FDA 510(k) Applications Received During November, 2012

FDA 510(k) Number Submission Date Device Name Applicant Contact
K123448 11/13/2012 AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE MEDTRONIC INC. JULIA A NELSON
K123546 11/19/2012 3M ATTEST(TM) AUTO-READER 3M COMPANY SUZANNE LEUNG
K123679 11/30/2012 3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING 3M COMPANY JOANN HUEHN
K123379 11/01/2012 ABBOTT ARCHITECT FREE T4 ABBOTT LABORATORIES JACEK GORZOWSKI
K123089 11/02/2012 FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001 ABBOTT LABORATORIES DAVID G LAMBERT
K122553 11/05/2012 MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM ACON LABORATORIES, INC. QIYI XIE
K123659 11/30/2012 TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR) ACTUATED MEDICAL, INC. DEBORA DEMERS, PHD
K123133 11/13/2012 BARLE TISSUE ADHESIVE ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD MICHAEL BROWNE
K123569 11/20/2012 ANTEGRADE FEMORAL NAIL ADVANCED ORTHOPAEDIC SOLUTIONS, INC. JULIE GLENDRANGE
K123418 11/07/2012 GRAM-NEGATIVE QUICKFISH BC ADVANDX, INC. BENJAMIN S CRYSTAL
K123683 11/30/2012 NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR AEROCRINE AB KATHLEEN RICKARD, MD
K123352 11/07/2012 S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS, INC. LISA M BOYLE
K123419 11/06/2012 EVA SELECT DIGITAL DENTAL IMAGING SYSTEM AFP IMAGING CORP. DANIEL KAMM, P.E.
K123645 11/23/2012 AGE AUTOMATIC WRIST BLOOD PRESSURE MONITOR AGELESS HEALTH INDUSTRIAL VICTOR WAN
K123308 11/13/2012 PULSTAR LOGIX INTERMITTENT PNEUMATIC COMPRESSION SYSTEM ALBAHEALTH, L.L.C. PATRICK FRANK
K123623 11/23/2012 ILLICO MIS POSTERIOR FIXATION SYSTEM ALPHATEC SPINE, INC. NADINE SMITH
K123610 11/21/2012 E-CUBE 15 ALPINION MEDICAL SYSTEMS CO., LTD DONGHWAN KIM
K123611 11/21/2012 E-CUBE 7 ALPINION MEDICAL SYSTEMS CO., LTD DONGHWAN KIM
K123519 11/15/2012 INVIVO DENTAL ANATOMAGE, INC MIKE MENDEZ
K123613 11/23/2012 SYNSPAR ADVANCED ARDENT INC DONNA M HARTNETT
K123618 11/23/2012 AXERA 2 ACCESS SYSTEM ARSTASIS, INC. DEBRA COGAN
K123241 11/07/2012 ARTHREX FRACTURE PLATES ARTHREX, INC. COURTNEY SMITH
K123462 11/09/2012 OCELOT CATHETER AVINGER, INC. ALBERT BONISKE
K123532 11/16/2012 OCELOT PIXL CATHETER AVINGER, INC. BABU PERIASAMY
K123254 11/14/2012 ULTRASOUND SCANNER FLEX FOCUS B-K MEDICAL APS RANDI HAUERBERG
K123300 11/02/2012 BD PEN NEEDLE BECTON DICKINSON & CO. PASQUALE AMATO
K123404 11/05/2012 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML) BECTON, DICKINSON & CO. MONICA E GIGURERE
K123435 11/07/2012 IPL THERAPY SYSTEM BEIJING SINCOHEREN S&T DEVELOPMENT CO LTD MIKE GU
K123483 11/13/2012 DIODE LASER BEIJING SYNTECH LASER CO., LTD. DIANA HONG
K123663 11/28/2012 LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK BIO-RAD LABORATORIES SUZANNE PARSONS
K123491 11/13/2012 BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT BIODENTA SWISS AG DAVID EILER
K123512 11/13/2012 BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM BIODENTA SWISS AG DAVID EILER
K123415 11/05/2012 BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED BIODENTA SWISS AG DAVID EILER
K123620 11/23/2012 FILMARRAY RESPIRATORY PANEL (RP) BIOFIRE DIAGNOSTICS, INC. BETH LINGENFELTER
K123549 11/19/2012 POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM BIOMET SPINE (AKA EBI, LLC) VIVIAN KELLY, MS, RAC
K123451 11/09/2012 POLARIS SPINAL SYSTEM - BALLISTA II RODS BIOMET SPINE (AKA EBI, LLC) VIVIAN KELLY MS, RAC
K123485 11/13/2012 JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF BIOMET SPORTS MEDICINE ELIZABETH WRAY
K123501 11/13/2012 OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS BIOMET, INC. GARY BAKER
K123449 11/09/2012 BIOMONDE LARVAE BIOMONDE (A TRADING NAME OF ZOOBIOTIC LIMITED) ROSINA ROBINSON RN, MED, RAC
K123636 11/23/2012 H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE BIONESS, INC. KIM TOMPKINS
K123411 11/05/2012 LITTLE ANGELS SWADDLING BLANKET BIONIX DEVELOPMENT CORP. JAMES HUTTNER
K123559 11/26/2012 SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM BIOTEST MEDICAL CORP. FRED LEE
K123653 11/27/2012 SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED) BISCO, INC. MICHELLE SCHILTZ-TAING
DEN120022 11/07/2012 X-RAY ATTENUATING CREAM BLOXR CORPORATION RAI CHOWDHARY
K123422 11/07/2012 X-RAY ATTENUATING CREAM BLOXR CORPORATION RAI CHOWDHARY
K123380 11/01/2012 STRIDE UNICONDYLAR KNEE BLUE BELT TECHNOLOGIES, INC. RICK CONFER
K123535 11/16/2012 ILAB ULTRASOUND IMAGING SYSTEM BOSTON SCIENTIFIC CORP. LORI R SMITH
K123424 11/30/2012 MDU5 PLUS STERILE BAG BOSTON SCIENTIFIC CORP. LORI R SMITH
K123621 11/23/2012 OPTICROSS 40 MHZ CORONARY IMAGING CATHETER BOSTON SCIENTIFIC CORP. ERIC ELLIOTT
K123561 11/19/2012 ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS BSN MEDICAL, INC. CARROLL D HOYLE
K123589 11/21/2012 CADWELL DISPOSABLE PROBE HANDLE CADWELL CHRIS BOLKAN
K123443 11/08/2012 PRECISE SHP DIODE LASER CAO GROUP, INC. ROBERT K LARSEN
K123571 11/26/2012 CARDIO VISION MICS AORTIC CLAMPS CARDIOMEDICAL GMBH ANGELIKA SCHERP
K123527 11/16/2012 AIRLIFE CAREFUSION ERIKA FERNANDEZ
K123464 11/09/2012 CALLISTO EYE CARL ZEISS MEDITEC AG JUDY BRIMACOMBE
K123433 11/07/2012 CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE CEDARS-SINAI MEDICAL CENTER GEOFF POLLARD, PROGRAM MANAGER
K123381 11/01/2012 HYPERION X9 CEFLA S.C. BERTHOIN CLAUDE
K123638 11/26/2012 PEKKTON IVORY CENDRES & METAUX SA T. BONGNI
K123436 11/07/2012 FIRST RESPONSE EARLY RESULT PREGNANCY TEST CHURCH & DWIGHT CO., INC. JOSEPH CICCONE
K123567 11/20/2012 FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST CHURCH & DWIGHT CO., INC. LISA BURNS
K123427 11/07/2012 NIRVANA D PERSONAL LUBRICANT (TBD) CHURCH & DWIGHT CO., INC. EMILY PEREZ
K123386 11/15/2012 PERIOTYPE X-PERT CLINICAL HOUSE EUROPE GMBH JUDI WEISSINGER
K123281 11/13/2012 ACCULIF TL-PEEK CAGE COALIGN INNOVATIONS, INC. JUSTIN EGGLETON
K123560 11/19/2012 VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM CODMAN & SHURTLEFF, INC. RICHARD KIMURA
K123650 11/27/2012 ARIX RAD ACQUISITION CONSOLE COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V. CARL ALLETTO
K123481 11/29/2012 AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE CONVATEC INC KATRINA FIEDLER
K123494 11/13/2012 SOLEA CONVERGENT DENTAL, INC CARRIE HETRICK
K123394 11/02/2012 CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING CORELEADER BIOTECH CO., LTD. VINCENT HUANG
K123083 11/05/2012 COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT COVIDIEN STACEY A STRAND
K123555 11/19/2012 KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY COVIDIEN JIM WELSH
K123318 11/05/2012 IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO HEALTHCARE SARAH RIZK
K123444 11/08/2012 LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE DAWN TINDALL
K123407 11/05/2012 CELLULAZE LASER CYNOSURE, INC. IRINA KULINETS
K123615 11/29/2012 IRIS - HIGH STRENGTH GLASS CERAMIC DENTSPLY INTL. HELEN LEWIS
K123668 11/29/2012 ORTHOCORD DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY TATYANA KORSUNSKY
K123362 11/01/2012 MILAGRO ADVANCE INTERFERENCE SCREW DEPUY MITEK, A JOHNSON & JOHNSON COMPANY YAYOI FUJIMAKI
K123647 11/27/2012 CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICE DEVON MEDICAL INC. RUTH WU
K123364 11/07/2012 25OH VITAMIN D TOTAL ELISA TEST DIASOURCE IMMUNOASSAYS, S.A. NAPOLEON MONCE
K123408 11/05/2012 ERGO IMAGING SYSTEM DIGIRAD CORP. MATTHEW OLOW
K123385 11/02/2012 MEDILAS H LASER FIBERS DORNIER MEDTECH AMERICA, INC. JOHN HOFFER
K123431 11/07/2012 DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D DREAMCON CO., LTD ALBERT REGO
K123370 11/01/2012 EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA EDWARDS LIFESCIENCES, LLC. KAREN JONES
K123366 11/19/2012 SURGITRON 4.0 DUAL RF S5-IEC ELLMAN INTERNATIONAL, INC. ALISON SATHE
K123538 11/16/2012 EPIEN ROOT CANAL CLEANSER EPIEN MEDICAL, INC. JEFFREY K SHAPIRO
K123660 11/28/2012 25-OH VITAMIN D ELISA EUROIMMUN US KATHRYN KOHL
K123544 11/19/2012 RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER EV3 INC LAURA J LIND
K123607 11/21/2012 OCTANE ELEVATE SPINAL IMPLANT SYSTEM EXACTECH, INC. PATRICK HUGHES
K123497 11/13/2012 FACET SCREW SYSTEM FACET-LINK, INC. JANICE M HOGAN
K123562 11/19/2012 FLOWER SMALL AND MEDIUM BONE IMPLANTS FLOWER ORTHOPEDICS CORPORATION JANICE M HOGAN
K123630 11/23/2012 FRESENIUS LIBERTY CYCLER FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE DENISE OPPERMANN
K123566 11/20/2012 SYNAPSE 3D COLON ANALYSIS FUJIFILM MEDICAL SYSTEMS U.S.A., INC. JYH-SHYAN LIN
K123430 11/14/2012 MICROSLIDER TEARAWAY INTRODUCER SET GALT MEDICAL CORP. DAVID DERRICK
K123631 11/27/2012 MFP-051 GC AMERICA, INC. MARK HEISS
K123417 11/06/2012 BRIVO MR355, OPTIMA MR360 GE HANGWEI MEDICAL SYSTEMS CO., LTD. RUOQIAN LIU
K123596 11/21/2012 OPTIMA CT520 GE HANGWEI MEDICAL SYSTEMS CO., LTD. HELEN PENG
K123564 11/20/2012 LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM GE HEALTHCARE BRYAN BEHN
K123522 11/15/2012 OPTIMA MR450W GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC) MICHELLE HUETTNER
K123603 11/21/2012 OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC GERALD BUSS
DEN120023 11/29/2012 GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM GIVEN IMAGING LTD. Tim Thomas
K123666 11/29/2012 GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM GIVEN IMAGING LTD. TIM THOMAS
K123487 11/13/2012 GSO GS1 CANNULATED SCREW SYSTEM GOLD STANDARD ORTHOPAEDICS, LLC DAVID BAUGHMAN
K123073 11/14/2012 DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0 GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED PATRICK CHOW
K123429 11/07/2012 OLYMPUS ENERGY POWER SYSTEM (EPS) GYRUS ACMI, INC. DOLAN MILLS
K123637 11/26/2012 HAMILTON-C3 HAMILTON MEDICAL AG RALPH AGUILA
K123076 11/19/2012 PROFTHAND MECHANICAL WHEELCHAIR HARMONY HILL INTERNATIONAL TINA LAI
K123410 11/05/2012 HEALTHY SLEEP APPLIANCE HEALTHY SLEEP DENTAL LABORATORY PAUL DRYDEN
K123077 11/08/2012 VASCULAR CLAMPS HEBU MEDICAL GMBH ANGELIKA SCHERP
K123587 11/21/2012 HEINE MINI 3000 LED OPHTHALMOSCOPE HEINE OPTOTECHNIK GMBH & CO. KG. JOERG ROENNAU
K123278 11/19/2012 IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF HERAEUS KULZER, LLC JAMIE MEARNA
K123641 11/26/2012 CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH HERTART HENRIK DORGE
K123627 11/23/2012 ET SMARTFIT ABUTMENT HIOSSEN INC. PATRICK LIM
K123471 11/13/2012 ETII SA FIXTURE SYSTEM HIOSSEN INC. PATRICK LIM
K123509 11/13/2012 SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K123530 11/26/2012 MAMMOGRAPHY PRIOR ENHANCEMENT (MPE) HOLOGIC, INC. GAIL YAEKER-DAUNIS
K123604 11/21/2012 ABG III MONOLITHIC HIP STEM HOWMEDICA OSTEONICS CORP COLLEEN BURDEL
K123442 11/08/2012 XOFT AXXENT CERVICAL APPLICATORS ICAD, INC. JOHN A DELUCIA
K123678 11/30/2012 HYALMIX CREAM IGI LABORATORIES, INC. FREDERICK WEISS
K123575 11/20/2012 MAMMOWORKSTATION IMAGE DIAGNOST INTERNATIONAL GMBH MOUNIR ZAOUALI
K123230 11/06/2012 MOSAIQ ONCOLOGY INFORMATION SYSTEM IMPAC MEDICAL SYSTEMS, INC. KATHRYN STINSON
K123672 11/29/2012 INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW) INION OY KATI MARTTINEN
K123682 11/30/2012 INMODE HAIR REMOVAL (HR) DEVICE INMODE MD LTD. AHAVA STEIN
K123551 11/19/2012 ITCLAMP 50 INNOVATIVE TRAUMA CARE INC RICHARD WAITE
K123593 11/21/2012 QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS, INOVA DIAGNOSTICS, INC. GABRIELLA LAKOS
K123111 11/05/2012 V8 TRANSLUMINAL BAV CATHETER INTERVALVE, INC JULIE BODMER
K123428 11/07/2012 MIROCAM CAPSULE ENDOSCOPE SYSTEM INTROMEDIC CO., LTD STEVE KWON
K123463 11/09/2012 INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS INTUITIVE SURGICAL, INC. CRYSTAL ONG
K123397 11/05/2012 MULTILINK AUTOMIX IVOCLAR VIVADENT AG SANDRA CAKEBREAD
K123662 11/28/2012 THE JUSTRIGHT SURGICAL VESSEL SEALING SYSTEM JUSTRIGHT SURGICAL, LLC MICHELE LUCEY
K123412 11/07/2012 RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS K2M, INC. NANCY GIEZEN
K123388 11/02/2012 K7C SPACER K7 LLC KARREN E WARDEN, PHD
K123402 11/05/2012 DIAGNOCAM KALTENBACH & VOIGT GMBH STEFAN TRAMPLER
K123507 11/13/2012 KCI NPWT GAUZE DRESSING KCI USA, INC. ANONA GOEBEL
K123468 11/09/2012 DEMI ULTRA KERR CORPORATION WENDY GARMAN
K123595 11/21/2012 NEXUS RMGI KERR CORPORATION COLLEEN BOSWELL
K123499 11/13/2012 AEROPILOT KONICA MINOLTA MEDICAL & GRAPHIC, INC. RUSSELL MUNVES
K123665 11/28/2012 LIFELINES IEEG KVIKNA EHF YOLANDA SMITH
K123219 11/19/2012 URGOCLEAN ABSORBENT WOUND DRESSING LABORATOIRES URGO SOPHIE FORTIN
K123177 11/28/2012 STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM LASERSTIM, INC. DAVID C FURR
K123134 11/05/2012 EASYSPINE SYSTEM LDR SPINE USA INC. MARITZA ELIAS
K123531 11/16/2012 UNBALLOON NON-OCCLUSIVE MODELING CATHETER LEMAITRE VASCULAR, INC. BRYAN COWELL, RAC
K123473 11/13/2012 HOPER PTCA BALLOON CATHETER LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD ARTHUR GODDARD
K123475 11/13/2012 SHOOCIN INTRODUCER KIT LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD ARTHUR GODDARD
K123373 11/01/2012 NAUTILUS SPINAL SYSTEM LIFE SPINE RANDY LEWIS
K123369 11/01/2012 ILUMIEN OPTIS LIGHTLAB IMAGING, INC. JEFFREY ROBERTS
K123600 11/21/2012 DIGITAL BLOOD PRESSURE MONITOR LITTLE DOCTOR ELECTRONIC (NANTONG) CO., LTD. SELINA QIAN
K123476 11/13/2012 MEGA 5.5 SPINE SYSTEM LSK BIOPARTNERS, INC. SHIN KUK YOO
K123629 11/23/2012 FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVES LUCENXIA PRESCIENCE AG ROBERT HILL
K123628 11/23/2012 STERILE LATEX SURGICAL GLOVE LUCENXIA PRESCIENCE AG ROBERT HILL
K123466 11/09/2012 HEALTHVIEW ECG MANAGER LUMEDX CHRIS PEARCE
K123563 11/28/2012 LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM MAGELLAN DIAGNOSTICS STUART NAYLOR
K123127 11/05/2012 VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 MAINE STANDARDS CO. JAMES W CHAMPLIN
K123149 11/05/2012 SERVO-I VENTILATOR SYSTEM MAQUET CRITICAL CARE AB WHITNEY TORNING
K123676 11/30/2012 CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES MAUNA KEA TECHNOLOGIES MICHAEL DANIEL
K123586 11/21/2012 EASYRA CREATININE REAGENT MEDICA CORPORATION PHOTIOS MAKRIS
K123617 11/27/2012 3F PRO-PICC MEDICAL COMPONENTS INC JESSICA LEO
K123138 11/08/2012 PASS LP SPINAL SYSTEM MEDICREA INTERNATIONAL LAURE AVIRON-VIOLET
K123591 11/21/2012 FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) MEDTRONIC CRYOCATH LP VANESSA WARE
K123524 11/15/2012 MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM MEDTRONIC NEUROSURGERY DONOVAN MAY
K123568 11/20/2012 VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. MIKE SCOTT
K123656 11/28/2012 VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. CLAIRE EVANS
K123619 11/23/2012 INTRABLOCK BIOBALL HIP SYSTEM (IBS) MERETE MEDICAL GMBH EMMANUEL ANAPLIOTIS
K123423 11/06/2012 ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT MERIDIAN BIOSCIENCE, INC. MICHELLE L SMITH
K123609 11/21/2012 MERIT HYDROPHILIC GUIDE WIRE MERIT MEDICAL SYSTEMS, INC. STEPHANIE ERSKINE
K123363 11/01/2012 SUPER STAPLE(TM) CLASSIC METRIC MEDICAL DEVICES, INC. W CASEY FOX PHD PE
K123378 11/01/2012 SOLITAIRE 2 REVASCULARIZATION DEVICE MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR LARRY BOUCHER
K123384 11/02/2012 AZUR CX DETACHABLE 18 MICROVENTION, INC. CYNTHIA VALENZUELA
K123624 11/23/2012 OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM MIMOSA ACOUSTICS, INC. PATRICIA S JENG
K123556 11/19/2012 MORTARA SURVEYOR PATIENT MONITOR MORTARA INSTRUMENT, INC. AMY YANG
K123516 11/14/2012 CRYO-TOUCH IV MYOSCIENCE INC TRACEY HENRY
K123445 11/08/2012 NMI COAXIAL MICROINTRODUCER SET NAVILYST MEDICAL, INC. WANDA CARPINELLA
K123439 11/08/2012 NEO ERCP GUIDEWIRE NEOMETRICS, INC. GENE CHAMPEAU
K123554 11/19/2012 SHUNTCHECK NEURODX DEVELOPMENT LLC FREDERICK J FRITZ
K123642 11/26/2012 MUSCLE STIMULATION SYSTEM NIVEUS MEDICAL, INC. CINDY DOMECUS, R.A.C. (US & EU)
K123347 11/07/2012 NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0 NORMED MEDIZIN-TECHNIK GMBH DAVID C FURR
K123395 11/05/2012 NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS NXSTAGE MEDICAL, INC. MARY LOU STROUMBOS
K123421 11/06/2012 OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM OLYMPUS MEDICAL SYSTEMS CORP. DAPHNEY GERMAIN-KOLAWOLE
K123601 11/21/2012 SINGLE USE REPOSITIONABLE CLIP OLYMPUS MEDICAL SYSTEMS CORP. SHERI L MUSGNUNG
K123498 11/13/2012 BP652N (HEM-6300-Z) OMRON HEALTHCARE, INC. PAUL DRYDEN
K123118 11/09/2012 INSIGNIA DIGICAST ORMCO CORP. WENDY GARMAN
K123416 11/06/2012 INSIGNIA WITH ITERO ORMCO CORP. WENDY GARMAN
K123426 11/07/2012 MEDICVOD, MEDICAST, MEDISHOW, MEDISEARCH, CENTRAL STORAGE SYSTEM - CSS ORPHEUS MEDICAL, LTD. CLAY ANSELMO
K123457 11/13/2012 BALANCED KNEE SYSTEM HIGH FLEX PS ORTHO DEVELOPMENT CORP. TOM HAUETER
K123243 11/20/2012 HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY ORTHOCON, INC. HOWARD SCHRAYER
K123470 11/13/2012 PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE PAS SYSTEMS INTERNATIONAL, INC. JAREL R KELSEY
K123576 11/20/2012 IMR SOFTWARE APPLICATION PHILIPS HEALTHCARE (CLEVELAND) CHRISTINE ANDERSON
K123599 11/21/2012 INGENUITY DIGITAL PET/CT PHILIPS HEALTHCARE (CLEVELAND) MICHAEL S PRETO
K123492 11/13/2012 DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L) PHILIPS MEDICAL SYSTEMS LISA SIMPSON
K123450 11/13/2012 PHONAK TINNITUS BALANCE PHONAK LLC LAURA ELLMAN
K123565 11/20/2012 PRESTO 1000 SYSTEM PHYSIOSONICS, INC DAVID CRONISER
K123651 11/27/2012 CINCHLOCK KNOTLESS SUTURE ANCHOR PIVOT MEDICAL JON COOK
K123399 11/05/2012 MYOVISION 3.0 WIREFREE SYSTEM PRECISION BIOMETRICS, INC. ERIC CHEN
K123488 11/13/2012 LINSHI NITRILE DISPOSABLE EXAM GLOVES, POWDER-FREE PUYANG LINSHI HEALTH CO., LTD LAURA WENG
K123514 11/14/2012 CLEARPATH ALIGNER QSERVE AMERICA, INC. PATSY TRISLER
K123573 11/20/2012 YOULASER CO2 LASER QUANTA SYSTEM, S.P.A. MAURIZIO BIANCHI
K123355 11/06/2012 AMPLIVUE C. DIFFICILE ASSAY QUIDEL CORPORATION RONALD H LOLLAR
K123345 11/21/2012 DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA RAYENCE CO., LTD DAVE KIM
K123521 11/19/2012 RELIANCE SPINAL SCREW SYSTEM RELIANCE MEDICAL SYSTEMS, LLC BRET M BERRY
K123348 11/01/2012 CLEAR ALIGNER ADHESIVE RELIANCE ORTHODONTIC PRODUCTS, INC. PAULA WENDLAND
K123398 11/05/2012 DR. SCHOLL'S COMPRESSION SOCKS RENFRO CORPORATION REBECCA K PINE
K123557 11/19/2012 EASYCARE ONLINE RESMED LTD. JIM CASSI
K123511 11/28/2012 S9 VPAP TX RESMED LTD. JIM CASSI
K123548 11/19/2012 THE ARTAS SYSTEM RESTORATION ROBOTICS, INC JIM TALBOT
K123526 11/15/2012 CLEARREAD +CONFIRM RIVERAIN TECHNOLOGIES JENNIFER BUTSCH
K123582 11/20/2012 ENDO A CLASS SAEYANG MICROTECH CO., LTD JIGAR SHAH
K123608 11/21/2012 ENDO E CLASS SAEYANG MICROTECH CO., LTD JIGAR SHAH
K123226 11/19/2012 LESSRAY SAFERAY SPINE, LLC CALLEY HERZOG
K123671 11/29/2012 WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM SANITAS, INC. ALAN DONALD
K123606 11/21/2012 CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE SCION MEDICAL TECHNOLOGIES LLC JOSEPH OSTENDORF
K123517 11/14/2012 GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEM SD BIOSENSOR JIGAR SHAH
K123477 11/13/2012 VIA MICROCATHETER, VIA PLUS MICROCATHETER SEQUENT MEDICAL, INC MELANIE PARRAVI
K123503 11/13/2012 DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD BAI YANHONG
K123155 11/13/2012 LUNA DENTAL IMPLANT SYSTEM SHINHUNG MST CO., LTD SUNBYUNG LEE
K123375 11/01/2012 SYNGO.VIA SIEMENS AG SABINE SCHROEDEL
K123677 11/30/2012 DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) SIEMENS HEALTHCARE DIAGNOSTICS ROSE T MARINELLI
K123622 11/23/2012 ACUSON SIEMENS MEDICAL SOLUTIONS USA INC. PATRICK LYNCH
K123529 11/16/2012 ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. PATRICIA D JONES
K123510 11/13/2012 MAGNETOM SKYRA SIEMENS MEDICAL SOLUTIONS USA, INC. NADIA SOOKDEO
K123520 11/15/2012 MAMMOMAT INSPIRATION PRIME SIEMENS MEDICAL SOLUTIONS USA, INC. PATRICIA D JONES
K123528 11/16/2012 SCENIUM SIEMENS MEDICAL SOLUTIONS USA, INC. ELAINE CHANG
K123420 11/06/2012 SYNGO, BREAST CARE SIEMENS MEDICAL SOLUTIONS USA, INC. PATRICIA D JONES
K123584 11/21/2012 SYNGO, CT BONE READING SIEMENS MEDICAL SOLUTIONS USA, INC. KIMBERLY MANGUM
K123585 11/21/2012 SYNGO, CT CARDIAC FUNCTION SIEMENS MEDICAL SOLUTIONS USA, INC. KIMBERLY MANGUM
K123577 11/20/2012 SYNGO.VIA MI WORKFLOWS SIEMENS MEDICAL SOLUTIONS USA, INC. ALAINE MEDIO, RAC
K123540 11/19/2012 SYNGO CT PULMO 3D SIEMENS MEDICAL SYSTEMS, INC. KIMBERLY MANGUM
K123541 11/19/2012 SYNGO.CT NEURO PERFUSION SIEMENS MEDICAL SYSTEMS, INC. KIMBERLY MANGUM
K123070 11/05/2012 GALILEOS FAMILY SIRONA DENTAL SYSTEMS GMBH FRITZ KOLLE
K123545 11/21/2012 INCORIS TZI SIRONA DENTAL SYSTEMS GMBH FRITZ KOLLE
K123664 11/28/2012 INCORIS ZI SIRONA DENTAL SYSTEMS GMBH FRITZ KOLLE
K123579 11/29/2012 FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL SMITH & NEPHEW, INC. CATHERINE KILSHAW
K123393 11/06/2012 HEALICOIL SUTURE ANCHOR WITH REGENESORB SMITH & NEPHEW, INC. SUE DAHLQUIST
K123055 11/02/2012 SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION SMITH & NEPHEW, INC. BRADLEY HEIL
K123598 11/28/2012 SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION SMITH & NEPHEW, INC. BRADLEY HEIL
K123425 11/26/2012 TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL SMITH & NEPHEW, INC. CATHERINE KILSHAW
K123479 11/19/2012 PROGRIP LAPAROSCOPIC SELF-FIXATING MESH SOFRADIM PRODUCTION JAMES MCMAHON
K123684 11/30/2012 SOL-CARE SAFETY NEEDLE SOL-MILLENNIUM MEDICAL JIM BARLEY
K123616 11/23/2012 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM SONOSCAPE COMPANY LIMITED DIANA HONG
K123632 11/23/2012 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035 SPECTRANETICS CORP. CHRISTINE GODLESKI
K123461 11/09/2012 STAXX(R) IB SYSTEM SPINE WAVE, INC. ROAIDA RIZKALLAH
K123652 11/27/2012 SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE SPINEOLOGY, INC. BRYAN BECKER
K123484 11/20/2012 SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC) CONTACT LENS ST. SHINE OPTICAL CO., LTD. ELLA LEE
K123539 11/16/2012 STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK STAYHEALTHY, INC. COLIN HILL PHD.
K123478 11/13/2012 STINGRAY BIPOLAR FORCEPS STINGRAY SURGICAL PRODUCTS MARK MCBRINN
K123452 11/08/2012 TRACKER-17 MICROCATHER, 150 CM LONG AND 15.0 CM FLEXIBLE DISTAL SHAFT, TRACKER-17 MICROCATHETER, 150 CM LONG AND 7.5 CM STRYKER JEAN CHEN
K123486 11/13/2012 TRIATHLON TRITANIUM TIBIAL BASEPLATE STRYKER AUDREY WITKO
K123441 11/08/2012 STRYKER CROSSFLOW ARTHROSCOPY PUMP STRYKER ENDOSCOPY KEVIN POTGIETER
K123377 11/01/2012 TARGET DETACHABLE COIL STRYKER NEUROVASCULAR RHODA SANTOS
K123403 11/28/2012 AXSOS PROXIMAL LATERAL TIBIA LONG PLATES STRYKER TRAUMA AG ESTELA CELI
K123401 11/28/2012 GAMMA3 AND T2 RECON TARGETING DEVICES STRYKER TRAUMA AG ESTELA CELI
K123409 11/05/2012 QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN SURGICAL SPECIALTIES CORP. DBA ANGIOTECH KIRSTEN STOWELL
K123646 11/27/2012 EMORY CARDIAC TOOLBOX 4.0 SYNTERMED, INC. KENNETH VAN TRAIN
K123640 11/26/2012 TX1 TISSUE REMOVAL SYSTEM TENEX HEALTH DAVID SALZBERG
K123446 11/08/2012 TL-300 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM TENSYS MEDICAL SYSTEMS, INC JAMIE SULLEY
K123472 11/13/2012 CIMVA UNIVERSAL THERAPEUTIC MONITORING SYSTEMS (TMS), INC. CRAIG J COOMBS
K123396 11/05/2012 I.FLEX BY TCS THERMOPLASTIC COMFORT SYSTEMS, INC. MARLIN POSCA
K123633 11/23/2012 TRS CRANIAL BONE VOID FILLER(TRS C-BVF) TISSUE REGENERATION SYSTEMS, INC. JIM FITZSIMMONS
K123542 11/19/2012 PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER TOPCON MEDICAL LASER SYSTEMS, INC PAMELA M BUCKMAN
K123460 11/09/2012 TRC-NW300 NON-MYDRIATIC RETINAL CAMERA TOPCON MEDICAL SYSTEMS, INC. MICHAEL GUSEL
K123500 11/13/2012 AQUILION LB TRITON V4.91 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K123525 11/15/2012 GRIDLOCK PLATING SYSTEM TRILLIANT SURGICAL LTD J.D. WEBB
K123400 11/05/2012 AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE TRUDELL MEDICAL INTL. DARRYL FISCHER
K123614 11/26/2012 SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) TRUDELL MEDICAL INTL. DARRYL FISCHER
K123087 11/02/2012 TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM TYSON BIORESEARCH, INC. WEN-HAI TSAI
K123215 11/07/2012 VISCOSTAT CLEAR ULTRADENT PRODUCTS, INC. KAREN KAKUNES
K123493 11/15/2012 VEX-S 100W INTRAORAL X-RAY SYSTEM VATECH CO., LTD. DAVE KIM
K123220 11/14/2012 VERTEX THERMOSENS RIGID VERTEX-DENTAL B.V. MASON DIAMOND
K123371 11/01/2012 ALIGNRT PLUS VISION RT LIMITED NORMAN SMITH
K123467 11/14/2012 VS3 VISIONSENSE, LTD. GERARD J PRUD'HOMME
K123644 11/28/2012 VIZION + DR VIZTEK LLC DANIEL KAMM, P.E.
K123156 11/13/2012 GORE FLOW REVERSAL SYSTEM MODEL GFRS073 W. L. GORE & ASSOCIATES, INC. SHARON ALEXANDER
K123469 11/13/2012 POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE WEAR SAFE (MALAYSIA) SDN BHD - FACILITY II ALEX YOONG
K123578 11/20/2012 ANTERIOR CERVICAL PLATE SYSTEM WEIGAO ORTHOPAEDIC DEVICE CO., LTD DIANA HONG
K123590 11/21/2012 VINYL EXAMINATION POWDER FREE GLOVES, CLEAR WEILIN PLASTIC AND RUBBER PRODUCTS CO., LTD. LING ZHU
K123588 11/21/2012 INTRADERMAL ADAPTER WEST PHARMACEUTICAL SERVICES, INC. DEBBIE M THOMAS
K123680 11/30/2012 COPRANCOLOR WHITE PEAKS DENTAL SYSTEMS GMBH & CO. KG OLIVER PUCKERT
K123681 11/30/2012 1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL WIPRO GE HEALTHCARE PRIVATE, LTD. SHASHIDHAR C S
K123116 11/13/2012 CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR) WORLDMED MANUFACTURING SDN. BHD. OOI LOON SENG
K123434 11/07/2012 PROFEMUR Z CLASSIC STEMS WRIGHT MEDICAL TECHNOLOGY, INC. DAVID FITCH
K123438 11/08/2012 XENX STONE MANAGEMENT DEVICE XENOLITH MEDICAL OFER ZIGMAN
K123387 11/02/2012 QUIKCLOT HEMOSTATIC DRESSING Z-MEDICA, LLC SHEILA WALLIN
K123658 11/28/2012 BIOMODULE 3-M1 ZEPHYR TECHNOLOGY CORPORATION RICHARD KEEN
K123669 11/29/2012 TRANSTEK WRIST BLOOD PRESSURE MONITOR ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. LEO WANG
K123392 11/02/2012 AVENIR MULLER STEM ZIMMER GMBH KAREN O'LEARY
K123553 11/19/2012 ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM ZIMMER INC. ALLISON SCOTT, RAC
K123459 11/14/2012 ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM ZIMMER INC. CAROL VIERLING, RAC
K123552 11/19/2012 INSTINCT JAVA SYSTEM ZIMMER SPINE ELSA A LINKE
K123602 11/21/2012 TM ARDIS INTERBODY SYSTEM INSERTER ZIMMER TRABECULAR METAL TECHNOLOGY JUDITH ROSEN


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