| 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 |
