FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K130762 |
04/29/2013 |
AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET |
AALTO SCIENTIFIC LTD. |
DESSI LYAKOV |
K130764 |
04/26/2013 |
AUDIT MICROCV VITAMIN D LINEARITY SET |
AALTO SCIENTIFIC LTD. |
DESSI LYAKOV |
K130590 |
04/22/2013 |
AAP CANNULATED SCREW 2.0 |
AAP IMPLANTATE AG |
CHRISTIAN ZIETSCH |
K123888 |
04/15/2013 |
Z CARTRIDGE IOL DELIVERY SYSTEM |
AAREN SCIENTIFIC, INC |
ROBERT K SHEEHAN |
K123089 |
04/05/2013 |
FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001 |
ABBOTT LABORATORIES |
DAVID G LAMBERT |
K122076 |
04/15/2013 |
PERSONAL HEALTH CENTER (PHC) |
ADFLOW HEALTH NETWORKS INC |
Glen Feye |
K123936 |
04/24/2013 |
SURGISEAL TOPICAL SKIN ADHESIVE |
Adhezion Biomedical, LLC |
Caridad Smith |
K130007 |
04/17/2013 |
SLEEP PROFILER |
ADVANCED BRAIN MONITORING, INC. |
ADRIENNE LENZ |
K123909 |
04/15/2013 |
AESCULAP CESPACE XP |
AESCULAP IMPLANT SYSTEM, INC. |
LISA M BOYLE |
K130291 |
04/11/2013 |
S4 SPINAL SYSTEM |
AESCULAP IMPLANT SYSTEM, INC. |
LISA M BOYLE |
K130535 |
04/17/2013 |
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION |
AGAMATRIX INC |
WILLIAM H MCGRAIL |
K123018 |
04/23/2013 |
ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
HYMAN KATZ PH.D. |
K123128 |
04/25/2013 |
SERI SURGICAL SCAFFOLD |
ALLERGAN |
CONNIE GARRISON |
K123796 |
04/05/2013 |
NEURO OMEGA SYSTEM |
ALPHA OMEGA ENGINEERING LTD. |
ILAN SHARON |
K130548 |
04/18/2013 |
EPICAGE INTERBODY FUSION DEVICE |
ALPHATEC SPINE, INC. |
NADINE SMITH |
K123943 |
04/02/2013 |
AMECATH DUAL LUMEN HEMODIALYSIS CATHETER |
AMECO MEDICAL INDUSTRIES |
Ray Kelly |
K123935 |
04/12/2013 |
IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM |
ANDON MEDICAL CO., LTD. |
YI LIU |
K130152 |
04/18/2013 |
HYDRASOLVE LIPOPLASTY SYSTEM |
ANDREW TECHNOLOGIES, LLC |
HERBERT CRANE |
K124027 |
04/05/2013 |
MONSTER SCREW SYSTEM |
APOGEE ORTHOSOLUTIONS |
KAREN E WARDEN, PHD |
K123716 |
04/19/2013 |
AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT |
APPLIED MEDICAL TECHNOLOGY, INC. |
GRANT W PHILLIPS |
K130677 |
04/12/2013 |
APTUS HELI-FX AORTIC SECUREMENT SYSTEM |
APTUS ENDOSYSTEMS, INC. |
BURT GOODSON |
K121659 |
04/18/2013 |
BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS) |
ARCOS, INC. |
CHRIS MEADOR |
K130876 |
04/26/2013 |
CG+ ARROW PICC POWERED BY ARROW VPS STYLET |
ARROW INTERNATIONAL, INC. |
ELIZABETH DUNCAN |
K123241 |
04/05/2013 |
ARTHREX FRACTURE PLATES |
ARTHREX, INC. |
COURTNEY SMITH |
K123353 |
04/05/2013 |
CIQ CONTROLLER, CIQ WANDS |
ARTHROCARE CORPORATION |
MITCHELL DHORITY |
K130957 |
04/30/2013 |
WVSM (WIRLESS VITAL SIGNS MONITOR) |
ATHENA GTX |
SEAN MAHONEY |
K130521 |
04/05/2013 |
ISOLATOR LINEAR PEN |
ATRICURE, INC. |
REBECCA WALTERS |
K130576 |
04/02/2013 |
CELSITE IMPLANTABLE ACCESS PORT SYSTEMS |
B. BRAUN INTERVENTIONAL SYSTEMS INC. |
AMBER KINGSTON |
K122167 |
04/22/2013 |
NEXXIS OR |
BARCO NV |
LIEVEN DE WANDEL |
K123921 |
04/26/2013 |
BODYTRONIC 200 |
BAUERFEIND AG |
INES EXNER |
K123483 |
04/21/2013 |
DIODE LASER |
BEIJING SYNTECH LASER CO., LTD. |
Diana Hong |
K122112 |
04/09/2013 |
2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM |
BIO COMPRESSION SYSTEMS, INC. |
Maureen Garner |
K130761 |
04/12/2013 |
LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK |
Bio-Rad Laboratories |
SUZANNE PARSONS |
K130860 |
04/25/2013 |
VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE |
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS |
EBONY MCKINNIES |
K122307 |
04/05/2013 |
DIAVUE PRUDENTIAL BLOOD GLUCOSE MONITORING SYSTEM |
BIOCARE CORPORATION |
SHUCHI CHANG |
K130465 |
04/11/2013 |
EPIC 10S |
BIOLASE TECHNOLOGY, INC. |
COLLEEN BOSWELL |
K130063 |
04/19/2013 |
ARCOS TROCHANTER BUTTON |
BIOMET, INC. |
BECKY EARL |
K123961 |
04/05/2013 |
SENTREX BIOSPONGE MPD |
BIONOVA MEDICAL, INC |
ALEX GREENE |
K122703 |
04/25/2013 |
RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR |
BIOPHOR DIAGNOSTICS, INC. |
Nathaniel G Butlin |
K130161 |
04/23/2013 |
PASSEO-35 |
BIOTRONIK, INC. |
Jon Brumbaugh |
K123820 |
04/02/2013 |
BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS |
BOSSONG HOSIERY MILLS, INC |
ROGER RAND |
K123621 |
04/15/2013 |
OPTICROSS 40 MHZ CORONARY IMAGING CATHETER |
BOSTON SCIENTIFIC CORP. |
ERIC ELLIOTT |
K130121 |
04/11/2013 |
SHORT PORT BLUNT TIP TROCAR |
Boston Scientific Corporation |
MARK DINGER |
K122225 |
04/26/2013 |
STERILE RADIOLUCENT SKULL PINS |
BRAINLAB AG |
ALEXANDER SCHWIERSCH |
K122966 |
04/08/2013 |
XP200 |
BTL INDUSTRIES LTD |
RICHARD VINCINS |
K123028 |
04/25/2013 |
VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH |
CALDERA MEDICAL, INC. |
VICKI GAIL |
K130678 |
04/12/2013 |
BIOMARC GOLD FIDUCIAL MARKER |
CARBON MEDICAL TECHNOLOGIES, INC. |
ANDREW J ADAMS |
K123527 |
04/25/2013 |
AIRLIFE |
CAREFUSION |
ERIKA FERNANDEZ |
K122418 |
04/12/2013 |
IOLMASTER 500 |
CARL ZEISS MEDITEC AG |
JUDITH A BRIMACOMBE |
K123700 |
04/11/2013 |
FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER |
CAS MEDICAL SYSTEMS, INC. |
RON JEFFREY |
K122888 |
04/30/2013 |
CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM |
CDR SYSTEMS, INC. |
CARL DENIS |
K123122 |
04/05/2013 |
GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) |
CLEVELAND CLINIC |
STEPHEN J PEOPLES, VMD, MS |
K123386 |
04/26/2013 |
PERIOTYPE X-PERT |
CLINICAL HOUSE EUROPE GMBH |
JUDI WEISSINGER |
K130194 |
04/03/2013 |
ACCULIF XL CAGE |
COALIGN INNOVATIONS, INC. |
JUSTIN EGGLETON |
K120250 |
04/21/2013 |
FIBRILLAR COLLAGEN WOUND DRESSING |
COLLAFIRM LLC |
SURENDRA BATRA |
K130482 |
04/29/2013 |
COMBAT READY CLAMP |
COMBAT MEDICAL SYSTEMS, LLC |
Calley Herzog |
K130006 |
04/05/2013 |
BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS |
COOK BIOTECH INCORPORATED |
NICK X WANG |
K122716 |
04/17/2013 |
PLASMATRODE SALINE SAFE TUR ELECTRODE |
COOK IRELAND LTD |
NORA O'CONNOR |
K130673 |
04/15/2013 |
LOSPA TOTAL KNEE REPLACEMENT SYSTEM |
CORENTEC CO., LTD |
J.S. DANIEL |
K123083 |
04/17/2013 |
COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT |
COVIDIEN |
STACEY A STRAND |
K130744 |
04/05/2013 |
LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER |
COVIDIEN |
DIANE REED |
K130782 |
04/05/2013 |
ACCUMESH DEPLOYMENT SYSTEM |
Covidien LLC |
JOSE MARQUEZ |
K130725 |
04/17/2013 |
MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR. |
COVIDIEN LP, FORMERLY REGISTERED AS KENDALL |
DOLLY MISTRY |
K130717 |
04/18/2013 |
ENDO GIA RELOAD |
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
KATHERINE ROBERTSON |
K120599 |
04/30/2013 |
DEPUY M-SPEC 36MM FEMORAL HEADS |
DEPUY ORTHOPAEDICS |
CORRENE RAMY |
K130571 |
04/09/2013 |
DEVON CIRONA 6100 DVT |
DEVON MEDICAL INC. |
RUTH WU |
K124009 |
04/17/2013 |
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C |
DIAMOND DIAGNOSTICS, INC. |
KATHY CRUZ |
K130321 |
04/09/2013 |
LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS |
DIASORIN |
CAROL DEPOUW |
K121951 |
04/04/2013 |
LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3 |
DIASORIN, INC. |
KELLY R SAUER |
K130469 |
04/05/2013 |
LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3 |
DIASORIN, INC. |
KELLY SAUER |
K130711 |
04/11/2013 |
INFINITY CENTRALSTATION WITH INFINITY M300 |
Draeger Medical Systems, Inc. |
TOM OSTROWSKI |
K123806 |
04/05/2013 |
FIBROSCAN |
ECHOSENS |
ZVI LADIN, PH.D. |
K123263 |
04/04/2013 |
HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS |
ECKERT & ZIEGLER BEBIG GMBH |
HUB VAN DE BERGH |
K122381 |
04/22/2013 |
NEXFIN MODEL 2 |
EDWARDS LIFESCIENCES, LLC. |
MARGUERITE THOMLINSON |
K123808 |
04/04/2013 |
AGILITY |
ELEKTA LTD. |
Patrick Hull |
K130765 |
04/04/2013 |
ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II |
ELITECHGROUP |
DEBRA K HUTSON |
K122485 |
04/23/2013 |
ENCIRCLE COMPRESSION THERAPY STOCKING |
ENCIRCLE MEDICAL DEVICES LTD. |
SIGI CARON |
K122239 |
04/11/2013 |
FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH TINBN COATING 3DKNEE SYSTEM WITH TINBN COATING |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
K130741 |
04/23/2013 |
ERCHONIA PL5000 |
ERCHONIA MEDICAL INC |
Kevin Walls |
K123853 |
04/15/2013 |
VIVASIGHT-DL SYSTEM |
ETVIEW LTD. |
YORAM LEVY |
K112996 |
04/09/2013 |
EUROIMMUN ANTI-ENA POOL ELISA (IGG) |
EUROIMMUN US |
KATHRYN KOHL |
K113439 |
04/12/2013 |
EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG) |
EUROIMMUN US |
KATHRYN KOHL |
K122194 |
04/04/2013 |
LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
ROBERT TU |
K130120 |
04/11/2013 |
EXTREMITY MEDICAL IP FUSION SYSTEM |
EXTREMITY MEDICAL, LLC |
BRIAN SMEKAL |
K130453 |
04/02/2013 |
EXCELSIOR |
EYEKOR, LLC. |
MAUREEN O'CONNELL |
K123701 |
04/05/2013 |
HEARLAB ACA |
FRYE ELECTRONICS, INC. |
KRISTINA FRYE |
K130383 |
04/09/2013 |
SYNAPSE 3D CARDIAC TOOLS |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
JYH-SHYAN LIN |
K123430 |
04/12/2013 |
MICROSLIDER TEARAWAY INTRODUCER SET |
GALT MEDICAL CORP. |
DAVID DERRICK |
K130069 |
04/05/2013 |
INNOVA EPVISION 2.0, INNOVA EPVISION 2.0 |
GE HEALTHCARE |
NING WEN |
K130884 |
04/12/2013 |
XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION |
GE MEDICAL SYSTEMS F.I. HAIFA |
ELI WERNER |
K123996 |
04/09/2013 |
RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
MARY CARTER |
K130470 |
04/02/2013 |
BD MAX CDIFF ASSAY, BD MAX INSTRUMENT |
GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) |
PATRICIA DIONNE |
K130886 |
04/25/2013 |
GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION |
GLOOKO, INC. |
SHILPA MYDUR |
K123915 |
04/24/2013 |
DE48-PLUS |
GRASS TECHNOLOGIES, AN ASTRO-MED, INC. PRODUCT GRO |
PHILLIP SOARES |
K130665 |
04/09/2013 |
WONDOFO MULTI-DRUG URINE TEST CUP / PANEL |
Guangzhou Wondfo Biotech Co., Ltd. |
Joe Shia |
K123429 |
04/05/2013 |
OLYMPUS ENERGY POWER SYSTEM (EPS) |
GYRUS ACMI, INC. |
DOLAN MILLS |
K121770 |
04/17/2013 |
HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER |
HEADSTAR MEDICAL PRODUCTS CO., LTD |
GLORIA CHEN |
K123703 |
04/10/2013 |
HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE) |
HEALGEN SCIENTIFIC, LLC |
BRYAN FANG |
K123410 |
04/05/2013 |
HEALTHY SLEEP APPLIANCE |
HEALTHY SLEEP DENTAL LABORATORY |
PAUL DRYDEN |
K124032 |
04/25/2013 |
METANEB |
HILL-ROM SERVICES PTE LTD |
PAUL DRYDEN |
K130308 |
04/05/2013 |
NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM |
HITACHI ALOKA MEDICAL, LTD. |
ANGELA VANARSDALE |
K122537 |
04/12/2013 |
PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0 |
HITACHI ALOKA MEDICAL,LTD. (HITACHI ALOKA MEDICAL |
RICHARD J CEHOVSKY |
K123804 |
04/17/2013 |
INSTAFLO BOWEL CATHETER SYSTEM KIT |
HOLLISTER, INC. |
CHRIS STUKEL |
K130361 |
04/02/2013 |
THERMOFINDER; THERMOCARE |
HUBDIC CO., LTD |
MATT HANSEN |
K122510 |
04/26/2013 |
ICRCO 3600M |
ICRCO INC. |
GREG WACHTLER |
K130306 |
04/11/2013 |
INCITE ANCHORED CERVICAL INTERBODY DEVICE |
INCITE INNOVATION LLC |
JOHN KIRWAN |
K122453 |
04/05/2013 |
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, GREY |
INDUSTRIAL CLOTHINGS, LTD. |
S.N. HARI |
K122464 |
04/12/2013 |
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, ORANGE |
INDUSTRIAL CLOTHINGS, LTD. |
S.N. HARI |
K123860 |
04/02/2013 |
INMODE SR IPL DEVICE |
INMODE MD LTD. |
AHAVA STEIN |
K123972 |
04/01/2013 |
WALKAIDE SYSTEM |
INNOVATIVE NEUROTRONICS INC. |
GLEN NEALLY |
K123593 |
04/17/2013 |
QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS, |
INOVA DIAGNOSTICS, INC. |
GABRIELLA LAKOS |
K130389 |
04/23/2013 |
MAYFIELD INFINITY XR2 SKULL CLAMP |
INTEGRA LIFESCIENCES CORPORATION |
JANET KAY |
K122549 |
04/26/2013 |
DENTO TEMP |
ITENA CLINICAL |
LOUIS-PAUL MARIN |
K121804 |
04/19/2013 |
PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM |
ITENA CLINICAL |
LOUIS PAUL MARIN |
K123507 |
04/04/2013 |
KCI NPWT GAUZE DRESSING |
KCI USA, INC. |
ANONA GOEBEL |
K122049 |
04/05/2013 |
NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM |
KINAMED, INC. |
HEATHER NEELY |
K130371 |
04/09/2013 |
CLEARFIL MAJESTY ES FLOW |
KURARAY NORITAKE DENTAL INC. |
MICHIO TAKIGAWA |
K122069 |
04/11/2013 |
STORM MINI SCREW |
LANCER ORTHODONTICS, INC. |
LARRY WALKER |
K130056 |
04/11/2013 |
PATIENT MONITOR |
LD TECHNOLOGY LLC |
ALBERT MAAREK |
K130202 |
04/29/2013 |
IRIS ANTERIOR CERVICAL PLATE |
LIFE SPINE, INC |
RANDY LEWIS |
K130817 |
04/17/2013 |
LTN - LAPAROSCOPIC SURGICAL MESH |
LIFECELL CORP. |
JOHN BLEWITT |
K130518 |
04/30/2013 |
MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER |
LUTHER NEEDLESAFE PRODUCTS, INC. |
Rebecca K Pine |
K121478 |
04/05/2013 |
NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP |
MAPA GMBH |
MARK WOZNIAK |
K120984 |
04/26/2013 |
MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR |
MASIMO CORPORATION |
PATRICIA MILBANK |
K123676 |
04/18/2013 |
CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES |
MAUNA KEA TECHNOLOGIES |
MICHAEL DANIEL |
K130441 |
04/19/2013 |
FALLER STYLET |
MEDIONICS INTERNATIONAL, INC. |
MAHESH AGARWAL |
K130637 |
04/10/2013 |
JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM |
MEDRAD, INC. |
BRIT BAIRD |
K123733 |
04/01/2013 |
CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM |
MEDTRONIC INC. |
KARI CHRISTIANSON |
K123153 |
04/09/2013 |
ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT |
MEDTRONIC IRELAND |
DEIRDRE MCMAHON |
K123978 |
04/09/2013 |
CAPSTONE L SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA |
LAUREN KAMER |
K130646 |
04/10/2013 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
BRAD SHEALS |
K130335 |
04/19/2013 |
MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIX |
MEDTRONIC SOFAMOR DANEK USA, INC. |
RYAN MASSEY |
K123906 |
04/01/2013 |
VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CLAIRE EVANS |
K123990 |
04/26/2013 |
SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING |
MEDTRONIC VASCULAR |
KELLEY LAMKE |
K130813 |
04/11/2013 |
MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS |
MENTOR CORP. |
MARTIN SPRUNCK |
K130400 |
04/05/2013 |
MERETEC CS, CORTICAL SCREWS |
MERETE MEDICAL GMBH |
EMMANUEL ANAPLIOTIS |
K130588 |
04/05/2013 |
MERIT HYDROPHILIC GUIDE WIRE |
MERIT MEDICAL SYSTEMS, INC. |
MARTHA FOLAN |
K130100 |
04/18/2013 |
COMINED STANDARD SOLUTION |
MESA LABORATORIES, INC. |
JAMIE LOUIE |
K123271 |
04/26/2013 |
ABBOTT PHENOBARBITAL ASSAY |
MICROGENICS CORP. |
KAREN LEE |
K130269 |
04/19/2013 |
ECAT SCINTRON PET |
MIE GMBH |
THOMAS KUEHL |
K123892 |
04/05/2013 |
MEPILEX TRANSFER AG |
MOLNLYCKE HEALTH CARE |
ANGELA L BUNN, RAC |
K123945 |
04/17/2013 |
STRIVE DUAL ZONE PEAK FLOW METER |
MONAGHAN MEDICAL CORP. |
CARI J REIL |
K120561 |
04/01/2013 |
NEUROBLATE SYSTEM |
MONTERIS MEDICAL, INC. |
JEFF WILSON |
K123445 |
04/01/2013 |
NMI COAXIAL MICROINTRODUCER SET |
NAVILYST MEDICAL, INC. |
WANDA CARPINELLA |
K122767 |
04/30/2013 |
NMI PORT |
NAVILYST MEDICAL, INC. |
Lorraine M Hanley |
K130772 |
04/18/2013 |
MD211C2 21.3 DIAGNOSTIC IMAGING LCD MONITOR |
NEC DISPLAY SOLUTIONS, LTD. |
ANGUS HSU |
K130770 |
04/18/2013 |
MD211C3 21.3 DIAGNOSTIC IMAGING LCD MONITOR |
NEC DISPLAY SOLUTIONS, LTD. |
ANGUS HSU |
K123280 |
04/18/2013 |
NEOCLOSE HASSON, NEOCLOSE UNIVERSAL |
NEOSURGICAL LTD |
ORLA BRENNAN |
K130233 |
04/30/2013 |
NEUROSTAR TMS THERAPY SYSTEM |
NEURONETICS |
JUDY P WAYS, PH.D. |
K130114 |
04/16/2013 |
PAINMASTER MCT PATCH |
NEWMARK, INC. |
CHERITA JAMES |
K120800 |
04/25/2013 |
NVISION VLE IMAGING SYSTEM |
NINEPOINT MEDICAL, INC. |
CINDY DOMECUS, RAC (US & EU) |
K120989 |
04/24/2013 |
TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM |
NIPRO DIAGNOSTICS, INC. |
KAREN DEVINCENT |
K122688 |
04/04/2013 |
NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR |
NOVA BIOMEDICAL CORPORATION |
PAUL W MACDONALD |
K123339 |
04/11/2013 |
TK1 TOTAL KNEE SYSTEM |
NOVOSOURCE INC |
JAMES PINKSTON |
K130023 |
04/03/2013 |
K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR |
NP MEDICAL, INC. |
ROBERT J BARD, JD, RAC, CQE |
K123045 |
04/16/2013 |
BRIGADE STANDALONE SYSTEM |
NUVASIVE, INC. |
Cynthia Adams |
K123307 |
04/23/2013 |
NUVASIVE NVM5 SYSTEM |
NUVASIVE, INC. |
Sheila Bruschi |
K122051 |
04/23/2013 |
NXSTAGE SYSTEM ONE |
NXSTAGE MEDICAL, INC. |
MARY LUO STROUMBOS |
K122198 |
04/05/2013 |
6.00MM X 6.00MM MACRO EXTERNAL IMPLANT SYSTEM |
OCO BIOMEDICAL |
JACK BLOOM |
K123421 |
04/29/2013 |
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM |
OLYMPUS MEDICAL SYSTEMS CORP. |
DAPHNEY GERMAIN-KOLAWOLE |
K122505 |
04/11/2013 |
SINGLE USE PRELOADED SPHINCTEROTOME V |
OLYMPUS MEDICAL SYSTEMS CORP. |
SHERI MUSGNUNG |
K123601 |
04/29/2013 |
SINGLE USE REPOSITIONABLE CLIP |
OLYMPUS MEDICAL SYSTEMS CORP. |
SHERI L MUSGNUNG |
K130489 |
04/19/2013 |
ELECTRODE, FLEXIBLE SUCTION COAGULATOR |
OPTIM, LLC. |
JEFF BARRETT, CEO |
K130643 |
04/23/2013 |
ACCELEDENT AURA |
ORTHOACCEL TECHNOLOGIES, INC |
ZAFFER SYED |
K123243 |
04/05/2013 |
HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY |
ORTHOCON, INC. |
Howard Schrayer |
K123755 |
04/26/2013 |
MULTI ANGLED ABUTMENT |
OSSTEM IMPLANT CO., LTD |
PATRICK LIM |
K123916 |
04/09/2013 |
PSA SERIES |
OSYPKA MEDICAL, INC. |
MARKUS OSYPKA |
K130201 |
04/26/2013 |
NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM |
OTOTRONIX, LLC |
BERNARD HORWATH |
K113781 |
04/26/2013 |
PANTHEON SPINAL IBFD SYSTEM |
PANTHEON SPINAL |
SCOTT SPANN |
K123470 |
04/29/2013 |
PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE |
PAS SYSTEMS INTERNATIONAL, INC. |
JAREL R KELSEY |
K130718 |
04/16/2013 |
PEERSCOPE SYSTEM |
PEERMEDICAL LTD. |
TAMAR FUERST |
K123973 |
04/23/2013 |
AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES |
Pegavision Corporation |
TONY HSU |
K122470 |
04/10/2013 |
PENTAX EPK-I5010 VIDEO PROCESSOR |
PENTAX MEDICAL |
KRISHNA GOVINDARAJAN |
K122905 |
04/30/2013 |
PEREGRINE 23GA CURVED LASER PROBE |
PEREGRINE SURGICAL, LTD. |
RYAN O'LEARY |
K123290 |
04/17/2013 |
M300 & M400 |
PERMOBIL AB |
JAN ASTROM |
K123900 |
04/18/2013 |
SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 |
PHILIPS MEDICAL SYSTEMS |
MARY KRUITWAGEN |
K122223 |
04/12/2013 |
NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO |
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
MARKUS STACHA |
K123597 |
04/17/2013 |
TRUECPR COACHING DEVICE |
PHYSIO-CONTROL, INC. |
TERESA DAVIDSON |
K130286 |
04/01/2013 |
STREAMLINE MIS SPINAL FIXATION SYSTEM |
PIONEER SURGICAL TECHNOLOGY, INC |
EMILY M DOWNS |
K122200 |
04/18/2013 |
A3F FRATIONAL |
POLLOGEN LTD |
YORAM LEVY |
K123829 |
04/03/2013 |
PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK |
PORTABLE THERAPEUTIX, LLC |
Sharyn Orton |
K123573 |
04/15/2013 |
YOULASER CO2 LASER |
QUANTA SYSTEM, S.P.A. |
Maurizio Bianchi |
K130237 |
04/05/2013 |
PONTIC PAINT |
RELIANCE ORTHODONTIC PRODUCTS, INC. |
PAULA WENDLAND |
K122461 |
04/18/2013 |
RHYTHMIA MAPPING CATHETER |
RHYTHMIA MEDICAL, INC |
LEON AMARIGLIO |
K130423 |
04/03/2013 |
THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
RON HASELHORST |
K130803 |
04/12/2013 |
UGEO H70C DIAGNOSTIC ULTRASOUND SYSTEM |
SAMSUNG MEDISON CO., LTD |
KYEONG-MI PARK |
K130883 |
04/18/2013 |
SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T |
SEDECAL SA |
LUISA GOMEZ DE AGUERO |
K122908 |
04/26/2013 |
PRG BARRIER COAT |
SHOFU DENTAL CORPORATION |
DAVID P MORAIS |
K123850 |
04/01/2013 |
IFUSE IMPLANT SYSTEM |
SI-BONE, INC. |
CINDY DOMECUS |
K130698 |
04/05/2013 |
DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL) |
SIEMENS HEALTHCARE DIAGNOSTICS |
ANNA MARIE ENNIS |
K122539 |
04/19/2013 |
MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM |
SIEMENS HEALTHCARE DIAGNOSTICS |
Steven Goldberg |
K121576 |
04/04/2013 |
IMMULITE 2000 ANTI-CCP IGG ASSAY |
Siemens Healthcare Diagnostics Inc. |
SUSAN BROCCHI |
K123541 |
04/02/2013 |
SYNGO.CT NEURO PERFUSION |
SIEMENS MEDICAL SYSTEMS, INC. |
KIMBERLY MANGUM |
K122823 |
04/16/2013 |
SIGN PEDIATRIC FIN NAIL |
SIGN FRACTURE CARE INTERNATIONAL |
DOUGLAS DONNELLY |
K130659 |
04/03/2013 |
SPEQRT ULTRASOUND SYSTEM |
SIGNOSTICS PTY LTD |
VARDA SWERY |
K121281 |
04/05/2013 |
SIMPLI SIMPLER IMPLANT SYSTEM |
SIMPLER IMPLANT SOLUTIONS |
HAROLD BERGMAN |
K130402 |
04/01/2013 |
SPIDER SYSTEM KOLIBRI CEMENT NEEDLE |
SINTEA PLUSTEK, LLC |
RICH JANSEN |
K123664 |
04/08/2013 |
INCORIS ZI |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
K123393 |
04/11/2013 |
HEALICOIL SUTURE ANCHOR WITH REGENESORB |
SMITH & NEPHEW, INC. |
SUE DAHLQUIST |
K130119 |
04/12/2013 |
PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM |
SONOSCAPE COMPANY LIMITED |
TOKI WU |
K123962 |
04/08/2013 |
OTOMAG BONE CONDUCTION HEARING SYSTEM |
SOPHONO, INC |
KRISTA B TRAYNOR |
K122146 |
04/22/2013 |
XHIBIT CENTRAL STATION, MODEL 96102 |
SPACELABS HEALTHCARE |
THOMAS KROENKE |
K124049 |
04/18/2013 |
DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM |
Spectral MD, Inc |
DIANE RUTHERFORD |
K123941 |
04/30/2013 |
KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET |
SPENCER FILLMORE |
CHRISTINA BERNSTEIN |
K130445 |
04/25/2013 |
VAULT ALIF SYSTEM |
SPINAL USA |
J.D. WEBB |
K123461 |
04/11/2013 |
STAXX(R) IB SYSTEM |
SPINE WAVE, INC. |
ROAIDA RIZKALLAH |
K123539 |
04/22/2013 |
STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK |
STAYHEALTHY, INC. |
COLIN HILL PHD. |
K122945 |
04/30/2013 |
STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126 |
STERITEC PRODUCTS MFG. CO., INC. |
JONATHAN RUTIGLIANO |
K130222 |
04/29/2013 |
STRAUMANN DENTAL IMPLANT SYSTEM |
STRAUMANN USA, LLC |
JENNIFER M JACKSON, MS |
K123784 |
04/10/2013 |
STRAUMANN DENTAL IMPLANT SYSTEM |
STRAUMANN USA, LLC |
JENNIFER M JACKSON, MS |
K123786 |
04/09/2013 |
STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM |
Stryker |
JAMSHED BADARPURA |
K123942 |
04/03/2013 |
STRYKER IVAS BALLOON CATHETER |
STRYKER CORPORATION |
CHRISTINA MCKEE |
K122868 |
04/19/2013 |
BIOSPHERE BIOACTIVE BONE GRAFT PUTTY |
Synergy Biomedical, LLC |
RANDY PREBULA |
K124042 |
04/02/2013 |
TANDA MINI SKINCARE SYSTEM |
SYNERON BEAUTY |
JANICE M HOGAN |
K130896 |
04/24/2013 |
VASCULAR PROBE, VASCULAR PROBE ES |
SYNOVIS LIFE TECHNOLOGIES, INC. |
STEPHANI K AYALA |
K122455 |
04/11/2013 |
SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM |
SYNTHES |
ANGELA F LASSANDRO |
K122210 |
04/19/2013 |
NEWFIX EXTERNAL FIXATION SYSTEM |
TECNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V |
ROBERT J BARD |
K121916 |
04/02/2013 |
INTUITION |
TERARECON, INC. |
ROBERT TAYLOR |
K120056 |
04/01/2013 |
HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER |
THE BINDING SITE GROUP LTD |
JILL CONSTANTINE |
K122304 |
04/15/2013 |
HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS |
THE BINDING SITE GROUP, LTD. |
JILL CONSTANTINE |
K130285 |
04/03/2013 |
PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS |
THE LAGADO CORP. |
Ellen M Beucler |
K122199 |
04/18/2013 |
PREXION3D ECLIPSE |
THE YOSHIDA DENTAL MFG. CO., LTD. |
TOSHIMITSU MURAKAMI |
K123295 |
04/24/2013 |
RHYTHM VIEW |
TOPERA, INC. |
MELISSA WALKER |
K130422 |
04/04/2013 |
PHANTOM FIBER BIOFIBER SUTURE |
TORNIER, INC. |
LAEL J PICKETT |
K123997 |
04/01/2013 |
TRANS1LATERAL INTERBODY FUSION SYSTEM |
TRANS1, INC. |
CHERYL L WAGONER |
K123777 |
04/11/2013 |
MULTILASER SYSTEM |
ULTRALIGHT LASER TECHNOLOGIES, LLC |
MARK ROHRER |
K123282 |
04/25/2013 |
DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS |
ULTRAPURE & INDUSTRIAL SERVICES LLC |
GREG FRANKS |
K123708 |
04/10/2013 |
SPINE COIL |
USA PARAMED MEDICAL SYSTEMS, INC. |
RICHARD OLSON |
K130318 |
04/22/2013 |
NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB) |
VARIAN MEDICAL SYSTEMS, X-RAY PRODUCTS-INFIMED |
CATHERINE MULCAHY |
K130406 |
04/29/2013 |
DIAGNOSTICPRO EDGE |
VIDAR SYSTEMS CORP. |
CARRIE L BRANCART |
K123467 |
04/17/2013 |
VS3 |
VISIONSENSE, LTD. |
GERARD J PRUD'HOMME |
K122826 |
04/24/2013 |
PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM; PREVIEW CATHETER MODEL 87000; PIMF MODEL 87-PIMF; LAPTOP SYSTEM |
VOLCANO CORPORATION |
LIDA QUAGLIA |
K123482 |
04/29/2013 |
REFLOW ASPIRATION CATHETER |
VOLCANO CORPORATION |
BRIAN PARK |
K130215 |
04/09/2013 |
GORE ACUSEAL VASCULAR GRAFT |
W.L. GORE & ASSOCIATES,INC |
Michael Ivey |
K123732 |
04/04/2013 |
HYSTEROSCOPY PUMP HM6 |
W.O.M. WORLD OF MEDICINE AG |
SUSANNE RAAB |
K122994 |
04/12/2013 |
INTRAMEDULLARY NAIL SYSTEM |
WEIGAO ORTHOPAEDIC DEVICE CO., LTD |
Diana Hong |
K130340 |
04/05/2013 |
LOCKING BONE PLATES AND SCREWS |
WEIGAO ORTHOPAEDIC DEVICE CO., LTD |
Diana Hong |
K123770 |
04/09/2013 |
WARMING JELLY PERSONAL LUBRICANT |
WISCONSIN PHARMACAL CO., LLC |
JOHN NYGAARD |
K123293 |
04/11/2013 |
PASTELLE Q-SWITCHED ND: YAG LASER |
WON TECHNOLOGY CO., LTD. |
Roberta Hines |
K123954 |
04/01/2013 |
INFINITY TOTAL ANKLE SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SAMIR IBRAHIM |
K130167 |
04/19/2013 |
PROFEMUR XM DISTAL CENTRALIZER |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MATT PAUL |
K130044 |
04/05/2013 |
SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
RYAN BORMANN |
K122812 |
04/11/2013 |
JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS |
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. |
DORIS DONG |
K122996 |
04/10/2013 |
ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085 |
XHALE |
DAVID RICH |
K130108 |
04/19/2013 |
DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS |
XIAMEN DOUBLE ENGINE MEDICAL MATERIAL CO., LTD |
DA ZENG |
K123387 |
04/12/2013 |
QUIKCLOT HEMOSTATIC DRESSING |
Z-MEDICA, LLC |
SHEILA WALLIN |
K130030 |
04/25/2013 |
ZAVATION CERVICAL PLATE SYSTEM |
ZAVATION LLC |
JOHN WALKER |
K123658 |
04/24/2013 |
BIOMODULE 3-M1 |
ZEPHYR TECHNOLOGY CORPORATION |
RICHARD KEEN |
K123552 |
04/19/2013 |
INSTINCT JAVA SYSTEM |
ZIMMER SPINE |
ELSA A LINKE |
K130929 |
04/12/2013 |
ZMED VP4000 |
ZMED, INC. |
RANDALL S MILLAR |
K122664 |
04/30/2013 |
ZUGA DENTAL IMPLANT SYSTEM |
ZUGA MEDICAL, INC. |
KAREN E WARDEN, PHD |