            PHONE NO : 46 8 190325
SKEPPSBRON 44                     SE DECISION MADE: 08-MAY-14
STOCKHOLM    SW 111 30            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS
MEDICAL COMPRESSION SYSTEMS (DBN) 510(k) NO: K140755(SPECIAL)
ATTN: ADELY  LEVY                 PHONE NO : 972 462 66630
2 HA'ILAN ST. P.O. BOX 75         SE DECISION MADE: 08-MAY-14
OR-AKIVA    IS 30600              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FILTEK BULK FILL POSTERIOR RESTROATIVE
3M ESPE DENTAL PRODUCTS           510(k) NO: K141081(TRADITIONAL)
ATTN: SCOTT  ERICKSON             PHONE NO : 
2510 CONWAY AVENUE                SE DECISION MADE: 08-MAY-14
SAINT PAUL MN 55144 0000          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: NOBELACTIVE WIDE PLATFORM (WP)
NOBELBIOCARE AB                   510(k) NO: K133731(TRADITIONAL)
ATTN: PHUONG  NGUYEN              PHONE NO : 714 282 4800   
22715 SAVI RANCH PARKWAY          SE DECISION MADE: 08-MAY-14
YORBA LINDA CA 92887              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: 16 CH MULTIPURPOSE COIL VARIETY
NORAS RONTGEN-UND MEDIZINTECHNIK G510(k) NO: K140252(TRADITIONAL)
ATTN: ZAHED  SEDIGHIANI           PHONE NO : 49 931 2992717
LEIBNIZSTRASSE 4                  SE DECISION MADE: 08-MAY-14
HOCHBERG    GM 97204              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AAP LOQTEC(R) OLECRANON PLATE
AAP IMPLANTATE AG                 510(k) NO: K140607(TRADITIONAL)
ATTN: CHRISTIAN  ZIETSCH          PHONE NO : 49 307501 9193
LORENZWEG 5                       SE DECISION MADE: 08-MAY-14
BERLIN    GM 12099                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ASTHMA MONITOR AM3
ERESEARCH TECHNOLOGY              510(k) NO: K133722(TRADITIONAL)
ATTN: RICHARD A MILLER            PHONE NO : 215 282 5588   
1818 MARKET STREET, STE 1000      SE DECISION MADE: 08-MAY-14
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: YZ3 PORTABLE SLIT LAMP
SUZHOU 66 VISION TECH CO., LTD.   510(k) NO: K131711(TRADITIONAL)
ATTN: HONGLING  XIA               PHONE NO : 86 512 67770353
NO. 34 DARU LANE                  SE DECISION MADE: 09-MAY-14
SUZHOU, JIANGSU    CH 215005      510(k) STATEMENT
 
DEVICE: RITTER IMPLANT SYSTEM
RITTER IMPLANTS GMBH CO KG        510(k) NO: K131557(TRADITIONAL)
ATTN: RAYMOND  KELLY              PHONE NO : 603 809 7668   
57 LAZY BROOK RD                  SE DECISION MADE: 09-MAY-14
MONROE CT 06468                   510(k) STATEMENT
 
DEVICE: A9800 ANESTHESIA WORKSTATION
ORICARE, INC.                     510(k) NO: K131790(TRADITIONAL)
ATTN: KURTIS  MONTEGNA            PHONE NO : 215 538 2470   
1900 AM DRIVE                     SE DECISION MADE: 09-MAY-14
QUAKERTOWN PA 18951               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LEKSELL GAMMA KNIFE PERFEXION
ELEKTA INSTRUMENT AB              510(k) NO: K133565(TRADITIONAL)
ATTN: MATILDA  FORSBERG           PHONE NO : 011 468 58725400
KUNGSTENSGATAN 18                 SE DECISION MADE: 09-MAY-14
STOCKHOLM    SW S-103 93          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ADX4000W
DEXCOWIN CO., LTD                 510(k) NO: K134055(SPECIAL)
ATTN: CLAUDE  BERTHOIN            PHONE NO : 386 672 0450   
110 EAST GRANADA BLVD. SUITE 207  SE DECISION MADE: 09-MAY-14
ORMOND BEACH FL 32176             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CANDELA GENTLEMAX FAMILY OF LASER SYSTEM
CANDELA CORP.                     510(k) NO: K140122(TRADITIONAL)
ATTN: SAM  WADE                   PHONE NO : 508 358 7400   
530 BOSTON POST ROAD              SE DECISION MADE: 09-MAY-14
WAYLAND MA 01778                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ROSS RU SKIN DISCONTINUITIES
BIOTD, S.A.                       510(k) NO: K131176(TRADITIONAL)
ATTN: RICHARD  GILLIS             PHONE NO : 512 327 9997   
816 CONGRESS AVENUE - STE 1400    SE DECISION MADE: 12-MAY-14
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ENDOSEAL
LK CONSULTING GROUP USA, INC.     510(k) NO: K133054(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 202 5789   
2651 E CHAPMAN AVE STE 110        SE DECISION MADE: 12-MAY-14
FULLERTON CA 92831                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ENDOCEM ZR
MARUCHI                           510(k) NO: K133042(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 202 5789   
2651 E CHAPMAN AVE STE 110        SE DECISION MADE: 12-MAY-14
FULLERTON CA 92833                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TIANKANG DISPOSABLE SYRINGES WITH RE-USE PREVENTION FEATURE WITH OR WITHOUT NEEDLE
ANHUI TIANKANG MEDICAL PRODUCTS CO510(k) NO: K131531(TRADITIONAL)
ATTN: XIUMING  CHONG              PHONE NO : 86 550 7309149
NO. 20 SOUTH RENHE ROAD           SE DECISION MADE: 12-MAY-14
TIANCHANG CITY, ANHUI PROVINCE    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GALLIEON-1 MEDICAL LASER
FUTURE DEVICE AND TECHNOLOGY, INC 510(k) NO: K132529(TRADITIONAL)
ATTN: SOUNGDON  CHUNG             PHONE NO : 213 503 2127   
4322 WILSHIRE BLVD., SUITE 303    SE DECISION MADE: 12-MAY-14
LOS ANGELES CA 90010              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: S9 ELOUERA
RESMED CORP                       510(k) NO: K140124(TRADITIONAL)
ATTN: JIM  CASSI                  PHONE NO : 858 836 6081   
9001 Spectrum Center Boulevard -- SE DECISION MADE: 12-MAY-14
San Diego CA 92123                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
ZIMMER, INC.                      510(k) NO: K133378(TRADITIONAL)
ATTN: DAN  WILLIMAN               PHONE NO : 574 371 8065   
P.O. BOX 708                      SE DECISION MADE: 12-MAY-14
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SUPERCATH5
TOGO MEDIKIT CO., LTD.            510(k) NO: K140419(TRADITIONAL)
ATTN: IZUMI  MARUO                PHONE NO : 011 813381 8577
4-1-17 HONGO                      SE DECISION MADE: 12-MAY-14
BUNKYO-KU    JA 113-0033          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: 1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL
RESONANCE INNOVATIONS LLC         510(k) NO: K140606(SPECIAL)
ATTN: RANDALL  JONES              PHONE NO : 402 934 2650   
9840 S. 140TH ST.                 SE DECISION MADE: 12-MAY-14
OMAHA NE 68138 3693               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ZERONA
ERCHONIA CORPORATION              510(k) NO: K133718(TRADITIONAL)
ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   
33 EAGLE LANE                     SE DECISION MADE: 12-MAY-14
LITTLETON CO 80127                510(k) STATEMENT
 
DEVICE: DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000A
RAYENCE CO., LTD                  510(k) NO: K140056(SPECIAL)
ATTN: DAVE  KIM                   PHONE NO : 713 467 2607   
8310 BUFFALO SPEEDWAY             SE DECISION MADE: 13-MAY-14
HOUSTON TX 77025                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD)
EQUASHIELD MEDICAL LTD            510(k) NO: K132899(TRADITIONAL)
ATTN: RAYMOND J KELLY, IV         PHONE NO : 203 880 4091   
57 LAZY BROOK RD                  SE DECISION MADE: 13-MAY-14
MONROE CT 06468                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VERSACUT + TISSUE MORCELLATOR
LUMENIS LTD.                      510(k) NO: K133272(TRADITIONAL)
ATTN: YORAM  LEVY                 PHONE NO : 972 463888 37
31 HAAVODA ST.                    SE DECISION MADE: 13-MAY-14
BINYAMINA    IS 30500             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BIOMARC COAXIAL NEEDLE
CARBON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K133148(TRADITIONAL)
ATTN: ANDREW J ADAMS              PHONE NO : 651 653 8512   
1290 HAMMOND RD.                  SE DECISION MADE: 13-MAY-14
ST. PAUL MN 55110                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM
ZUMA DENTAL, LLC                  510(k) NO: K133206(TRADITIONAL)
ATTN: ALBERT  REGO                PHONE NO : 949 770 8710   
27001 LA PAZ ROAD, STE 312        SE DECISION MADE: 13-MAY-14
MISSION VIEJO CA 92691            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX
PENUMBRA, INC.                    510(k) NO: K133317(TRADITIONAL)
ATTN: SETH  SCHULMAN              PHONE NO : 510 748 3223   
1351 HARBOR BAY PKWY.             SE DECISION MADE: 13-MAY-14
ALAMEDA CA 94502                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT
FACET TECHNOLOGIES, LLC           510(k) NO: K140568(SPECIAL)
ATTN: JENNIFER  REGISTER          PHONE NO : 770 590 6455   
112 TOWN PARK DR. SUITE 300       SE DECISION MADE: 13-MAY-14
KENNESAW GA 30144                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP
AESCULAP, INC.                    510(k) NO: K140343(TRADITIONAL)
ATTN: KATHY A RACOSKY             PHONE NO : 610 984 9291   
3773 CORPORATE PARKWAY            SE DECISION MADE: 13-MAY-14
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VITREA IMAGE DENOISING SOFTWARE
VITAL IMAGES, INC.                510(k) NO: K140395(TRADITIONAL)
ATTN: PARTHIV  SHAH               PHONE NO : 952 487 9574   
5850 Opus Pkwy Ste 300            SE DECISION MADE: 13-MAY-14
MINNETONKA MN 55343               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A
RAYENCE CO., LTD                  510(k) NO: K140060(SPECIAL)
ATTN: DAVE  KIM                   PHONE NO : 713 467 2607   
8310 BUFFALO SPEEDWAY             SE DECISION MADE: 13-MAY-14
HOUSTON TX 77025                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ONE-PIECE PEEK FUSION IMPLANT
MTP SOLUTIONS LLC                 510(k) NO: K140970(SPECIAL)
ATTN: ROBERT  HOY                 PHONE NO : 614 448 6358   
124 SOUTH 600 WEST, SUITE 100     SE DECISION MADE: 13-MAY-14
LOGAN UT 84321                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE
BIOMET, INC.                      510(k) NO: K140622(TRADITIONAL)
ATTN: SUZANA  OTANO               PHONE NO : 305 269 6386   
56 EAST BELL DR.                  SE DECISION MADE: 13-MAY-14
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
SPINEFRONTIER, INC.               510(k) NO: K133153(SPECIAL)
ATTN: PAUL L SPEIDEL              PHONE NO : 978 323 3990   
500 CUMMINGS CENTER SUITE 3500    SE DECISION MADE: 14-MAY-14
BEVERLY MA 01915                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OMNIPORE CUSTOMIZED SURGICAL IMPLANTS
MATRIX SURGICAL HOLDINGS, LLC/MATR510(k) NO: K133046(TRADITIONAL)
ATTN: JULIE  STEPHENS             PHONE NO : 678 513 0693   
111 LAUREL RIDGE DR.              SE DECISION MADE: 14-MAY-14
ALPHARETTA GA 30004               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NEOPLATE SPINE ANTERIOR FIXATION SYSTEM
NEOORTHO PRODUCTOS ORTHOPEDICOS S/510(k) NO: K132653(TRADITIONAL)
ATTN: TARA  CONRAD                PHONE NO : 305 206 6777   
18851 NE 29TH AVE 720             SE DECISION MADE: 14-MAY-14
AVENTURA FL 33180                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MSP METATARSAL SHORTENING SYSTEM
NEXTREMITY SOLUTIONS, INC.        510(k) NO: K140724(TRADITIONAL)
ATTN: JORGE A MONTOYA             PHONE NO : 732 383 7901   
54 BROAD STREET, STE 200          SE DECISION MADE: 14-MAY-14
RED BANK NJ 07701                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MULTIFIX S KNOTLESS FIXATION SYSTEM
ARTHROCARE CORPORATION            510(k) NO: K140604(SPECIAL)
ATTN: MITCHELL  DHORITY           PHONE NO : 512 358 5995   
7000 West William Cannon Drive    SE DECISION MADE: 14-MAY-14
Austin TX 78735                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR
BECTON DICKINSON & CO.            510(k) NO: K140591(SPECIAL)
ATTN: JOHN  ROBERTS               PHONE NO : 201 847 5473   
1 BECTON DR. MC237                SE DECISION MADE: 14-MAY-14
FRANKLIN LAKES NJ 07417 1885      510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K133700(TRADITIONAL)
ATTN: ELENA  NIEVES               PHONE NO : 508 683 4347   
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 14-MAY-14
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SALVATION OSTEOPENIC SCREW
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K140408(TRADITIONAL)
ATTN: VAL  MYLES                  PHONE NO : 901 290 5162   
1023 CHERRY ROAD                  SE DECISION MADE: 14-MAY-14
MEMPHIS TN 38117                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV DIAGNOSTIC ULTRASOUND SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K141010(TRADITIONAL)
ATTN: WU  ZICUI                   PHONE NO : 867 558188 5658
KEJI 12TH ROAD SOUTH HI-TECH INDUSSE DECISION MADE: 14-MAY-14
SHENZHEN    CH 518057             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM
IMAGING SCIENCES INTERNATIONAL    510(k) NO: K133620(TRADITIONAL)
ATTN: RUTH  PUI                   PHONE NO : 215 997 5666   
1910 NORTH PENN RD.               SE DECISION MADE: 14-MAY-14
HATFIELD PA 19454                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: STOP U (PACKED BLACK USA); STOP U (PACKED WHITE USA)
POLLOGEN LTD                      510(k) NO: K140255(TRADITIONAL)
ATTN: JONATHAN S KAHAN            PHONE NO : 202 637 5794   
555 THIRTEENTH ST, NW             SE DECISION MADE: 14-MAY-14
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO
ORIGIO A/S                        510(k) NO: K133912(TRADITIONAL)
ATTN: TOVE  KJAER                 PHONE NO : 45 467902 00
Knardrupvej 2                     SE DECISION MADE: 14-MAY-14
Maaloev    DK DK-2760             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FETAL MONITORS
GUANGDONG BIOLIGHT MEDITECH CO., L510(k) NO: K131941(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 212281 5850
P.O. BOX 120-119                  SE DECISION MADE: 15-MAY-14
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EXTRICARE
DEVON MEDICAL INC.                510(k) NO: K132225(TRADITIONAL)
ATTN: RUTH  WU                    PHONE NO : 866 446 0092   
1100 FIRST AVE, STE 202           SE DECISION MADE: 15-MAY-14
KING OF PRUSSIA PA 19406          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RXG DISTRACTION SYSTEM
KLS-MARTIN L.P.                   510(k) NO: K133304(TRADITIONAL)
ATTN: JENNIFER  DAMATO            PHONE NO : 800 625 1557   
11201 Saint Johns Industrial Pkwy SE DECISION MADE: 15-MAY-14
Jacksonville FL 32246             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: 6VT-D ULTRASOUND TRANSDUCER
GE VINGMED ULTRASOUND AS          510(k) NO: K141093(TRADITIONAL)
ATTN: BRYAN  BEHN                 PHONE NO : 473 302110 0
STRANDPROMENADEN 45               SE DECISION MADE: 15-MAY-14
HORTEN    NO N-3183               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FIREFLY
FIRSTKIND LIMITED                 510(k) NO: K134001(TRADITIONAL)
ATTN: SHEILA  HEMEON-HEYER        PHONE NO : 413 549 7463   
231 FAIRBANKS STREET              SE DECISION MADE: 15-MAY-14
WEST BOYLSTON MA 01583            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INFUSET FLOW CONTROL EXTENSION SET
EMED TECHNOLOGIES CORPORATION     510(k) NO: K140133(TRADITIONAL)
ATTN: PETER  KOLLINGS             PHONE NO : 916 932 0071   
1264 Hawks Flight Ct Ste 200      SE DECISION MADE: 15-MAY-14
EL DORADO HILLS CA 95762          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS
GE MEDICAL SYSTEMS ULTRASOUND & PR510(k) NO: K133664(TRADITIONAL)
ATTN: CHRIS  PAULIK               PHONE NO : 262 548 2010   
3030 OHMEDA DRIVE                 SE DECISION MADE: 15-MAY-14
MADISON WI 53718 6704             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: XGEO GR40CW
SAMSUNG ELECTRONICS CO., LTD.     510(k) NO: K140235(TRADITIONAL)
ATTN: JEONGPYO  HONG              PHONE NO : 82 31 2004202
129, SAMSUNG-RO YEONGTONG-GU      SE DECISION MADE: 15-MAY-14
SUWON-SI, GYEONGGI-DO    KS 443742510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT
SONENDO, INC.                     510(k) NO: K133752(TRADITIONAL)
ATTN: DAN  MILLER                 PHONE NO : 949 766 3636   
26061 MERIT CIRCLE, SUITE 101     SE DECISION MADE: 15-MAY-14
LAGUNA HILLS CA 92653             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM
MEDI-GLOBE CORPORATION            510(k) NO: K133763(TRADITIONAL)
ATTN: SCOTT  KARLER               PHONE NO : 480 987 2772   
110 WEST ORION  STREET            SE DECISION MADE: 15-MAY-14
TEMPE AZ 85283                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT
BOSTON SCIENTIFIC                 510(k) NO: K140329(SPECIAL)
ATTN: MARK  MURPHY                PHONE NO : 763 494 2377   
ONE SCIMED PLACE                  SE DECISION MADE: 15-MAY-14
MAPLE GROVE MN 55311 1566         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SALVATION BEAMS AND BOLTS SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K140741(TRADITIONAL)
ATTN: LESLIE  FITCH               PHONE NO : 901 867 4120   
1023 CHERRY ROAD                  SE DECISION MADE: 15-MAY-14
MEMPHIS TN 38117                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K140952(SPECIAL)
ATTN: LESLIE  FITCH               PHONE NO : 901 867 4120   
1023 CHERRY ROAD                  SE DECISION MADE: 15-MAY-14
MEMPHIS TN 38117                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RAY STATION
RAYSEARCH LABORATORIES AB         510(k) NO: K140187(TRADITIONAL)
ATTN: LADAN  AMIRI                PHONE NO : 460 708604 006
SVEAVAGEN 25, PLAN 9              SE DECISION MADE: 15-MAY-14
STOCKHOLM    SW SE-111 34         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SMITH & NEPHEW CANNULATED CAPTURED SCREW
SMITH & NEPHEW, INC.              510(k) NO: K133662(TRADITIONAL)
ATTN: KATHERINE  MARCACCIO        PHONE NO : 508 261 3602   
150 MINUTEMAN RD.                 SE DECISION MADE: 15-MAY-14
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NXSTAGE PUREFLOW SL
NXSTAGE MEDICAL, INC.             510(k) NO: K140571(SPECIAL)
ATTN: MARY L STROUMBOS            PHONE NO : 978 687 4872   
350 MERRIMACK STREET              SE DECISION MADE: 15-MAY-14
LAWRENCE MA 01843                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM
AROBELLA MEDICAL, LLC             510(k) NO: K131096(TRADITIONAL)
ATTN: MATTHEW  BERSCHEID          PHONE NO : 952 345 6840   
5929 Baker Road Suite 470         SE DECISION MADE: 16-MAY-14
Minnetonka MN 55345               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NUVASIVE NVM5 SYSTEM
NUVASIVE, INCORPORATED            510(k) NO: K132694(TRADITIONAL)
ATTN: SHEILA  BRUSCHI             PHONE NO : 858 320 4515   
7475 LUSK BOULEVARD               SE DECISION MADE: 16-MAY-14
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BIOPSY PIPETTES
RESEARCH INSTRUMENTS LTD.         510(k) NO: K133257(TRADITIONAL)
ATTN: DAVID  LANSDOWNE            PHONE NO : 44 1326 372753
BICKLAND WATER INDUSTRIAL PARK FALSE DECISION MADE: 16-MAY-14
 CORNWALL    UK TR 11 4TA         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VITAL SIGNS MONITOR
MINDRAY NORTH AMERICA             510(k) NO: K132037(ABBREVIATED)
ATTN: RUSSELL  OLSEN              PHONE NO : 201 995 8391   
800 MACARTHUR BLVD                SE DECISION MADE: 16-MAY-14
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: KLASSIC KNEE TIBIAL STEM EXTENSION
TOTAL JOINT ORTHOPEDICS, INC.     510(k) NO: K140942(TRADITIONAL)
ATTN: JEAN  WHEELER               PHONE NO : 801 486 6070   
1567 E. STRATFORD AVE.            SE DECISION MADE: 16-MAY-14
SALT LAKE CITY UT 84106           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RESCAN
RESMED LTD                        510(k) NO: K140054(TRADITIONAL)
ATTN: JIM  CASSI                  PHONE NO : 858 836 6081   
9001 SPECTRUM CENTER BOULEVARD    SE DECISION MADE: 16-MAY-14
SAN DIEGO CA 92123                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VSCAN WITH DUAL PROBE
GE MEDICAL SYSYEMS ULTRASOUND & PR510(k) NO: K140693(TRADITIONAL)
ATTN: TRACEY  ORTIZ               PHONE NO : 262 676 6120   
9900 INNOVATION DRIVE             SE DECISION MADE: 16-MAY-14
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE
APTUS ENDOSYSTEMS                 510(k) NO: K141041(SPECIAL)
ATTN: BURT  GOODSON               PHONE NO : 408 530 9050   
271 GIBRALTAR DR                  SE DECISION MADE: 16-MAY-14
SUNNYVALE CA 94089 0000           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LUMENA FH HAIR REMOVAL SYSTEM
SHASER, INC.                      510(k) NO: K140631(SPECIAL)
ATTN: ANTHONY  BURNS              PHONE NO : 339 927 2599   
10 Maguire Rd Ste 120             SE DECISION MADE: 16-MAY-14
Lexington MA 02421                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TEMPUS PRO EXTENDED FEATURES
REMOTE DIAGNOSTIC TECHNOLOGIES LTD510(k) NO: K133988(ABBREVIATED)
ATTN: LEIGH  CORNOCK              PHONE NO : 44 1256 362409
THE OLD COACH HOUSE, THE AV. FARLESE DECISION MADE: 16-MAY-14
HAMPSHIRE    UK RG25 2HT          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AXERA RX ACCESS SYSTEM
ARSTASIS, INC.                    510(k) NO: K140287(TRADITIONAL)
ATTN: GRACE  LI                   PHONE NO : 650 261 8039   
740 BAY RD                        SE DECISION MADE: 16-MAY-14
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DMS 300-2W HOLTER ECG RECORDER
DIAGNOSTIC MONITORING SOFTWARE    510(k) NO: K133014(SPECIAL)
ATTN: WILLIAM  PARSONS            PHONE NO : 714 953 2653   
290 Kingsbury Grade # 3           SE DECISION MADE: 19-MAY-14
Stateline NV 89449                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MAXIO
PERFINT HEALTHCARE PVT LTD        510(k) NO: K132108(TRADITIONAL)
ATTN: JANICE  HOGAN               PHONE NO : 267 675 4600   
11665 AVENA PLACE, STE 203        SE DECISION MADE: 19-MAY-14
SAN DIEGO CA 92128                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PERSYST 12 ( P12)  EGG REVIEW AND ANALYSIS SOFTWARE
PERSYST DEVELOPMENT CORPORATION   510(k) NO: K133793(TRADITIONAL)
ATTN: DARI  DARABBEIGI            PHONE NO : 858 461 4542   
12625 HIGH BLUFF DRIVE, SUITE 213 SE DECISION MADE: 19-MAY-14
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CS2 MULTI-HOLE ACETABULAR SHELL
CONSENSUS ORTHOPEDICS, INC        510(k) NO: K141043(SPECIAL)
ATTN: MATTHEW M HULL              PHONE NO : 916 355 7100   
1115 WINFIELD WAY SUITE 100       SE DECISION MADE: 19-MAY-14
EL DORADO HILLS CA 95762 9623     510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VIEWFLEX XTRA ICE CATHETER
IRVINE BIOMEDICAL, INC. A ST.JUDE 510(k) NO: K133853(TRADITIONAL)
ATTN: JENNIFER  CORREA            PHONE NO : 949 769 5053   
2375 MORSE AVENUE                 SE DECISION MADE: 19-MAY-14
IRVINE CA 92614                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: THUNDERBEAT
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K132703(TRADITIONAL)
ATTN: GRAHAM  BAILLIE             PHONE NO : 508 804 2738   
136 TURNPIKE ROAD REGULATORY AFFAISE DECISION MADE: 19-MAY-14
SOUTHBOROUGH MA 01772             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K141015(SPECIAL)
ATTN: MARKUS  STACHA              PHONE NO : 49 7031 4632840
HEWLETT-PACKARD STR.2             SE DECISION MADE: 19-MAY-14
BOEBLINGEN    GM D 71034          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NXSTAGE SYSTEM ONE
NXSTAGE MEDICAL, INC.             510(k) NO: K140526(TRADITIONAL)
ATTN: MARY LOU  STROUMBOS         PHONE NO : 978 687 4872   
350 MERRIMACK STREET              SE DECISION MADE: 19-MAY-14
LAWRENCE MA 01843                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OSTEOSPAN MORPHEUS
BIOGENNIX, LLC                    510(k) NO: K132377(TRADITIONAL)
ATTN: ELAINE  DUNCAN              PHONE NO : 715 549 6035   
P.O. BOX 560                      SE DECISION MADE: 20-MAY-14
STILLWATER MN 55082               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NAMSA CHEMICAL PROCESS
NORTH AMERICAN SCIENCE ASSOC., INC510(k) NO: K132291(TRADITIONAL)
ATTN: JULIE  WHEELER              PHONE NO : 419 666 9455   
6750 WALES RD.                    SE DECISION MADE: 20-MAY-14
NORTHWOOD OH 43619                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ACUMED SUTURE ANCHOR SYSTEM
ACUMED, LLC                       510(k) NO: K140925(SPECIAL)
ATTN: LINO  TSAI                  PHONE NO : 503 207 1370   
5885 NW CORNELIUS PASS ROAD       SE DECISION MADE: 20-MAY-14
HILLSBORO OR 97124                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: Y WIRE 2
SAFEWIRE, LLC                     510(k) NO: K140576(TRADITIONAL)
ATTN: STEPHEN W INGLESE           PHONE NO : 954 830 0051   
520 BUTTERNUT DR, #8 PMB#256      SE DECISION MADE: 20-MAY-14
HOLLAND MI 49424                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GENERAL AND PLASTIC SURGERY
SCION MEDICAL TECHNOLOGIES LLC    510(k) NO: K140835(SPECIAL)
ATTN: CHRIS  LEWIS                PHONE NO : 617 209 5629   
90 Oak St                         SE DECISION MADE: 20-MAY-14
Newton MA 02464                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE
MEDTRONIC, INC.                   510(k) NO: K140165(TRADITIONAL)
ATTN: JACQUELINE A HAUGE          PHONE NO : 763 514 9967   
7611 NORTHLAND DRIVE              SE DECISION MADE: 20-MAY-14
MINNEAPOLIS MN 55428              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BD VIPER LT SYSTEM
BECTON, DICKINSON AND COMPANY     510(k) NO: K140447(TRADITIONAL)
ATTN: SHERMA  WINSTON             PHONE NO : 410 316 4145   
7 LOVETON CIRCLE                  SE DECISION MADE: 20-MAY-14
SPARKS MD 21152                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE
OSTEOSYMBIONICS, LLC              510(k) NO: K133082(TRADITIONAL)
ATTN: NICHOLAS  WLKINS            PHONE NO : 216 881 8500   
1768 EAST 25TH STREET SUITE 316   SE DECISION MADE: 20-MAY-14
CLEVELAND OH 44114                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
SPINEART                          510(k) NO: K140948(SPECIAL)
ATTN: FRANCK  PENNESI             PHONE NO : 41 22 7994025
INTERNATIONAL CENTER COINTRIN 20 RSE DECISION MADE: 20-MAY-14
GENEVA    SZ 1215                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PRIME ZOOM STRETCHER
STRYKER CORPORATION               510(k) NO: K140095(TRADITIONAL)
ATTN: MATTHEW W JORDAN            PHONE NO : 269 389 6604   
3800 E. CENTRE AVE                SE DECISION MADE: 20-MAY-14
PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: ASAP OTC WOUND DRESSING GEL
ABL MEDICAL, LLC                  510(k) NO: K140483(SPECIAL)
ATTN: CALLEY  HERZOG              PHONE NO : 720 883 3633   
400 N. WASHINGTON ST., STE 100    SE DECISION MADE: 20-MAY-14
ALEXANDRIA VA 22314               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
ELLIPSE TECHNOLOGIES, INC.        510(k) NO: K141023(SPECIAL)
ATTN: REBECCA  SHELBURNE          PHONE NO : 949 837 3600   
13900 Alton Pkwy Ste 123          SE DECISION MADE: 20-MAY-14
Irvine CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CARDIOHELP SYSTEM
MAQUET CARDIOPULMONARY AG         510(k) NO: K133598(TRADITIONAL)
ATTN: HELDER A SOUSA              PHONE NO : 973 709 7465   
45 BARBOUR POND DRIVE             SE DECISION MADE: 21-MAY-14
WAYNE NJ 07470                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MOTEX POWDERED NITRILE SURGICAL GLOVES
SHANGHAI MOTEX HEALTHCARE CO., LTD510(k) NO: K132802(TRADITIONAL)
ATTN: JEN  KE-MIN                 PHONE NO : 86 21 59799888
NO. 369, JIASONG ZHONG ROAD HUAXINSE DECISION MADE: 21-MAY-14
SHANGHAI    CH 201708             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEM
XIAMEN DOUBLE ENGINE MEDICAL MATER510(k) NO: K131609(TRADITIONAL)
ATTN: DA  ZENG                    PHONE NO : 86 0592 6087078
NO. 218, HOUXIANG ROAD HAICANG DISSE DECISION MADE: 21-MAY-14
XIAMEN, FUJIAN    CH 361022       510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SOLUM IV BONE VOID FILLER
SPINESMITH PARTNERS, LLP          510(k) NO: K132470(TRADITIONAL)
ATTN: CLIFTON  NAIVAR             PHONE NO : 512 637 2068   
93 RED RIVER ST.                  SE DECISION MADE: 21-MAY-14
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA)
HARVEST DENTAL PRODUCTS, LLC      510(k) NO: K132937(TRADITIONAL)
ATTN: ANDREW  ROWE                PHONE NO : 714 674 7400   
4281 EXPRESS LANE STE # L4094     SE DECISION MADE: 21-MAY-14
SARASOTA FL 34238                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM
COOK INCORPORATED                 510(k) NO: K140169(TRADITIONAL)
ATTN: THOMAS J KARDOS             PHONE NO : 724 845 8621   
750 DANIELS WAY                   SE DECISION MADE: 21-MAY-14
BLOOMINGTON IN 47404              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT
BTG INTERNATIONAL, INC.           510(k) NO: K140151(TRADITIONAL)
ATTN: JOCELYN  KERSTEN            PHONE NO : 425 415 3132   
11911 NORTH CREEK PARKWAY S       SE DECISION MADE: 21-MAY-14
BOTHELL WA 98011                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TRINICA ANTERIOR LUMBAR PLATE SYSTEM
ZIMMER SPINE, INC.                510(k) NO: K140611(TRADITIONAL)
ATTN: DONNA M SEMLAK              PHONE NO : 952 857 5643   
7375 Bush Lake Rd                 SE DECISION MADE: 21-MAY-14
Minneapolis MN 55439              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NOVOFINE PLUS 32G 4 MM
NOVO NORDISK INC.                 510(k) NO: K133738(TRADITIONAL)
ATTN: RICK  SPRING                PHONE NO : 609 987 5046   
P.O. BOX 846                      SE DECISION MADE: 21-MAY-14
PLAINSBORO NJ 08536               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SILC FIXATION SYSTEM
GLOBE MEDICAL, INC.               510(k) NO: K133482(TRADITIONAL)
ATTN: CHRISTINA  KICHULA          PHONE NO : 610 930 1800   
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 21-MAY-14
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GALAFLEX MESH
TEPHA, INC.                       510(k) NO: K140533(TRADITIONAL)
ATTN: MARY P LEGRAW               PHONE NO : 781 357 1709   
99 HAYDEN, SUTIE 360              SE DECISION MADE: 21-MAY-14
LEXINGTON MA 02421                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NO TOUCH+FOREHEAD NTF 3000 THERMOMETER
KAZ USA, INC (A SUBSIDIARY OF KAZ 510(k) NO: K134043(TRADITIONAL)
ATTN: RAJ  KASBEKAR               PHONE NO : 508 490 7280   
250 TURNPIKE ROAD                 SE DECISION MADE: 21-MAY-14
SOUTHBOROUGH MA 01772             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: HYGEDENT ALGINATE IMPRESSION MATERIAL
HYGEDENT INC                      510(k) NO: K140074(TRADITIONAL)
ATTN: MIKE  GU                    PHONE NO : 862 062321 333
7TH FLOOR,JINGUI BUSINESS BUILDINGSE DECISION MADE: 21-MAY-14
GUANGZHOU, GUANGDONG    CH 510420 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO
MEDIKRO OY                        510(k) NO: K133428(TRADITIONAL)
ATTN: MIKKO  ELORANTA             PHONE NO : 358 447777 021
KELLOLAHDENTIE 27                 SE DECISION MADE: 21-MAY-14
KUOPIO    FI FI-70460             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K131588(TRADITIONAL)
ATTN: SALLY  MAHER                PHONE NO : 949 250 6465   
ONE EDWARDS WAY                   SE DECISION MADE: 22-MAY-14
IRVINE CA 92614                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SYNERGY
ODONTIT SA                        510(k) NO: K123876(TRADITIONAL)
ATTN: BLIX  WINSTON               PHONE NO : 301 607 9185   
2600 MULLINIX MILL ROAD           SE DECISION MADE: 22-MAY-14
MT AIRY MD 21771                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EV1000 CLINICAL PLATFORM
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K131892(TRADITIONAL)
ATTN: SALLY  MAHER                PHONE NO : 949 250 6465   
ONE EDWARDS WAY                   SE DECISION MADE: 22-MAY-14
IRVINE CA 92614                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE
SOL-MILLENNIUM MEDICAL, INC.      510(k) NO: K132681(TRADITIONAL)
ATTN: JIM  BARLEY                 PHONE NO : 949 433 3058   
5415 SUGARLOAF PKWY, STE 2203     SE DECISION MADE: 22-MAY-14
LAWRENCEVILLE GA 30043            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER
MATERIALISE N.V.                  510(k) NO: K140027(TRADITIONAL)
ATTN: OLIVER  CLEMENS             PHONE NO : 32 1674 4537
TECHNOLOGIELAAN 15                SE DECISION MADE: 22-MAY-14
LEUVEN    BE 3001                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ZOLL X SERIES
ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K133269(TRADITIONAL)
ATTN: TANMAY B SHUKLA             PHONE NO : 978 421 9171   
269 MILL ROAD                     SE DECISION MADE: 22-MAY-14
CHELMSFORD MA 01824 4105          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ISE INDIRECT NA, K, C1 FOR GEN 2
ROCHE DIAGNOSTICS                 510(k) NO: K140373(TRADITIONAL)
ATTN: DAVID  TRIBBETT             PHONE NO : 317 521 2964   
9115 HAGUE ROAD                   SE DECISION MADE: 22-MAY-14
INDIANAPOLIS IN 46250             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NEXUS NIS-6P LUER ACTIVATED DEVICE
NEXUS MEDICAL LLC                 510(k) NO: K133351(TRADITIONAL)
ATTN: HEATHER  TURNER             PHONE NO : 913 451 2234   
1113 STRANG LINE ROAD             SE DECISION MADE: 22-MAY-14
LENEXA KS 66215                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FT
SAM MEDICAL PRODUCTS              510(k) NO: K133121(TRADITIONAL)
ATTN: JACK  MCCUTCHEON            PHONE NO : 503 639 5474   
27350 SW 95TH AVE STE 3038        SE DECISION MADE: 22-MAY-14
Wilsonville OR 97070              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ANS1 SOFTWARE
LD TECHNOLOGY LLC                 510(k) NO: K140412(SPECIAL)
ATTN: ALBERT  MAAREK              PHONE NO : 305 379 9900   
100 Biscayne Blvd Ste 502         SE DECISION MADE: 22-MAY-14
Miami FL 33132                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EVEREST SPINAL SYSTEM
K2M, LLC                          510(k) NO: K140529(SPECIAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DRIVE SE               SE DECISION MADE: 22-MAY-14
LEESBURG VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K140454(TRADITIONAL)
ATTN: REGINA  HOLMES              PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 22-MAY-14
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CARPENTIER BI-CAVAL FEMORAL CANNULA
MEDTRONIC, INC.                   510(k) NO: K140192(TRADITIONAL)
ATTN: JACQUELINE A HAUGE          PHONE NO : 763 514 9967   
7611 NORTHLAND DRIVE              SE DECISION MADE: 22-MAY-14
BROOKLYN PARK MN 55428            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL
RANDOX LABORATORIES LIMITED       510(k) NO: K140522(TRADITIONAL)
ATTN: PAULINE  ARMSTRONG          PHONE NO : 44 289442 2413
55 DIAMOND RD.                    SE DECISION MADE: 22-MAY-14
CRUMLIN, CO.ANTRIM    UK BT29 4QY 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE
THERMO FISHER SCIENTIFIC (LIFE TEC510(k) NO: K141220(SPECIAL)
ATTN: NIKKI  ARORA                PHONE NO : 656 362927 9
BLK 33, MARSILING INDUSTRIAL, ESTASE DECISION MADE: 22-MAY-14
SINGAPORE    SN 739256            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SALVATION 3DI PLATING SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K140792(TRADITIONAL)
ATTN: LESLIE  FITCH               PHONE NO : 901 867 4120   
1023 CHERRY ROAD                  SE DECISION MADE: 22-MAY-14
MEMPHIS TN 38117                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ALPHA-STIM MODEL ALPHA-STIM 100; BODY-STIM, BEST-RSI, BIOMODULATOR, MODEL BEST-PRO1; BEST-AV1; INTERX5000 MODEL INTERX50
AVAZZIA, INC.                     510(k) NO: K123099(TRADITIONAL)
ATTN: TAMMY  LAHUTSKY             PHONE NO : 214 575 2820   
13140 Coit Rd Ste 515             SE DECISION MADE: 23-MAY-14
DALLAS TX 75240                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MYSPINE PEDICLE SCREW PLACEMENT GUIDES
MEDACTA INTERNATIONAL             510(k) NO: K132788(TRADITIONAL)
ATTN: ADAM  GROSS                 PHONE NO : 805 322 3289   
4725 CALLE QUETZAL, UNIT B        SE DECISION MADE: 23-MAY-14
CAMARILLO CA 93012                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VIBRALUNG ACOUSTICAL PERCUSSOR
WESTMED, INC.                     510(k) NO: K133057(TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
5580 S. NOGALES HIGHWAY           SE DECISION MADE: 23-MAY-14
TUCSON AZ 85706   85706           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MEDWS SOFTWARE (VARIANTS MEDVIEW, MEDDIAG, MEDMAMMO)
MEDECOM SARL                      510(k) NO: K132684(ABBREVIATED)
ATTN: CYNTHIA  COTTEREAU          PHONE NO : 33 545 321884
2 RUE QUENOT                      SE DECISION MADE: 23-MAY-14
JARNAC    FR 16 200               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NUTRA LIGHT BLUE
NUTRA LUXE MD, LLC                510(k) NO: K132838(TRADITIONAL)
ATTN: JILL  CREASY                PHONE NO : 775 622 9591   
5575 SANTA ROSA CT.               SE DECISION MADE: 23-MAY-14
SPARKS NV 89436                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET
TELEFLEX MEDICAL, INC.            510(k) NO: K133173(TRADITIONAL)
ATTN: LORI  PFOHL                 PHONE NO : 919 491 8960   
2917 WECK DR.                     SE DECISION MADE: 23-MAY-14
RESEARCH TRIANGLE PARK NC 27709   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VIVID T8/VIVID T8 PRO
GE HEALTHCARE                     510(k) NO: K141067(TRADITIONAL)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214   
9900 INNOVATION DRIVE             SE DECISION MADE: 23-MAY-14
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MINNIE
ELETTRONICA VALSERIANA SRL        510(k) NO: K133405(TRADITIONAL)
ATTN: SERGIO  GHERSINI            PHONE NO : 390 3572 6301
VIA SAN CARLO 45/47               SE DECISION MADE: 23-MAY-14
CASNIGO    IT I-24020             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: APLIO ARTIDA, V3.2
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K140729(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 669 7459   
2441 MICHELLE DR. P.O. BOX 2068   SE DECISION MADE: 23-MAY-14
TUSTIN CA 92781 2068              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: TIGHTRAIL MINI
SPECTRANETICS, INC.               510(k) NO: K141131(SPECIAL)
ATTN: CHRISTOPHER  MCLELLAN       PHONE NO : 719 447 2385   
9965 FEDERAL DRIVE                SE DECISION MADE: 23-MAY-14
COLORADO SPRINGS CO 80921         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CORCAM HEART MONITOR
CORCAM TECHNOLOGIA, SA            510(k) NO: K140548(TRADITIONAL)
ATTN: JENNIFER A DAUDELIN         PHONE NO : 703 562 9800   
575 EIGHTH AVE, STE 1212          SE DECISION MADE: 23-MAY-14
NEW YORK NY 10018                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FMWAND HANDPIECE SE
DOMAIN SURGICAL, INC.             510(k) NO: K140384(TRADITIONAL)
ATTN: CURTIS  JENSEN              PHONE NO : 801 924 4950   
1370 SOUTH 2100 EAST              SE DECISION MADE: 23-MAY-14
SALT LAKE SITY UT 84108           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SHERPA PAK TRANSPORTER
PARAGONIX TECHNOLOGIES, INC.      510(k) NO: K133694(TRADITIONAL)
ATTN: LEO  BASTA                  PHONE NO : 617 834 9866   
93 BENEFIT STREET                 SE DECISION MADE: 23-MAY-14
PROVIDENCE RI 02904               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ACESSA GUIDANCE SYSTEM
HALT MEDICAL INC.                 510(k) NO: K132744(TRADITIONAL)
ATTN: CLARISA  TATE               PHONE NO : 925 271 0626   
131 Sand Creek Road, Suite B      SE DECISION MADE: 27-MAY-14
Brentwood CA 94513                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM
CUREXO TECHNOLOGY CORPORATION     510(k) NO: K140038(TRADITIONAL)
ATTN: GLEN  EMELOCK               PHONE NO : 781 665 9893   
32 HARRISON ST.                   SE DECISION MADE: 27-MAY-14
MELROSE MA 02176                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
CONFORMIS, INC.                   510(k) NO: K140423(TRADITIONAL)
ATTN: AMITA  SHAH                 PHONE NO : 781 345 9164   
28 Crosby Dr                      SE DECISION MADE: 27-MAY-14
Bedford MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SKYHAWK INTERBODY FUSION SYSTEM
ORTHOFIX INC.                     510(k) NO: K140709(TRADITIONAL)
ATTN: TROY  BROOKS                PHONE NO : 214 937 2047   
3451 Plano Parkway                SE DECISION MADE: 27-MAY-14
Lewisville TX 75056               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: A-DEC/W&H ELECTRIC HANDPIECE MOTOR
A-DEC, INC.                       510(k) NO: K133776(SPECIAL)
ATTN: BONNIE  DUNDAS              PHONE NO : 503 538 9471   
2601 CRESTVIEW AVE.               SE DECISION MADE: 28-MAY-14
NEWBERG OR 97132                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: VALENTINE STEEL WHEELCHAIR
VALENTINE INTL. LTD.              510(k) NO: K130017(TRADITIONAL)
ATTN: JEN  KE-MIN                 PHONE NO : 886 286926 662
8TH FL., NO. 149, SEC. 2, TA TUNG SE DECISION MADE: 28-MAY-14
NEW TAIPEI CITY    TW 221         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ELASTIC IMPRESSION MATERIAL
RIZHAO HUGE DENTAL INDUSTRY CO., L510(k) NO: K133071(TRADITIONAL)
ATTN: LEON  LU                    PHONE NO : 877 202 1588   
3500 SOUTH DUPONT HIGHWAY         SE DECISION MADE: 28-MAY-14
DOVER DE 19901                    510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SPIROL  BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)
EPIMED INTERNATIONAL, INC.        510(k) NO: K133316(TRADITIONAL)
ATTN: PRESTON L FRAISER           PHONE NO : 518 725 0209   
141 SAL LANDRIO DR. CROSSROADS BUSSE DECISION MADE: 28-MAY-14
JOHNSTOWN NY 12095                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RAYSERT PLUS INJECTOR
RAYNER INTRAOCULAR LENSES LTD.    510(k) NO: K141091(SPECIAL)
ATTN: JULIETTE  COOK              PHONE NO : 44 1273 205401
1-2 SACKVILLE TRADING ESTATE, SACKSE DECISION MADE: 28-MAY-14
HOVE, EAST SUSSEX    UK BN3 7AN   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M
HARTALEGA SDN BHD                 510(k) NO: K133953(TRADITIONAL)
ATTN: NURUL AISYAH  KONG BT ABDULLPHONE NO : 603 327102 77
NO. 7, KAWASAN PERUSAHAAN SURIA   SE DECISION MADE: 28-MAY-14
BESTARI JAYA, SELANGOR    MY 45600510(k) STATEMENT
 
DEVICE: CLEARVIEWHD
CLEARVIEW DIAGNOSTICS INC.        510(k) NO: K140139(TRADITIONAL)
ATTN: CHRISTINE  PODILCHUK        PHONE NO : 732 529 5755   
371 HOES LANE SUITE 104           SE DECISION MADE: 28-MAY-14
PISCATAWAY NJ 08854               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: REHASTIM 2, ERIGOPRO (FES)
HASOMED GMBH                      510(k) NO: K132416(TRADITIONAL)
ATTN: MATTHIAS  WEBER             PHONE NO : 49 391623 0112
PAUL-ECKE-STRASSE 1               SE DECISION MADE: 28-MAY-14
MAGDEBURG    GM 39114             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN
HARTALEGA SDN BHD                 510(k) NO: K133956(TRADITIONAL)
ATTN: NURUL AISYAH  KONG          PHONE NO : 603 3280 3888
NO. 7, KAWASAN PERUSAHAAN SURIA   SE DECISION MADE: 28-MAY-14
BESTARI JAYA, SELANGOR    MY 45600510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP
PONTIS ORTHOPAEDICS, LLC          510(k) NO: K140127(SPECIAL)
ATTN: LEONARD  GORDON             PHONE NO : 415 567 8935   
2299 POST STREET, SUITE 103       SE DECISION MADE: 28-MAY-14
SAN FRANCISCO CA 94115            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: LIFEBORNE INFANT RESUSCITATOR
INTERNATIONAL BIOMEDICAL          510(k) NO: K140707(TRADITIONAL)
ATTN: AMY  PIEPER                 PHONE NO : 512 873 0033   
8206 CROSS PARK DR.               SE DECISION MADE: 28-MAY-14
AUSTIN TX 78754                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CLEARVIEW TOTAL
CLINICAL INNOVATIONS, LLC         510(k) NO: K131781(TRADITIONAL)
ATTN: BRIAN  MCROBERTS            PHONE NO : 801 268 8200   
747 WEST 4170 SOUTH               SE DECISION MADE: 28-MAY-14
MURRAY UT 84123                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)
ST. JUDE MEDICAL, INC.            510(k) NO: K133481(TRADITIONAL)
ATTN: MICHAEL  MCSWEENEY          PHONE NO : 408 522 6112   
645 ALMANOR AVENUE                SE DECISION MADE: 28-MAY-14
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: XGEO GU60A
SAMSUNG ELECTRONICS CO., LTD.     510(k) NO: K140332(TRADITIONAL)
ATTN: AEYOUNG  HA                 PHONE NO : 82 31200 1537
129, SAMSUNG-RO YEONGTONG-GU      SE DECISION MADE: 28-MAY-14
SUWON-SI, GYEONGGI-DO    KS 443742510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: XGEO GC80
SAMSUNG ELECTRONICS CO., LTD.     510(k) NO: K140334(TRADITIONAL)
ATTN: CHULSIN  KIM                PHONE NO : 82 31200 7661
129, SAMSUNG-RO YEONGTONG-GU      SE DECISION MADE: 28-MAY-14
SUWON-SI, GYEONGGI-DO    KS 443742510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE
BIOMET MANUFACTURING LLC          510(k) NO: K140509(TRADITIONAL)
ATTN: TRACY  BICKEL JOHNSON, RAC  PHONE NO : 574 372 1761   
56 EAST BELL DR.                  SE DECISION MADE: 28-MAY-14
WARSAW IN 46581                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SENTIO MMG
INNOVATIVE SURGICAL SOLUTIONS, LLC510(k) NO: K131304(TRADITIONAL)
ATTN: AASHISH  SHAH               PHONE NO : 248 595 0420   
21520 BRIDGE STREET               SE DECISION MADE: 29-MAY-14
SOUTHFIELD MI 48033               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PEEK CAGE FOR THE VERTEBRAL SPINE
NEOORTHO PRODUTOS ORTOPEDICOS S/A 510(k) NO: K132852(TRADITIONAL)
ATTN: TARA  CONRAD                PHONE NO : 305 377 0077   
18851 NE 29TH AVE 720             SE DECISION MADE: 29-MAY-14
AVENTURA FL 33180                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: KOALA TOCO
CLINICAL INNOVATIONS, LLC         510(k) NO: K140163(TRADITIONAL)
ATTN: JOANNE  BRONIKOWSKI         PHONE NO : 508 597 6000   
62 FOREST STREET, STE 300         SE DECISION MADE: 29-MAY-14
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: NIGHT SHIFT
ADVANCED BRAIN MONITORING, INC.   510(k) NO: K140190(TRADITIONAL)
ATTN: ADRIENNE  LENZ              PHONE NO : 262 290 0023   
W324 S3649 COUNTY RD E            SE DECISION MADE: 29-MAY-14
DOUSMAN WI 53118                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: S.E.A.L. FRACTURE FUSION TUBE
D.N.E., LLC                       510(k) NO: K140158(TRADITIONAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD                 SE DECISION MADE: 29-MAY-14
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MOVES SLC
THORNHILL RESEARCH INC            510(k) NO: K140049(TRADITIONAL)
ATTN: CLIFF  ANSEL                PHONE NO : 416 597 1325
210 DUNDAS STREET WEST            SE DECISION MADE: 29-MAY-14
TORONTO    CA M5G2E8              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: XGEO GF50
SAMSUNG ELECTRONICS CO., LTD.     510(k) NO: K140326(TRADITIONAL)
ATTN: JEONGPO  HONG               PHONE NO : 82 31200 4202
129, SAMSUNG-RO YEONGTONG-GU      SE DECISION MADE: 29-MAY-14
SUWON-SI, GYEONGGI-DO    KS 443742510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: T1/T2/T3 TURBINE FAMILY
SIRONA DENTAL SYSTEMS GMBH        510(k) NO: K131319(TRADITIONAL)
ATTN: FRITZ  KOLLE                PHONE NO : 496 251163 294
FABRIKSTRASSE 31                  SE DECISION MADE: 30-MAY-14
BENSHEIM    GM D-64625            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: A-TONE IPL SYSTEM
YBK INVESTMENT INC.               510(k) NO: K131712(TRADITIONAL)
ATTN: JOYCE  BANG                 PHONE NO : 909 680 8562   
1915 WHITE STAR DR.               SE DECISION MADE: 30-MAY-14
DIAMOND BAR CA 91765              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ULTRAPRO COMFORT PLUG
ETHICON, INC.                     510(k) NO: K133198(TRADITIONAL)
ATTN: REYNALDO  LIBROJO           PHONE NO : 908 218 3323   
ROUTE 22 WEST P.O. BOX 151        SE DECISION MADE: 30-MAY-14
SOMERVILLE NJ 08876 0151          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE
DEMETECH CORP.                    510(k) NO: K123940(TRADITIONAL)
ATTN: JOHN  O'BRIEN               PHONE NO : 813 645 2855   
445 APOLLO BEACH BLVD             SE DECISION MADE: 30-MAY-14
APOLLO BEACH FL 33572             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SURFLASH SAFETY I.V. CATHETER
KOFU FACTORY OF TERUMO CORP.      510(k) NO: K141138(SPECIAL)
ATTN: PHILLIP  LESTER             PHONE NO : 410 392 7321   
950 ELKTON BLVD                   SE DECISION MADE: 30-MAY-14
ELKTON MD 21921                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OPTOSSOL COMPRESSION DEVICE SYSTEM
GENOSSIS, LLC                     510(k) NO: K140875(TRADITIONAL)
ATTN: BARRY E SANDS               PHONE NO : 978 358 7307   
29 WATER STREET, SUITE 305        SE DECISION MADE: 30-MAY-14
NEWBURYPORT MA 01950              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BODY FAT ANALYZER AND SCALE
CONMO ELECTRONIC COMPANY LIMITED  510(k) NO: K140594(TRADITIONAL)
ATTN: CHARLES  MACK               PHONE NO : 931 625 4938   
12226 WASHINGTON LANE             SE DECISION MADE: 30-MAY-14
PARKER AZ 85344                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
C.R. BARD, INC.                   510(k) NO: K133251(TRADITIONAL)
ATTN: MICHELE  DAVIS              PHONE NO : 770 784 6274   
8195 INDUSTRIAL BLVD.             SE DECISION MADE: 09-MAY-14
COVINGTON GA 30014                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE
DEGANIA SILICONE, LTD.            510(k) NO: K132686(TRADITIONAL)
ATTN: ZOYA  LEE                   PHONE NO : 972 46 755122
DEGANIA BET                       SE DECISION MADE: 12-MAY-14
EMEK HAYARDEN    IS 15130         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SINGLE-SITE PORT
INTUITIVE SURGICAL, INC.          510(k) NO: K133203(TRADITIONAL)
ATTN: EINAV  YEMINI               PHONE NO : 408 523 2656   
1266 KIFER ROAD BLDG. 101         SE DECISION MADE: 09-MAY-14
SUNNYVALE CA 94086 5206           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: WALLFLEX BILIARY RX STENT SYSTEM
BOSTON SCIENTIFIC                 510(k) NO: K140630(TRADITIONAL)
ATTN: THOMAS  HIRTE               PHONE NO : 508 683 4454   
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 23-MAY-14
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA
 
 
                                                 TOTAL 510(k)s THIS PERIOD   241                                     
                                                 TOTAL WITH SUMMARIES        236                                     
                                                 TOTAL WITH STATEMENTS        5