FDA 510(k) Decisions During April, 2013  

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
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