FDA 510(k) Applications Received During September, 2011

FDA 510(k) Number Submission Date Device Name Applicant Contact
K112742 09/22/2011 AUDIT MICROLQ SPINAL FLUID CONTROL AALTO SCIENTIFIC LTD. DESSI LYAKOV
K112705 09/19/2011 AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL AALTO SCIENTIFIC LTD. DESSI LYAKOV
K112892 09/30/2011 IMPELLA 2.5 PLUS CATHETER ABIOMED, INC. CAROLYN PEKAR
K112273 09/27/2011 ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR ACCUMED HEALTHCARE (SHANGHAI) INC. CYNTHIA (CINDY) GREEN
K112653 09/28/2011 ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS ACON LABORATORIES, INC. QIYI XIE
K112863 09/30/2011 ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SET, ENTERAL EXTENSION SET WITH MINITUBE CONN ACTA MEDICAL L.L.C. AARON COMPTON
K112606 09/28/2011 ACTIVATOR V-E ACTIVATOR METHODS INTERNATIONAL LTD. ARLAN W FUHR
K112585 09/06/2011 TOUAREG CLOSEFIT DENTAL IMPANT SYSTEM ADIN DENTAL IMPLANTS SYSTEM LTD YANA PRUS-GALYNSKY
K112529 09/01/2011 TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K112568 09/06/2011 AONGEN DENTAL COLLAGEN MATRIX AEON ASTRON EUROPE B.V. HORNG JI LAI
K112551 09/01/2011 S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEM, INC. LISA M BOYLE
K112682 09/15/2011 METHA HIP SYSTEM AESCULAP IMPLANT SYSTEMS, LLC KATHY A RACOSKY
K112671 09/14/2011 STERILCONTAINER SYSTEM AESCULAP, LTD. DENISE ADAMS
K112670 09/14/2011 DX-D 600 AGFA HEALTHCARE N.V. PHIL CUSCUNA
K112728 09/22/2011 HEPAIRX VENTILATING AIR PURIFIER AIR INNOVATIONS, INC. LAWRENCE WETZEL
K112538 09/01/2011 ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. HYMAN KATZ
K112811 09/27/2011 SANICLAVE 200 ALTERNATIVE PIONEERING RESEARCH AND DEVELOPMENT ISAAC ERICKSON
K112548 09/01/2011 ALTOMEC ARTHROSCOPE ALTOMEC ENDOSCOPY INC DARREN REEVES
K112842 09/29/2011 AMS ELEVATE PC AMERICAN MEDICAL SYSTEMS, INC. MATTHEW D STEPANEK
K112598 09/08/2011 AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) AMERICAN SURGICAL COMPANY, LLC MICHAEL ALOUANE
K112738 09/20/2011 ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE ANDON MEDICAL CO., LTD. YI LIN
K112600 09/07/2011 ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K112752 09/21/2011 TINNITUS THERAPY SYSTEM ANM T30 CR ANM ADAPTIVE NEUROMODULATION GMBH INGRID ROHM
K112849 09/29/2011 FIXATE TISSUE BAND ANULEX TECHNOLOGIES, INC RACHEL KENNEDY
K112734 09/20/2011 APLAN A.V. FISTULA NEEDLE SET APLAN WELL ENTERPRISE CO., LTD JEN KE-MIN
K112896 09/30/2011 ARRW EVOLUTION ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) TRACY MADDOCK
K112675 09/14/2011 ARROW-LOK DIGITAL SYSTEM ARROWHEAD MEDICAL DEVICE TECHNOLOGIES LLC THOMAS J TWARDZIK
K112438 09/07/2011 TITAN MODULAR TOTAL SHOULDER SYSTEM ASCENSION ORTHOPEDIC SUSAN WALTON
K112669 09/29/2011 TATTOOSTAR EFFECT Y ASCLEPION LASER TECHNOLOGIES GMBH ANTJE KATZER
K112759 09/22/2011 APCLO PEDICLE SCREW SYSTEMS ATLAS SPINE INC. THOMAS G SMITH
K112579 09/06/2011 WILDCAT 5F GUIDEWIRE SUPPORT CATHETER AVINGER, INC. SEVRINA CIUCCI
K112825 09/28/2011 AVITA ARM TYPE BLOOD PRESSURE MONITOR AVITA CORPORATION JENNIFER REICH
K112790 09/26/2011 AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON AXIS-SHIELD DIAGNOSTICS, LTD. KAREN HILL
K112636 09/09/2011 CYTOGUARD(TM) CLOSED LUER CONNECTOR B. BRAUN MEDICAL, INC. ANGELA J CARAVELLA
K112603 09/07/2011 ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS BECKMAN COULTER, INC. CINDY MCGUIRE
K112586 09/06/2011 CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM) BECTON DICKINSON AND COMPANY (BD) KATIE COYLE
K112774 09/23/2011 BD RECYKLEEN SHARPS COLLECTORS BECTON, DICKINSON AND COMPANY EILEEN HILLER
K112622 09/08/2011 HANDHELD ECG MONITOR BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. DIANA HONG
K112799 09/27/2011 MED-RX EXTENSION SET WITH T-CONNECTOR BENLAN INC CHERYL BROWN
K112623 09/08/2011 AIRLIGHT DENTAL HANDPIECE BEYES DENTAL CANADA INC ANTHONY HOPKINS
K112869 09/30/2011 EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400 BEYES DENTAL CANADA INC ANTHONY HOPKINS
K112810 09/27/2011 MULTI-ANALYTE DETECTION SYSTEMS BIO-RAD LABORATORIES JUANG WANG
K112817 09/28/2011 MICROEEG SYSTEM BIO-SIGNAL GROUP CORPORATION ANDERSON MICU
K112818 09/28/2011 VIDAS D-DIMER EXCLUSION II (DEX2) BIOMERIEUX, INC. VERONICA DAENZER
K112567 09/07/2011 BIOMERIX ASSURE BIOMERIX CORPORATION CHRISTINA L KICHULA
K112730 09/20/2011 ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION BIOMET 3I MAYANK CHOUDHARY
K112857 09/30/2011 INTERFACE BONE VOID FILLER BIOSTRUCTURES, LLC KEVIN A THOMAS
K112875 09/30/2011 BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS BLUE SKY BIO, LLC MICHELE VOVOLKA
K112701 09/16/2011 CHARGER BALLOON DILATATION CATHETER BOSTON SCIENTIFIC GLENN JACQUES
K112697 09/16/2011 CHARGER PTA BALLON DILATATION CATHETER BOSTON SCIENTIFIC GLENN JACQUES
K112745 09/21/2011 V-14 CONTROL WIRE GUIDEWIRE BOSTON SCIENTIFIC CORPORATION SHANNON PETTIT
K112543 09/01/2011 WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM BOSTON SCIENTIFIC CORPORATION THOMAS HIRTE
K112497 09/02/2011 MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT C.R. BARD, INC. JONI CREAL
K112744 09/21/2011 SAPIENS TIP CONFIRMATION SYSTEM C.R. BARD, INC. HENRY BOLAND
K112609 09/08/2011 DESARA MESH CALDERA MEDICAL, INC. VICKI GAIL
K112768 09/22/2011 CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING CALYPSO MEDICAL TECHNOLOGIES INC MARCIA PAGE
K112841 09/29/2011 SURFACE BEACON TRANSPONDERS CALYPSO MEDICAL TECHNOLOGIES INC MARCIA PAGE
K112715 09/20/2011 CANDELA GENTLEMAX FAMILY OF LASERS CANDELA CORP. SAM WADE
K112831 09/28/2011 PLEURX PLEURAL CATHETER SYSTEMS CAREFUSION JOY GREIDANUS
K112535 09/01/2011 GENESIS REUSABLE RIGID CONTAINER SYSTEM CAREFUSION 2200, INC. KATE FULLER
K112820 09/28/2011 FORE-SIGHT ABSOLUTE TISSUE OXIMETER CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K112814 09/27/2011 CUFFINK CAYENNE MEDICAL, INC. KERESHMEH SHAHRIARI
K112876 09/30/2011 CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5 CAYENNE MEDICAL, INC. KERESHMEH SHAHRIARI
K112864 09/30/2011 SOFTSEAL-C CHITOGEN, INC. JAMES F DRAKE
K112743 09/21/2011 SAME/VARIOUS DISTRIBUTORS/WE MAY PRIVATE LABEL CLEAN MEDICAL MANFACTURING CO;LTD AARON RICHARD
K112796 09/26/2011 SURGICAL GOWN (EO STERILIZED) COBES INDUSTRIES CO., LTD. LEON LU
K112828 09/29/2011 REVIVE INTERMEDIATE CATHETER (REVIVE IC) CODMAN & SHURTLEFF, INC. CATHERINE KILSHAW
K112860 09/30/2011 PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER COLOPLAST A/S BRIAN SCHMIDT
K112838 09/28/2011 VASOPRESS REPROCESSED DVT LEG / FOOT GARMENTS COMPRESSION THERAPY CONCEPTS, INC. LEONARD NASS
K112780 09/27/2011 CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA S SHAH
K112650 09/12/2011 CONNEXALL SUITE OF SOFTWARE PRODUCTS CONNEXALL USA, INC. THOMAS KROENKE
K112797 09/26/2011 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER CORDIS CORP. DANNA MARSHALL
K112549 09/01/2011 IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER COVALON TECHNOLOGIES, INC. KIM CROOKS
K112536 09/01/2011 SONICISION STERILIZATION TRAY COVIDIEN DAVID M HORTON
K112791 09/26/2011 SITESCRUB IPA DEVICE CR BARD LYNN M KIRCHOFF
K112677 09/14/2011 THE VENOUS ASSIST SYSTEM DAESUNG MAREF CO., LTD. DANIEL NAM
K112580 09/06/2011 COLLAGEN WOUND DRESSING DALIM TISSEN CO., LTD. APRIL LEE
K112722 09/19/2011 GE DATEX-OHMEDA AVANCE DATEX-OHMEDA, INC. JIM RASKOB
K112547 09/01/2011 NEO NEST DENOVO PROUCTS LLC DALE WALTERS
K112725 09/20/2011 LIAISON 25 OH VITAMIN D TOTAL ASSAY DIASORIN, INC. JUDI SMITH
K112755 09/21/2011 ABACUS 5 DIATRON US INC MICHAEL SWITZER
K112746 09/21/2011 DIOSLIMON IMPLANT SYSTEM DIO CORPORATION TIMOTHY LEE
K112874 09/30/2011 EZ VEIN INFLATABLE TOURNIQUET DOMINION MEDICAL DEVICES, LLC ELAINE DUNCAN
K112723 09/19/2011 EPLGRAY DOSLSOFT SA ROBERT J MORTON
K112868 09/30/2011 DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX DREAMGARD, INC. SUZAN ONEL
K112694 09/15/2011 EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER EDWARDS LIFESCIENCES, LLC. SPENCER WALKER
K112645 09/12/2011 RADIFORCE LARGE MONITOR SYSTEM EIZO GMBH BERND HOMBERG
K112613 09/07/2011 INTEGRITY(TM) ELEKTA LIMITED ANDREW HEDGES
K112576 09/06/2011 ENDOCHOICE WATER BOTTLE CAP SYSTEM ENDOCHOICE, INC. THERON GOBER
K112663 09/13/2011 ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL ENHATCH ORTHOPAEDICS LLC MICHAEL PHIPPS
DEN110016 09/21/2011 PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS ETHICON ENDO-SURGERY THOMAS BOSTICCO
K112733 09/20/2011 ER35 ERO-SCAN PRO HEARING TEST SYSTEM ETYMOTIC RESEARCH, INC. JACK KENT
K112832 09/29/2011 EYE CARE CURE CONTACT LENS CASE EYE CARE AND CURE LINDY V DALEN
K112766 09/22/2011 SNORKEL FELLMAR COMPANY WAYNE MARSHALL
K112621 09/08/2011 WIS1000 FORESEESON CUSTOM DISPLAYS, INC. DANIEL TOMLINSON
K112880 09/30/2011 CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE FREEDOM MEDITECH, INC. CRAIG H MISRACH
K112570 09/06/2011 CENTRICITY CARDIO IMAGING GE HEALTHCARE INTEGRATED IT SOLUTIONS JOHN MANARIK
K112572 09/06/2011 GEISTLICH COMBI-KIT COLLEGEN GEISTLICH PHARMA AG DANIEL A KRACOV
K112575 09/06/2011 GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO GEISTLICH PHARMA AG DANIEL A KRACOV
K112856 09/30/2011 LUCINA-MELODI GENADYNE BIOTECHNOLOGIES, INC. CHIEN-MING GOH
K112716 09/19/2011 OSTEON II GENOSS CO., LTD. SUNGWON LEE
K112756 09/26/2011 FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS GLOBUS MEDICAL, INC. KELLY J BAKER
K112877 09/30/2011 COMEN MULTI-PARAMETER PATIENT MONITOR GOLDWAY (US), INC. JIMMY WU
K112541 09/01/2011 Z FLEX-270TM STEERABLE SHEATH GREATBATCH MEDICAL SARA BAKKER
K112804 09/27/2011 FINGERTIP PULSE OXIMETER GUANGDONG BIOLIGHT MEDITECH CO., LTD. DIANA HONG
K112803 09/27/2011 PATIENT MONITOR GUANGDONG BIOLIGHT MEDITECH CO., LTD. DIANA HONG
K112844 09/29/2011 REHASTIM 2, REHAMOVE 2 HASOMED GMBH MATTHIAS WEBER
K112616 09/08/2011 NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS HEINZ KURZ GMBH MEDIZINTECHNIK KRISTINA BITZER
K112858 09/30/2011 GENESIS TOUCH SYSTEM HONEYWELL HOMMED, LLC CLAUDIA JACKSON
K112556 09/02/2011 ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS HOWMEDICA OSTEONICS CORP VALERIE GIAMBANCO
K112800 09/27/2011 SUNTOUCH TOPICAL HEMOSTATIC DRESSING HUIZHOU FORYOU MEDICAL DEVICES CO, LTD CHENGYU SHEN
K111938 09/14/2011 IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL... IMMUNODIAGNOSTIC SYSTEMS LTD. MICK FENTON
K112702 09/16/2011 IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS IMPERIAL SURGICAL LTD. KATHRYN RONALDS
K112634 09/09/2011 NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP INOTEC AMD LTD. DIANE HORWITZ
K112545 09/09/2011 QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM INOVA DIAGNOSTICS, INC. MICHAEL MAHLER
K112610 09/07/2011 SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS) INPRO TECHNOLOGY DEVICE FACTORY MEIXIA WANG
K112599 09/07/2011 INSURGICAL SINGLE USE POWER EQUIPMENT INSURGICAL LLC DAVID C FURR
K112601 09/14/2011 INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER INTRICON DATRIX CORPORATION TANYA O'BRIEN
K112584 09/06/2011 5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT INTUITIVE SURGICAL, INC. KIM T SERVANCE
K112263 09/12/2011 MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY INTUITIVE SURGICAL, INC. BRANDON HANSEN
K112665 09/16/2011 TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE J. MORITA USA, INC. KEITH A BARRITT
K112812 09/27/2011 LEFORTE NEURO SYSTEM BONE PLATE JEIL MEDICAL CORPORATION PAUL SUMNER
K112806 09/28/2011 JENSEN ZIRCONIA JENSEN INDUSTRIES, INC. GARY PHELPS
K112480 09/01/2011 VIEW 1 IMAGING KARL STORZ ENDOSCOPY AMERICA, INC. WINKIE WONG
K112758 09/22/2011 KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X10 KAT IMPLANTS, LLC VITALI BONDAR
K112888 09/30/2011 MESO WOUND MATRIX KENSEY NASH CORPORATION LORI A BURNS
K112562 09/26/2011 BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER KIMBERLY-CLARK DAVID LEE
K112805 09/27/2011 KIMGUARD ONE-STEP STERILIZATION WRAP KIMBERLY-CLARK CORP. BRENDA SHELKEY
K112635 09/09/2011 U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS KIMBERLY-CLARK CORP. SWARNA MUKUND
K112695 09/28/2011 CRYOTOP KITAZATO BIOPHARMA CO;LTD RICHARD VINCINS CQA,RAC(US,EU)
K112787 09/26/2011 KERATOR KJ MEDITECH CO., LTD PRICILLA CHUNG
K112643 09/12/2011 FOCUS MIS SYSTEM L & K BIOMED CO., LTD HEE K JOO
K112539 09/01/2011 CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE LEIKER REGULATORY & QUALITY CONSULTING BOB LEIKER
K112711 09/19/2011 NEBA SYSTEM LEXICOR MEDICAL TECHNOLOGY, LLC E. HOWARD MERRY
K112534 09/01/2011 LIFECELL TISSUE EXPANDER LIFECELL CORP. KRISTEN MEANY
K112741 09/21/2011 POWDER FREE VINYL PATIENT EXAMINATION GLOVE LIFESTYLE SAFTY PRODUCTS (HUI ZHOU) CO. LTD RHONDA T ALEXANDER
K112644 09/12/2011 SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM LOTUS BIO LTD LORI KAHLER
K112781 09/26/2011 TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I) LUMINEX MOLECULAR DIAGNOSTICS, INC. LUBNA SYED
K112679 09/14/2011 SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM MATERIALISE DENTAL NV CARL VAN LIERDE
K112720 09/19/2011 MCKESSON HORIZON CARDIOLOGY MCKESSON ISRAEL LTD. TOMER LEVY
K112703 09/16/2011 SHAKER DIGITAL THERMOMETER MEASURE TECHNOLOGY CO. LTD. RACK YU
K112862 09/30/2011 MECTA-C MEDACTA INTERNATIONAL ADAM GROSS
K112559 09/02/2011 MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM MEDAPPS, INC. KENT DICKS
K112560 09/02/2011 APTUS(R) DISTAL HUMERUS SYSTEM MEDARTIS AG KEVIN A THOMAS
K112788 09/26/2011 EASTLYTE NA/K/CA/PH MEDICA CORP. PHOTIOS MAKRIS
K112648 09/28/2011 ASFORA BULLET CAGE MEDICAL DESIGNS, LLC KRISTI VONDRA
K112727 09/20/2011 MEDICAL FACETS CORICAL SCREWS, MEDICAL FACETS CANCELLOUS SCREWS, MEDICAL FACETS HEADLESS COMPRESSION SCREWS, MEDICAL MEDICAL FACETS GLENN A RUPP
K112626 09/09/2011 LIPSONIX(R) SYSTEM MODEL 2 MEDICIS TECHNOLOGIES CORPORATION MICHAEL A HOFFMAN
K112807 09/27/2011 X-RAY VVA MEDIS MEDICAL IMAGING SYSTEMS, B.V. D.J.W. BIERHUIZEN
K112769 09/23/2011 CURAD COMPRESSION HOSIERY MEDLINE, INDUSTRIES, INC. MATT CLAUSEN
K112724 09/19/2011 DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM MEDOS INTERNATIONAL SARL EUGENE BANG
K112555 09/02/2011 CD HORIZON(R) SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. CHRIS MCKEE
K112473 09/27/2011 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. CHRIS MCKEE
K112662 09/13/2011 MICROFRANCE(R) WORMALD VASCULAR CLAMP MEDTRONIC XOMED, INC. MARSHA SEETARAM
K112686 09/15/2011 NEXT GEN EMG ENDOTRACHEAL TUBE MEDTRONIC XOMED, INC. MAREK PAWLOWSKI
K112845 09/29/2011 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K112627 09/09/2011 MILLENIUM ANTI-SNORING DEVICE MILLENIUM DENTAL LABORATORY, INC NGHIEP V NGUYEN
K112782 09/26/2011 MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES MISONIX, INC. RONALD R MANNA
K112826 09/28/2011 NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR MOOR INSTRUMENTS LTD. XIABING HUANG HUANG
K112597 09/07/2011 SEITY 37% PHOSPHORIC ACID ETCHANT GEL MYCONE DENTAL SUPPLY CO., INC. WILLIAM EVANS
K112673 09/14/2011 PROPHY-MATE NEO NAKANISHI, INC. DIANE RUTHERFORD
K112666 09/13/2011 SALINE WOUND WASH NANOPLAS, INC. RYAN LYTLE
K112674 09/14/2011 NAVIS TORQUER NAVIS MEDICAL,INC MATTHEW J HUDDLESTON
K112540 09/01/2011 S-MINI IMPLANT SYSTEM NEOBIOTECH CO., LTD. APRIL LEE
K112881 09/30/2011 NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM) NEXSTIM OY RAINER HARJUNPAA
K112637 09/09/2011 NETKONNECT REMOTE NETWORK EXTENSION NIHON KOHDEN STEVE GEERDES
K112690 09/15/2011 BLOOD PRESSURE MONITOR NIHON SEIMITSU SOKKI CO., LTD. KOJI KUBO
K112691 09/15/2011 BLOOD PRESSURE MONITOR NIHON SEIMITSU SOKKI CO., LTD. KOJI KUBO
K112620 09/08/2011 DISITAL BLOOD PRESSURE MONITOR NIHON SEIMITSU SOKKI CO., LTD. KOJI KUBO
K112770 09/23/2011 NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER NINEPOINT MEDICAL, INC CINDY DOMECUS
K112628 09/09/2011 NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET NIPRO MEDICAL CORPORATION JESSICA OSWALD
K112843 09/29/2011 PULSE OXIMETER NONIN MEDICAL, INC. BRODIE PEDERSON
K112830 09/28/2011 ZOEFLUID STATUS MONITOR (MODEL ZOE 2B) NONINVASIVE MEDICAL TECHNOLOGIES, INC. MARC O'GRIOFA
K112713 09/28/2011 NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS NORFOLK MEDICAL PRODUCTS, INC. MICHAEL DALTON
K112890 09/30/2011 NORMATEC MVP NORMATEC INDUSTRIES, LP JONATHAN KAHAN
K112638 09/09/2011 NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS NOVA BIOMEDICAL CORPORATION PAUL W MACDONALD
K112773 09/23/2011 NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT NOVABONE PRODUCTS, LLC DAVID M GAISSER
K112565 09/02/2011 NOVAPORT ONE VASCULAR ACCESS CANNULA NOVALUNG GMBH LEANN CHRISTMAN
K112561 09/02/2011 NUVASIVE COROENT NO-PROFILE SYSTEM NUVASIVE, INC. SHEILA BRUSCHI
K112717 09/19/2011 NUVASIVE NVJJB SYSTEM NUVASIVE, INC. ELIAS KETCHUM
K112718 09/19/2011 NUVASIVE NVM5 SYSTEM NUVASIVE, INC. ELIAS KETCHUM
K112709 09/19/2011 STIMULATION/DISSECTION INSTRUMENTS NUVASIVE, INCORPORATED ELIAS KETCHUM
K112546 09/01/2011 O_TWO CPAP SYSTEM O-TWO MEDICAL TECHNOLOGIES, INC. AMMAR AL-DOJAILY
K112564 09/02/2011 QUIXIE NEBULIZER ODYSSEY MEDICAL TECHNOLOGIES DAVID PIPER
K112680 09/14/2011 EVIS EXERA III VIDEO SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION STACY ABBATIELLO KLUESNER
K112808 09/27/2011 OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES OMEGA LABORATORIES, INC. ROBERT J BARD
K112891 09/30/2011 APEX REVISION KNEE SYSTEMS OMNI LIFE SCIENCE, INC. CHRISTINE NASSIF
K112779 09/26/2011 APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM) OMNLIFE SCIENCE CHRISTINE NASSIF
K112629 09/09/2011 ONSET ACCESS CATHETER SYSTEM ONSET MEDICAL CORPORATION JOSEPH BISHOP
K112640 09/12/2011 HYPERELASTIC WIRE ORMCO CORP. WENDY GARMAN
K112707 09/19/2011 GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM ORTHO TECHNOLOGY, INC JODI HUTCHINS
K112658 09/13/2011 OSTEOSPRING FOOTJACK SUBTALAR IMPLANT SYSTEM OSTEOSPRING MEDICAL, INC J.D. WEBB
K112795 09/26/2011 PALTOP DENTAL IMPLANT SYSTEM PALTOP ADVANCED DENTAL SOLUTIONS LTD TAL HAMMER-TOPAZ
K112595 09/07/2011 COFLEX-F PARADIGM SPINE, LLC MARC VISCOGLIOSI
K112859 09/30/2011 ERAPID NEBULIZER SYSTEM PARI RESPIRATORY EQUIPMENT, INC. JAMES L MCINTIRE
K112652 09/12/2011 SURESIGNS VS2+ -SURESIGNS VSI PHILIPS MEDICAL SYSTEMS MARY KRUITWAGEN
K112757 09/22/2011 PIONEER POSTERIOR CERVICO THORACIC SYSTEM PIONEER SURGICAL TECHNOLOGY, INC. EMILY M DOWNS
K112802 09/27/2011 PIPELINE TOTAL HIP SYSTEM PIPELINE ORTHOPEDICS TERRY POWELL
K112573 09/06/2011 EZSLEEP SLEEP QUALITY RECORDER PLATINUM TEAM CO., LTD JAMES HO
K112763 09/22/2011 MATRIXBRUSH ENDOMETRIAL SAMPLER POST OAK INNOVATIONS, INC. HEATHER CRAWFORD
K112815 09/27/2011 QUANTUM BARIATRIC 451 PRIDE MOBILITY PRODUCT CORPORRATION KIMBERLY BLAKE
K112574 09/06/2011 PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT PRIME DENTAL MANUFACTURING, INC. JAVIER ALVAREZ
K112654 09/12/2011 POWDERFREE POLYISOPRENE SURGICAL GLOVES PT. MEDISAFE TECHNOLOGIES ANIL TANEJA
K112801 09/27/2011 AYERS ROCK CERVICAL CAGE QUALGENIX RICHARD DESLAURIERS
K112684 09/15/2011 MONT BLANC PEDICLE SCREW SYSTEMS QUALGENIX RICHARD DESLAURIERS
K112696 09/15/2011 TWIN PEAKS LUMBAR CAGE QUALGENIX LLC RICHARD DESLAURIERS
K112824 09/28/2011 QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER QUALITY LIFE TECHNOLOGIES CO;LTD LEON LU
K112879 09/30/2011 REST ASSURED READY TO WEAR NITE PROTECTOR RANIR LLC GERARD J PRUD'HOMME
K112489 09/29/2011 SWIFT FX BELLA RESMED LTD. KIM K LEE
K112624 09/08/2011 ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5 ROCHE DIAGNOSTICS JANE PHILLIPS
K112822 09/28/2011 SLEEPSTRIP II S.L.P LTD. NOAM HADAS
K112591 09/07/2011 SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS SAFE SECURE PACKAGING CO., LTD GARFIELD WANG
K112646 09/12/2011 SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM SAMSUNG MEDISON CO., LTD KYEONG-MI PARK
K112558 09/02/2011 DIGITAL FLAT PANEL X-RAY DETECTOR SAMSUNG MOBILE DISPLAY CO., LTD DAVE KIM
K112751 09/21/2011 SDX-4343CS SAMSUNG MOBILE DISPLAY CO., LTD DAVE KIM
K112872 09/30/2011 STATIM 2000 G4 CASSETTE SCICAN LTD. TERESA BOYCE
K112550 09/01/2011 CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM SEBIA KAREN ANDERSON
K112693 09/15/2011 NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES SGMP CO., LTD. JANNA P TUCKER
K112798 09/27/2011 LOCKING COMPRESSION PLATE SYSTEM SHANGHAI MICROPORT ORTHOPEDICS CO., LTD JASON MA
K112827 09/28/2011 SHEATHES ULTRASOND GEL SHEATHING TECHNOLOGIES, INC. JENNIFER DOWNING
K112596 09/07/2011 ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI SHELLY PEARCE
K112611 09/07/2011 SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS SINTEA PLASTEK, LLC DANIELLE WERNIKOWSKI
K112861 09/30/2011 SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM SINTEA PLUSTEK, LLC DANIELLE WERNIKOWSKI
K112672 09/14/2011 HEADLESS COMPRESSION SCREW SKELETAL DYNAMICS, LLC ANA M ESCAGEDO
K112784 09/26/2011 RENASYS AB ABOMINAL DRESSING KIT SMITH & NEPHEW, INC. LAURA D REYNOLDS
K112526 09/01/2011 TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS SMITH & NEPHEW, INC. MELISSA EGAN
K112407 09/07/2011 SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS SMITHS MEDICAL MD, INC. TOM BLISS
K112777 09/28/2011 SOL-M EXCHANGEABLE NEEDLES SOL-MILENNIUM MEDICAL, INC. JIM BARLEY
K112683 09/15/2011 SMI CARDIOVASCULAR PACH SOLIMAS MEDICAL, INC. MICHEAL KOLBE
K112602 09/07/2011 S6 DIAGNOSTIC ULTRASOUND SYSTEM SONOSCAPE COMPANY LIMITED DIANA HONG
K112771 09/23/2011 BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG SORIN GROUP ITALIA S.R.L. SCOTT LIGHT
K112729 09/20/2011 BLEASE700/900 SERIES VENTILATORS SPACELABS HEALTHCARE THOMAS KROENKE
K112870 09/30/2011 CLEARBLUE ADVANCED PREGNANCY TEST WITH WEEKS ESTIMATOR SPD SWISS PRECISION DIAGNOSTICS GMBH LOUISE ROBERTS
K112748 09/21/2011 SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM SPINAL USA LLC FRANKIE CUMMINS
K112607 09/07/2011 SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE ... SPINEVISION, S.A. DONALD W GUTHNER
K112688 09/15/2011 ENSITE VELOCITY SYSTEM V.3.0 ST. JUDE MEDICAL DONNA R LUNAK
K112813 09/27/2011 AMSCO V-PRO STERIS CORP. ROBERT SULLIVAN
K112760 09/22/2011 AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM STERIS CORPORATION ROBERT SULLIVAN
DEN110006 09/06/2011 VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR STERIS Corporation ROBERT SULLIVAN
K112557 09/02/2011 STRYKER UNIVERSAL NEURO 3 SYSTEM STRYKER ROB YAMASHITA
K112593 09/20/2011 STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM STRYKER CORPORATION MICHELLE JUMP
K112659 09/19/2011 SURGICAL RETRACTORS SURGICAL INNOVATIONS PLC STEPHEN SEED
K112853 09/29/2011 VOLTERA POWERED SUCTION PUMP SUZRIC ENTERPRISE CO., LTD. MICHAEL LEE
K112786 09/27/2011 PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF SYNOVIS ORTHOPEDIC AND WOUNDCARE, INC. AMY BOUCLY
K112583 09/06/2011 SYNTHES CORTICAL SCREWS SYNTHES (USA) PRODUCTS LLC REBECCA BLANK
K112689 09/15/2011 SYNTHES STERNAL FIXATION SYSTEM SYNTHES INC ELIZABETH KIERZEK
K112605 09/07/2011 SYSMEX XN-SERIES SYSMEX AMERICA, INC. SHARITA BROOKS
K112704 09/16/2011 LIPIFLOW THERMAL PULSATION SYSTEM TEARSCIENCE, INC. CHRISTY STEVENS
K112554 09/02/2011 TRANSRADIAL ARTERY ACCESS DEVICES TELEFLEX MEDICAL, INC. CHRISTINE FORD
K112587 09/06/2011 ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR, TERUMO CARDIOVASCULAR SYSTEMS CORP. REBECCA ANDERSEN
K112776 09/26/2011 TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER TOMOTHERAPY INCORPORATED GREG BANGE
K112612 09/07/2011 POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM TOP CALIBRE SDN BHD TRACY NGUI
K112615 09/12/2011 AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM TORNIER, INC. BRAHIM HADRI
K112604 09/07/2011 21.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356) TOTOKU ELECTRIC CO., LTD TSUKASA TASHIRO
K112657 09/13/2011 AUREFLO MONITORING SYSTEM TRANSONIC SYSTEMS, INC. DAVID KLEMENTOWSKI
K112737 09/20/2011 TIGER HEADLESS CANNULATED SCREWS TRILLIANT SURGICAL LTD J D WEBB
K112794 09/26/2011 EOS SMALL BONE FIXATION SYSTEM TRIMED, INC. DOUG STEINBERGER
K112726 09/20/2011 SONIX ULTRASOUND SCANNER ULTRASONIX MEDICAL CORPORATION CHAS YU
K112544 09/01/2011 UNIMED BLOOD PRESSURE CUFF UNIMED MEDICAL SUPPLIES INC. XINMEI TAN
K112698 09/16/2011 CONCENTRIC BALLOON GOOGLE UNITED STATES ENDOSCOPY GROUP, INC. CARROLL L MARTIN
K112887 09/30/2011 UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR UPSTREAM PERIPHERAL TECHNOLOGIES JANICE M HOGAN
K112886 09/30/2011 UPSTREAM SUPPORT CATHETER UPSTREAM PERIPHERAL TECHNOLOGIES JANICE M HOGAN
K112778 09/26/2011 SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING VARIAN MEDICAL SYSTEMS VY TRAN
K112839 09/28/2011 VARIAN HIGH ENERGY LINEAR ACCELERATOR VARIAN MEDICAL SYSTEMS VY TRAN
K112631 09/12/2011 VSI GUIDEWIRE VASCULAR SOLUTIONS, INC. MELINDA SWANSON
K112571 09/06/2011 XL EXTRACTION CATHETER VASCULAR SOLUTIONS, INC. MATT NIENSTEDT
K112783 09/26/2011 MANUJET III VBM MEDIZINTECHNIK GMBH ANKE BLOCHER
K112834 09/28/2011 MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES VERICHEM LABORATORIES, INC. ANTHONY JAMES DIMONTE
K112754 09/21/2011 IVENT101 VERSAMED MEDICAL SYSTEMS LTD. SHLOMI DELER
K112837 09/28/2011 VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE) VILEX, INC. SYLVIA SOUTHARD
K112661 09/19/2011 VIZION DR VIZTEK LLC DANIEL KAMM
K112642 09/12/2011 AQUILEX FLUID CONTROL SYSTEM H112 W.O.M. WORLD OF MEDICINE AG SUSANNE RAAB
K112687 09/15/2011 CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES WELCH ALLYN, INC. KEVIN CROSSEN
K112710 09/19/2011 ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K112647 09/12/2011 BESTSHAPE BLOOD PRESSURE MONITORING SYSTEM WISTRON CORPORATION TELING HSU
K112772 09/23/2011 ORTHOLOC(TM) BONE SCREWS WRIGHT MEDICAL TECHNOLOGY, INC. KELLEN HILLS
K112592 09/07/2011 AXLE PEEK INTERSPINOUS FUSION SYSTEM X-SPINE SYSTEMS, INC DAVID KIRSCHMAN
K112819 09/28/2011 RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW XIAMEN DOUBLE ENGLINE MEDICAL MATERIAL CO., LTD DIANA HONG
K112475 09/08/2011 XTRACT SYRINGE KEY SYSTEM XTRACT SOLUTIONS KEITH LOWREY
K112542 09/01/2011 YOMURA SAFETY I.V. CATHETER YOMURA TECHNOLOGIES INC. SHERRY LIN
K112664 09/28/2011 ZAVATION IBF SYSTEMS ZAVATION LLC JOHN WALKER
K112816 09/28/2011 ZHENJIANG ASURE MECHANICAL WHEELCHAIR ZHENJIANG ASSURE MEDICAL EQUIPMENT CO., LTD JEN KE-MIN
K112885 09/30/2011 ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY ZIMMER, INC. STEPHEN H MCKELVEY
K112660 09/13/2011 POCKETCPR ZOLL MEDICAL CORP. ROBERT MORSE
K112761 09/22/2011 ZOLL PROPAQ MD ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS CHARLES W KOLIFRATH


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact