FDA 510(k) Applications Received During July, 2014

FDA 510(k) Number Submission Date Device Name Applicant Contact
K141823 07/07/2014 AAP LOQTEC CLAVICLE PLATES 2.7/3.5 AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K141949 07/18/2014 CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K141782 07/02/2014 HI-TORQUE VERSATURN GUIDE WIRE Abbott Vascular VIVEK THAKKAR
K141912 07/15/2014 AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON ADVANCED ORTHOPAEDIC SOLUTIONS, INC. ANNA HWANG
K141993 07/22/2014 NAKOMA ACP ALLIANCE PARTNERS, LLC KELLEN HILLS
K141865 07/10/2014 DANA ANTHROTRONIX, INC CORINA E LATHAN, PHD, PE
K142035 07/28/2014 GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM ARKRAY FACTORY INC. LONNA M DENDOOVEN
K142078 07/31/2014 VELASII THERAPY LASER SYSTEM ASPEN LASER SYSTEMS, LLC A. BRAUN HENDERSON
K142036 07/28/2014 INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS B. BRAUN MEDICAL, INC. TRACY MADDOCK
K142011 07/24/2014 SOLUTION SET/EXTENSION SET BAXTER HEALTHCARE CORPORATION TIFFANY LIN
K141973 07/21/2014 DIODE LASER HAIR REMOVAL SYSTEM BEIJING ANCHORFREE TECHNOLOGY CO., LTD Diana Hong
K142023 07/25/2014 LUNA INTERBODY SYSTEM BENVENUE MEDICAL, INC. CINDY DOMECUS, R.A.C. (US & EU)
K141924 07/16/2014 HD BLOOD PRESSURE MONITOR BIOCARE ASIA CORPORATION LTD. Ke-Min Jen
K141791 07/02/2014 BIOMET FUSION SYSTEM BIOMET SPINE TED KUHN
K141804 07/03/2014 POLARIS SPINAL SYSTEM - HA COATED BIOMET SPINE LLC, KIMBERLY MCCOY
K141762 07/01/2014 PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM BIOMET, INC. LONNIE WITHAM
K142020 07/25/2014 LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND BIOBAG 50/100/200/300/400 BIOMONDE ROSINA ROBINSON, RN, MED, RAC
K141820 07/07/2014 JAGWIRE HIGH PERFORMANCE GUIDWIRE BOSTON SCIENTIFIC CORP. ALLISON BAILLIE
K141831 07/07/2014 HYDRAVIEW GUIDEWIRE BRIVANT LIMITED KENNETH WALSH
K141985 07/22/2014 TRUE BA V BALLOON VALVULOPLASTY CATHETER C.R. BARD, INC. AARON CONOVALOFF
K141844 07/08/2014 RESCAN 700, CALLISTO EYE CARL ZEISS MEDITEC AG MANDY AMBRECHT
K141859 07/10/2014 CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING CENTERS FOR DISEASE CONTROL AND PREVENTION Yon Yu, Pharm.D.
K142047 07/28/2014 EIDON CENTERVUE SPA ROGER GRAY
K141942 07/17/2014 MIDLINE II TI CENTINEL SPINE, INC. JUSTIN EGGLETON
K142079 07/31/2014 STALIF CTI, STALIF C CENTINEL SPINE, INC. JUSTIN EGGLETON
K142045 07/28/2014 XPERT FLU/RSV XC ASSAY CEPHEID SCOTT A CAMPBELL,PH.D.,MBA
K141829 07/07/2014 GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM CERAGEM MEDISYS INC. Hak-Sung Kim
K141806 07/03/2014 CLEAR GUIDE ONE CLEAR GUIDE MEDICAL JACK KENT
K141909 07/15/2014 COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP COLLAGEN MATRIX, INC. PEGGY HANSEN
K141818 07/07/2014 TURBO-JECT PICC SETS COOK CORPORATED SEAN SPENE
K142012 07/24/2014 FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS CORPAK MEDSYSTEMS STEPHANIE WASIELEWKI
K141858 07/10/2014 CLOSURERFG RADIOFREQUENCY GENERATOR COVIDIEN Laura Moen-Ftacek
K142048 07/28/2014 EMPRINT PROCEDURE PLANNING APPLICATION Covidien LLC HEATHER V NIGRO
K141894 07/14/2014 SHARKCORE FINE NEEDLE BIOPSY SYSTEM COVIDIEN LLC (FORMERLY BEACON ENDOSCOPIC CORP) Saket Bhatt
K141801 07/03/2014 HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM COVIDIEN, LLC JULIE UNDERDAHL
K142000 07/23/2014 ESOFLIP ES CROSPON, LTD. PAUL DRYDEN
K142072 07/23/2014 GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) CUSTOM ORTHOPAEDIC SOLUTIONS, INC. JUSTIN J BAKER,PHD
K141809 07/07/2014 RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM DEFIBTECH, LLC Ed Horton
K142076 07/31/2014 CLAVEGUARD FREEDOM SURGICAL LIGHT DICKSON & DICKSON HEALTHCARE (US), INC RAGUNATH MUNIANDY
K142080 07/31/2014 NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED ECOLAB, INC. JENNIFER WILLNER
K141958 07/18/2014 ERB ENDORECTAL BALLOON EDGE MEDICAL LLC GREGORY MATHISON
K141855 07/09/2014 CLARITY ELEKTA LTD.
K141990 07/22/2014 ENCORE HUMERAL SHOULDER STEM ENCORE MEDICAL, L.P. TEFFANY HUTTO
K141916 07/15/2014 PATHASSIST LED LIGHT FIBER Entellus Medical, Inc. GARRETT P AHLBORG
K142042 07/28/2014 ERCHONIA SHL ERCHONIA CORPORATION Kevin Walls
K142008 07/23/2014 MYLABSEVEN, MYLABALPHA ESAOTE S.P.A. Allison Scott
K142077 07/31/2014 MYLABGAMMA ESAOTE, S.P.A. Allison Scott
K141952 07/18/2014 ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED ETHICON ENDO-SURGERY, INC. LINDA HILL
K141776 07/02/2014 STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES ETHICON, INC. PETER CECCHINI
K141797 07/02/2014 ALTEON 6.5MM BONE SCREWS EXACTECH, INC. THOMAS MCNAMARA
K141821 07/07/2014 ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET EXACTECH, INC. THOMAS MCNAMARA
K141850 07/09/2014 FLOSPINE PEDICLE SCREW SYSTEM FLOSPINE RICH JANSEN
K142003 07/23/2014 FDR D-EVO II FLAT PANEL DETECTOR SYSTEM FUJIFILM MEDICAL SYSTEM U.S.A., INC. KATHERINE Y CHOI
K141765 07/01/2014 FDR D-EVO FLAT PANEL DETECTOR SYSTEM FUJIFILM MEDICAL SYSTEMS U.S.A., INC. KATHERINE Y CHOI
K141768 07/01/2014 LOGIQ V5/LOGIQ V3 GE HEALTHCARE BRYAN BEHN
K142085 07/31/2014 DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T GE MEDICAL SYSTEMS, LLC JENNY WONG
K142044 07/28/2014 CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE Guangzhou Wondfo Biotech Co., Ltd. Joe Shia
K142063 07/30/2014 #8C RENEGADE DENTAL HANDPIECE HANDPIECE CLUB, LLC TINA WU
K141822 07/07/2014 SENSEI X ROBOTIC CATHETER SYSTEM HANSON MEDICAL, INC. TODD MILHOLLAND
K141869 07/11/2014 QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT HEMEDEX INCORPORATED DEAN HONKONEN
K142029 07/25/2014 MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM HOLOGIC, INC. SARAH FAIRFIELD
K142037 07/28/2014 QUANTRA HOLOGIC, INC. CATHERINE WILLIAMS
K141792 07/02/2014 GENESIS TOUCH SYSTEM HONEYWELL HOMMED CLAUDIA JACKSON
K142054 07/29/2014 IMACOR ZURA EVO IMAGING SYSTEM IMACOR INC. JAMES W MONROE
K141872 07/11/2014 SUDOSCAN IMPETO MEDICAL INC Calley Herzog
K141950 07/18/2014 HFD100 ROCKER ARM ACCESSORY IMRIS, INC. KARISSA HOLCOMB
K141967 07/21/2014 PUREFILL OXYGEN COMPRESSOR INOVO, INC. PAUL DRYDEN
K141841 07/08/2014 INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP INTEGRA LIFESCIENCE CORPORTATION NICOLE C HARLAN
K141848 07/09/2014 IOGYN SYSTEM IOGYN, INC. RICH CHRISTENSEN
K142016 07/25/2014 CAPRI K2M, INC. NANCY GIEZEN
K141873 07/11/2014 RANGE/MESA/DENALI SPINAL SYSTEM K2M, INC. NANCY GLEZEN
K141891 07/14/2014 MEDICAL LCD MONITOR KOSTEC CO., LTD Priscilla Chung
K141908 07/15/2014 DUAL SWITCH LASER ENGINEERING, INC. LAURIE DOBBS
K141877 07/11/2014 LEAF PATIENT MONITORING SYSTEM LEAF HEALTHCARE, INC. RONALD S WARREN
K141905 07/15/2014 PRO-LINK WEDGE SYSTEM LIFE SPINE RANDY LEWIS
K141769 07/01/2014 OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER LIGHTLAB IMAGING, INC. JEFFREY ROBERTS
K141989 07/22/2014 MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM MAKO SURGICAL CORPORATION JONATHAN REEVES
K141988 07/22/2014 M.U.S.T PEDICLE SCREW SYSTEM MEDACTA INTERNATIONAL ADAM GROSS
K141951 07/18/2014 DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE MEDTRONIC INC. KEVIN T LAM
K141824 07/07/2014 MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP MEDTRONIC SOFAMOR DANEK, INC. COURTNEY N LONG
K141870 07/11/2014 BREAST VOLUME NAVIGATOR METRITRACK LLC MIRELA WOHLFORD
K142014 07/24/2014 SOFIA DISTAL ACCESS CATHETER MICROVENTION, INC. Naomi Gong
K141885 07/11/2014 CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY MINXRAY, INC. DANIEL KAMM
K141983 07/21/2014 NEUROBLATE SYSTEM MONTERIS MEDICAL CORP CRAIG COOMBS
K141811 07/07/2014 MORTARA MONITORING WAVEFORM VIEWER MORTARA INSTRUMENT, INC. AMY YANG
K142033 07/25/2014 VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP) NANOSPERE,INC. NOAH LERMER
K141771 07/01/2014 PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY NANOSTRING TECHNOLOGIES INC. SYLVA KRIZAN
K142084 07/31/2014 EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX NCONTACT SURGICAL, INC. JANE RICUPERO
K141832 07/07/2014 3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE NEOCOIL, LLC MICHAEL LEIGH
K142060 07/29/2014 TRANSOM ANTERIOR CERVICAL PLATE NEUROSTRUCTURES, INC. MEREDITH MAY
K141994 07/22/2014 BULK FILL FLOWABLE COMPOSITE NOVOCOL, INC. CORA BRACHO-TROCONIS
K141968 07/21/2014 NUVASIVE NVM5 SYSTEM NUVASIVE, INC. JEREMY MARKOVICH
K141896 07/14/2014 COROENT SYSTEM NUVASIVE, INCORPORATED OLGA LEWIS
K142050 07/28/2014 NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEM NUVASIVE, INCORPORATED MICHELLE CHEUNG
K141759 07/01/2014 OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS OAK RIDGE PRODUCTS, LLC CONOR J O'MALLEY
K141787 07/02/2014 SAGITTILT ORFIT INDUSTRIES NV Lee Leichter
K141784 07/02/2014 ORTHO SOLUTIONS ULTOS PLATING SYSTEM ORTHO SOLUTIONS LIMITED AL LIPPINCOTT
K141842 07/08/2014 STARBAND, STARLIGHT ORTHOMERICA PRODUCTS, INC. DAVID C KERR
K141930 07/16/2014 OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML OSSEON LLC KEITH BURGER
K141794 07/02/2014 ENDO-MARYLAND DISSECTOR OVESCO ENDOSCOPY AG TANJA R LINZER
K141979 07/21/2014 ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V. JEANETTE BECKER
K142027 07/25/2014 888 WNLE POWERED WHEELCHAIR PIHSIANG MACHINERY MFG. CO., LTD. DAVID LIN
K141998 07/23/2014 SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS PINGHU SAMA MEDICAL PACKING CO., LTD. CHARLES SHEN
K141816 07/07/2014 HEMOPORE Polyganics BV BETTY IJMKER
K141839 07/08/2014 PREMIER ETCH PREMIER DENTAL PRODUCTS CO. VINCENT D'ALESSANDRO
K141788 07/02/2014 OBSIDIAN MILLING BLOCKS PRISMATIK DENTALCRAFT, INC. ARMIN ZEHTABCHI
K141887 07/14/2014 OBSIDIAN PRESS (ALL CERAMIC AND POM) PRISMATIK DENTALCRAFT, INC. ARMIN ZEHTABCHI
K141956 07/18/2014 FIBERGRAFT BG MORSELS PROSIDYAN, INC JANICE M HOGAN
K141834 07/07/2014 SAPPHIRE ADMINISTRATION SET Q CORE MEDICAL LTD Rhona Shanker
K142002 07/23/2014 BREAST SPEEDER CX, GRID HOLDER CX QUALITY ELECTRODYNAMICS, LLC. Kathleen Aras
K141931 07/16/2014 LYRA ADENOVIRUS ASSAY QUIDEL CORPORATION Ronald H Lollar
K141927 07/16/2014 LYRA PARAINFLUENZA VIRUS ASSAY QUIDEL CORPORATION Ronald H Lollar
K141881 07/11/2014 RAPIDRESULTS RAMSOFT, INC. LELY LAM-HONG
K141860 07/10/2014 RAYSTATION RAYSEARCH LABORATORIES AB DAVID HEDFORS
K141838 07/08/2014 SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL) REGULATORY TECHNOLOGY SERVICES LLC MARK JOB
K142017 07/25/2014 X-PORTE ULTRASOUND SYSTEM REGULATORY TECHNOLOGY SERVICES LLC MARK JOB
K141954 07/18/2014 XCEL 455 SLIT LAMP REICHERT, INC. THOMAS M HECKMANN
K141813 07/07/2014 RHYTHMSTAR SYSTEM RHYTHMEDIX, LLC M.W.(ANDY) ANDERSON
K142021 07/25/2014 Elecsys Estradiol III CalSet Roche Diagnostics KELLI TURNER
K141928 07/16/2014 COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR Roche Diagnostics Operations (RDO) NOEL K MENCIAS
K142070 07/30/2014 FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS RTI SURGICAL, INC. KRISTINA HALL
K141895 07/14/2014 MOBILEDIAGNOST WDR SEDECAL SA JENNIFER CARTLEDGE
K141772 07/01/2014 IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL Siemens Healthcare Diagnostics Inc. Asha Gartland
K141846 07/09/2014 ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. SHELLY PEARCE
K141971 07/21/2014 BIOGRAPH TRUE PET/CT FAMILY SOFTWARE SIEMENS MEDICAL SOLUTIONS USA, INC. ALAINE MEDIO
K141977 07/21/2014 MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL SIEMENS MEDICAL SOLUTIONS USA, INC. NADIA SOOKDEO
K142006 07/23/2014 SYMBIA 6.0 SIEMENS MEDICAL SOLUTIONS USA, INC. CYNTHIA BUSCH
K141835 07/07/2014 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS SPINE ART FRANCK PENNESI
K142026 07/25/2014 SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE SPINEFRONTIER, INC. MEREDITH MAY
K141871 07/11/2014 Straumann Bone Level NC Angled Screw Retained Abutments STRAUMANN USA, LLC CHRISTOPHER KLACZYK
K141941 07/17/2014 SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP 3D 3.0-ENABLE, SPINEMAP 3D 3.0-SALES D STRYKER CORPORATE LILIAN ECKERT
K142066 07/30/2014 AERO-LL LUMBAR CAGE SYSTEM STRYKER CORPORATION TIFFANI ROGERS
K141935 07/17/2014 STRYKER S2 DRILL STRYKER CORPORATION VISHAL KANANI
K141992 07/22/2014 VARIAX 2 SYSTEM Stryker Trauma AG ESTELA CELI
K141800 07/03/2014 PERFRACTION SUN NUCLEAR CORPORATION JEFF KAPATOES
K141778 07/02/2014 QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN SURGICAL SPECIALTIES CORPORATION KIRSTEN STOWELL FRANCO
K141796 07/03/2014 DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM SYNTHES (USA) PRODUCTS LLC KARA ELKIN
K141897 07/14/2014 SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM SYNTHES USA PRODUCTS, LLC MITCH OHIWA
K141939 07/17/2014 TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT; WITH STYLET Teleflex Medical, Inc. JAMES A COCHIE
K141940 07/17/2014 CONCHASMART COLUMN TELEFLEX, INC. Amanda Webb
K141953 07/18/2014 ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL TITAN SPINE, LLC CHRISTINE SCIFERT
K141972 07/21/2014 KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY TOTAL JOINT ORTHOPEDICS, INC. CHRIS WEABER
K141917 07/15/2014 UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR UNICON OPTICAL CO., LTD. MICHAEL LEE
K142062 07/30/2014 SPIRAL FLOW PERIPHERAL VASCULAR GRAFT VASCULAR FLOW TECHNOLOGIES LTD EDWIN LINDSAY
K142065 07/30/2014 TURNPIKE CATHETER VASCULAR SOLUTIONS, INC. ELLIE GILLESPIE
K141937 07/17/2014 TRIDENT FUSION IMPLANT VILEX IN TENNESSEE, INC. ABRAHAM LAVI
K141904 07/14/2014 VIORA V-TOUCH VIORA LTD. YORAM LEVY
K142086 07/31/2014 NIO -INTRAOSSEOUS DEVICE WAISMED LTD. JONATHAN S KAHAN
K142082 07/31/2014 ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT ZIMMER DENTAL INC. CHRISTINA BOYDSON
K142053 07/29/2014 UNIVERSAL CLAMP SPINAL FIXATION SYSTEM ZIMMER SPINE, INC. HOLLY SEPPANEN
K142166 07/30/2014 TOTAL SHIELD SURGICAL;TOGA(REGULAR, LARGE,X-LARGE);HOOD; HELMET ADVANCED HELMET W/LED LIGHTING, TOTAL SHIELD ACCESSORIES ZIMMER, INC. ANGELA ESTRADA
K141840 07/08/2014 TRABECULAR METAL TIBIAL CONE BROACH, TRABECULAR METAL COUPLED TIBIAL CONE BROACH ZIMMER, INC. DIANA TAYLOR
K141774 07/02/2014 ZOLL X SERIES ZOLL MEDICAL CORPORATION TAMMAY SHUKLA


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