FDA 510(k) Applications Received During December, 2012

FDA 510(k) Number Submission Date Device Name Applicant Contact
K123733 12/05/2012 CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM MEDTRONIC INC. KARI CHRISTIANSON
K123762 12/07/2012 DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF MEDTRONIC INC. CHELSEA PIOSKE
K123875 12/17/2012 AAP RADIUS SET 2.5 AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K123888 12/18/2012 Z CARTRIDGE IOL DELIVERY SYSTEM AAREN SCIENTIFIC, INC ROBERT K SHEEHAN
K123372 12/04/2012 ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR ABBOTT LABORATORIES LINDA MORRIS
K123951 12/21/2012 VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION) ABBOTT MOLECULAR, INC. NANCY W BENGTSON
K123890 12/18/2012 ACUMED CANNULATED SCREW SYSTEM ACUMED LLC KARA BUDOR
K123936 12/27/2012 SURGISEAL TOPICAL SKIN ADHESIVE ADHEZION BIOMEDICAL, LLC CARIDAD SMITH
K123909 12/19/2012 AESCULAP CESPACE XP AESCULAP IMPLANT SYSTEM, INC. LISA M BOYLE
K123939 12/20/2012 S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS, INC. LISA M BOYLE
K123882 12/17/2012 AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR AGELESS HEALTH INDUSTRIAL VICTOR WAN
K123986 12/26/2012 ACTIM PROM ALERE SCARBOROUGH, INC ANGELA DRYSDALE
K123953 12/21/2012 ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. HYMAN KATZ PH.D.
K123796 12/10/2012 NEURO OMEGA SYSTEM ALPHA OMEGA ENGINEERING LTD. ILAN SHARON
K123993 12/26/2012 SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM ALPHATEC SPINE, INC. TREVOR DENBO
K123943 12/20/2012 AMECATH DUAL LUMEN HEMODIALYSIS CATHETER AMECO MEDICAL INDUSTRIES RAY KELLY
K123746 12/14/2012 AMES THERAPY DEVICE AMES TECHNOLOGY, INC. SHEILA RAMERMAN, RAC
K123935 12/20/2012 IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM ANDON MEDICAL CO., LTD. YI LIU
K123699 12/03/2012 FAHL TRACHEOSTOMY TUBES (MULTIPLE) ANDREAS FAHL MEDIZINTECHNIK-VERTRIEB GMBH CLAUDIA WINTERSCHLADEN
K123823 12/12/2012 INTERLIG ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS LILIAN LLULL
K124027 12/28/2012 MONSTER SCREW SYSTEM APOGEE ORTHOSOLUTIONS KAREN E WARDEN, PHD
K123716 12/04/2012 AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT APPLIED MEDICAL TECHNOLOGY, INC. GRANT W PHILLIPS
K123759 12/07/2012 CG+ ARROW PICC POWERED BY ARROW VPS STYLET ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) ELIZABETH DUNCAN
K123760 12/07/2012 MULTIPLE NAME ASSURGUARD SDN. BHD. LIM HUI GUAN
K123757 12/07/2012 POWDER FREE LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM, NATURAL COLOR ASSURGUARD SDN. BHD. LIM H GUAN
K123937 12/20/2012 ATOM TRANSCAPSULE V-707 ATOM MEDICAL CORPORATION PAUL DRYDEN
K123921 12/20/2012 BODYTRONIC 200 BAUERFEIND AG INES EXNER
K123736 12/10/2012 CRYSTALSERT DELIVERY SYSTEM BAUSCH & LOMB JASON SMITH
K123874 12/17/2012 INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S BAXTER HEALTHCARE CORP. NANETTE HEDDEN
K123868 12/17/2012 INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET BAXTER HEALTHCARE CORP. GARY CHUMBIMUNE
K123903 12/19/2012 BD BACTEC LYTIC/10 ANAEROBIC/F (PLASTIC) BECTON DICKINSON & CO. PAUL SWIFT
K123734 12/05/2012 BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. KIMBERLY GEISLER
K124038 12/28/2012 BEDSIDE PAEDIATRIC EARLY WARNING SYSTEM (BEDSIDEPEWS) BEDSIDE CLINICAL SYSTEMS INC DIANE SUDDUTH
K123929 12/20/2012 BEGOPAL+ BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO HEIKE GUSTKE
K123871 12/17/2012 FINGERTIP PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. LEI CHEN
K123896 12/18/2012 CCS-200 SPIROMETER BENSON MEDICAL INSTRUMENTS CO. DAVID MAYOU
K123710 12/18/2012 UNITOX BOTOX SYRINGE BIO-MED USA INC YOUNG CHI
K123775 12/10/2012 LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK BIO-RAD LABORATORIES SUZANNE PARSONS
K123798 12/10/2012 LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK BIO-RAD LABORATORIES SUZANNE PARSONS
K123947 12/21/2012 ARCHITECT IVANCOMYCIN BIOKIT S.A. GUILLEM ANGLERILL
K123745 12/06/2012 SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL BIOMECANICA INDUSTRIA E COMERICO DE PRODUCTOS ORTOPEDICOS LT TARA CONRAD
K124022 12/28/2012 SPEED SHIFT BIOMEDICAL ENTERPRISES, INC JOE SOWARD
K123907 12/19/2012 PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS, BIOMET MANUFACTURING CORP. ELIZABETH WRAY
K123966 12/26/2012 GLUCOSE METER-CHECK SOLUTION FOR BAYER BIONOSTICS, INC. RANDY BYRD
K123851 12/17/2012 GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK BIONOSTICS, INC. RANDY BYRD
K123961 12/26/2012 SENTREX BIOSPONGE MPD BIONOVA MEDICAL, INC ALEX GREENE
K123821 12/12/2012 AIO HD OTOSCOPE BLUE FOCUS KI CHEOL HAN
K123820 12/12/2012 BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS BOSSONG HOSIERY MILLS, INC ROGER RAND
K123765 12/07/2012 GUIDEZILLA GUIDE EXTENSION CATHETER BOSTON SCIENTIFIC HOLLY RAMIREZ
K123718 12/04/2012 PERMASORB DISPOSABLE FIXATION DEVICE C.R. BARD INC RADHIKA PONDICHERRY
K123911 12/19/2012 SENOMARK ULTRA BREAST TISSUE MARKER C.R. BARD, INC. SARAH MCCARTNEY
K123810 12/11/2012 PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM CARBOFIX ORTHOPEDICS LTD. YAEL RUBIN
K123857 12/14/2012 DURABLUE STERILIZATION WRAP CARDINAL HEALTH 200, LLC LAVENIA FORD
K124053 12/31/2012 NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) CARTICEPT MEDICAL, INC. TANYA EBERLE
K123700 12/03/2012 FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K123967 12/26/2012 CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS CATHETER CONNECTIONS, INC. DONALD D SOLOMON
K123905 12/19/2012 CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION HYE-JOO KIM, PHARM. D
K123844 12/13/2012 CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST CHEMTRON BIOTECH, INC. JANE ZHANG
K123994 12/26/2012 DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL CIBA VISION CORPORATION MARTINA HEIM, PH.D., RAC
K123946 12/21/2012 WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS CINCINNATI SUB-ZERO PRODUCTS, INC STEVEN J BERKE
K123752 12/06/2012 ACCULIF TL AND PL CAGE COALIGN INNOVATIONS, INC. JUSTIN EGGLETON
K123675 12/04/2012 RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR COLOPLAST A/S BRIAN SCHMIDT
K123914 12/19/2012 RESTORELLE Y CONTOUR COLOPLAST A/S TIM CRABTREE
K124030 12/28/2012 COOK HOLMIUM LASER FIBER COOK INCORPORATED CONNIE RICE
K123712 12/04/2012 RETRACTA DETACHABLE EMBOLIZATION COIL COOK INCORPORATED JENNIFER RICHARDSON
K123707 12/03/2012 ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE COOK, INC. DAVID LEHR
K123705 12/03/2012 TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS CORIN USA DIANA L MARTONE
K123756 12/07/2012 COVAGEN COVALON TECHNOLOGIES LTD. CHRISTOPHER FREDRIC
K123581 12/10/2012 NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC. MIA M WARE
K123893 12/18/2012 CURA COLLIMATOR CURA MEDICAL TECHNOLOGIES, LLC THOMAS H FARIS
K123897 12/18/2012 K SERIES CPAP SYSTEMS CURATIVE MEDICAL INC. AMY MCKINNEY
K123818 12/12/2012 URSA ANGIOGRAPHIC CATHETER CURATIVE MEDICAL TECHNOLOGY, INC. AMY MCKINNEY
K123971 12/26/2012 CYNOSURE 1064NM DIODE LASER CYNOSURE, INC. IRINA KULINETS
K123830 12/12/2012 INTERMITTENT PNEUMATIC COMPRESSION DEVICE DALIAN LABTEK SCIENCE & DEVELOPMENT CO., LTD. DORIS DONG
K123869 12/17/2012 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES DEHAI (SHANDONG) MEDICAL GLOVES, CO., LTD RAY ZHOU
K124018 12/27/2012 AMIA AUTOMATED PD SYSTEM DEKA RESEARCH & DEVELOPMENT CORP. ROGER A LEROUX
K123940 12/20/2012 DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE DEMETECH CORP. JOHN O'BRIEN
K124025 12/28/2012 ALPHA-PRO WHITE VARNISH DENTAL TECHNOLOGIES, INC. PAULA ERICKSON
K123849 12/14/2012 NEW COMFORT-FIT DENTAL GUARD DENTEK ORAL CARE, INC. LINDA GILES
K123925 12/20/2012 MTM CLEAR ALIGNER IN-OFFICE DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K123991 12/26/2012 DEPUY CORAIL AMT HIP PROSTHESIS DEPUY FRANCE S.A.S. ALMA RELJA, RAC
K123924 12/20/2012 DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS DEPUY ORTHOPAEDICS CORRENE RAMY
K123959 12/21/2012 CIRCUFLOW 5150 DEVON MEDICAL INC. RUTH WU
K123824 12/12/2012 VITRO FIL LC DFL INDUSTRIA E COMERCIO S.A. TARA CONRAD
K123826 12/12/2012 VITRO MOLAR DFL INDUSTRIA E COMERCIO S.A. TARA CONRAD
K124009 12/27/2012 MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C DIAMOND DIAGNOSTICS, INC. KATHY CRUZ
K123969 12/26/2012 XIPHOS DIFUSION TECHNOLOGIES KAREN E WARDEN, PHD
K124016 12/27/2012 EMPI PHOENIX DJO, LLC KEN FISHER
K123776 12/10/2012 POLARIS 100/200 DRAGER MEDICAL GMBH BETH ZIS
K123806 12/10/2012 FIBROSCAN ECHOSENS ZVI LADIN, PH.D.
K123263 12/05/2012 HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS ECKERT & ZIEGLER BEBIG GMBH HUB VAN DE BERGH
K123714 12/04/2012 EDWARDS EMBOL-X INTRODUCER SHEATH EDWARDS LIFESCIENCES, LLC. LUKE MEIDELL
K123808 12/11/2012 AGILITY ELEKTA LTD. PATRICK HULL
K123729 12/05/2012 VERSARATE FLOW RATE CONTROLER EMED TECHNOLOGIES CORPORATION PETER KOLLINGS
K123982 12/26/2012 TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+ ENCORE MEDICAL, L.P. MICHAELA NORRIS
K123696 12/03/2012 MEDUSA VASCULAR PLUG ENDOSHAPE, INC. MICHAEL PARMENTER
K124055 12/31/2012 T1040 AKA AURAWAVE ENDURANCE THERAPEUTICS BRAD BREZDEN
K123740 12/05/2012 EOS EOS IMAGING JOHN J SMITH
K124064 12/31/2012 YOUNG AGAIN ESPANSIONE MARKETING SPA GUIDO BONAPACE
K123853 12/31/2012 VIVASIGHT-DL SYSTEM ETVIEW LTD. YORAM LEVY
K123687 12/03/2012 OPTETRAK LOGIC POROUS FEMORAL COMPONENT EXACTECH, INC. PATRICK HUGHES
K123831 12/12/2012 OPHTACATH KIT FRANCE CHIRURGAE INSTRUMENTATION BARBARA S FANT
K124035 12/28/2012 2008K@HOME HEMODIALYSIS MACHINE FRESENIUS MEDICAL CARE NORTH AMERICA DENISE OPPERMANN
K124024 12/28/2012 APD LUER-LOCK ADAPTER FRESENSIUS MEDICAL CARE NORTH AMERICA DENISE OPPERMANN
K123701 12/03/2012 HEARLAB ACA FRYE ELECTRONICS, INC. KRISTINA FRYE
K123612 12/20/2012 FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA FUJIREBIO DIAGNOSTICS, INC. KENT PRUETT
K123814 12/14/2012 HUMELOCK II CEMENTED SHOULDER SYSTEM FX SOLUTIONS JEAN-JACQUES MARTIN
K123865 12/17/2012 VISUAL-ICE CRYOABLATION SYSTEM GALIL MEDICAL INC. AMY MCKINNEY
K123996 12/26/2012 RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. MARY CARTER
K123894 12/18/2012 GE ECHOPAC GE VINGMED ULTRASOUND AS BRYAN BEHN
K123838 12/17/2012 PRO HMPV+ ASSAY GEN-PROBE PRODESSE, INC. KAREN HARRINGTON
K123731 12/10/2012 BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH) PAUL KRUMM
K123782 12/10/2012 PARAGON HIP SYSTEM GLOBAL MANUFACTURING TECHNOLOGY HOLLACE S RHODES
K124058 12/31/2012 CREO STABILIZATION SYSTEM GLOBUS MEDICAL INC. SARAH M FITZGERALD
K123913 12/19/2012 LATIS SPACER GLOBUS MEDICAL INC. CHRISTINA KICHULA
K123783 12/10/2012 ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS GLOBUS MEDICAL, INC. SARAH M FITZGERALD
K123915 12/19/2012 DE48-PLUS GRASS TECHNOLOGIES, AN ASTRO-MED, INC. PRODUCT GRO PHILLIP SOARES
K123368 12/13/2012 LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT HARTALEGA SDN BHD NURUL AISYAH KONG
K123703 12/03/2012 HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE) HEALGEN SCIENTIFIC, LLC BRYAN FANG
K123881 12/17/2012 HEARTSINE SAMARITAN PAD 350P HEARTSINE TECHNOLOGIES, INC. JAMES MCGUINNESS
K124039 12/28/2012 HERO GRAFT HEMOSHPERE, INC., A CRYOLIFE COMPANY LAURIE LYNCH
K124032 12/28/2012 METANEB HILL-ROM SERVICES PTE LTD PAUL DRYDEN
K123828 12/12/2012 PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM HITACHI ALOKA MEDICAL, LTD. ANGELA VAN ARSDALE
K123804 12/10/2012 INSTAFLO BOWEL CATHETER SYSTEM KIT HOLLISTER, INC. CHRIS STUKEL
K123873 12/18/2012 CONTRAST ENHANCED DIGITAL MAMMOGRAPHY HOLOGIC, INC. DEBORAH THOMAS
K123724 12/04/2012 DERMISEB CREAM IGI LABORATORIES, INC. FREDERICK WEISS
K124006 12/26/2012 ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY ILLUMINA, INC. LEANNE M KIVIHARJU
K123989 12/26/2012 ILLUMINA MISEQDX PLATFORM ILLUMINA, INC. LEANNE M KIVIHARJU
K123713 12/04/2012 IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA IMMCO DIAGNOSTICS, INC. KEVIN J LAWSON
K123763 12/07/2012 IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS IMMUNODIAGNOSTIC SYSTEMS LTD. MICK FENTON
K123860 12/14/2012 INMODE SR IPL DEVICE INMODE MD LTD. AHAVA STEIN
K123761 12/12/2012 VITA ENAMIC STAINS INNOVATION MEDITECH GMBH ELIZABETH WOLFSEN
K123987 12/26/2012 IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET INNOVATIVE MEDICAL TECHNOLOGIES, INC. BRAD BROWN
K123972 12/26/2012 WALKAIDE SYSTEM INNOVATIVE NEUROTRONICS INC. GLEN NEALLY
K123880 12/17/2012 QUANTA FLASH CENTROMERE INOVA DIAGNOSTICS, INC. ANDREA SEAMAN
K123753 12/06/2012 IMDX VANR FOR ABBOTT M2000 INTELLIGENT MEDICAL DEVICES, INC FRAN WHITE
K124048 12/31/2012 IMAGEQUBE INTUITIVE IMAGING INFORMATICS, LLC CINDY SIMONI
K123840 12/17/2012 CONNECT FOR DA VINCI SURGICAL SYSTEM(S) INTUITIVE SURGICAL, INC. CHERECE L JONES
K124031 12/28/2012 DA VINCI FLUORESCENCE IMAGING VISION SYSTEM INTUITIVE SURGICAL, INC. CINDY DOMECUS
K124061 12/31/2012 MRI PATIENT MONITORING SYSTEM (MODEL 865214) INVIVO CORPORATION RUSTY KELLY
K123158 12/20/2012 ION MAGNUM GENIUS ION GENIUS INC XANYA SOFRA-WEISS
K124008 12/31/2012 IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE IVOCLAR VIVADENT, AGIN DONNA MARIE HARTNETT
K124014 12/27/2012 SUREFIX INTERSPINOUS FUSION SYSTEM JG SPINE, LLC JOHN KAPITAN
K123787 12/10/2012 GREENCROSS SURGICAL MASK JINGZHOU HAIXIN GREEN CROSS MEDICAL PRODUCTS CO.,LTD XIANGYANG SONG
K124037 12/28/2012 JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE JUNG RIM MEDICAL INDUSTRIAL CO., LTD KYU LEE
K123956 12/21/2012 POWER LED 175 KARL STORZ ENDOSCOPY-AMERICA, INC. SHIVEN GANDHI
K123878 12/17/2012 PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING KCI USA, INC. (KINETIC CONCEPTS, INC.) SHANNON SCOTT
K123749 12/06/2012 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE KOSSAN LATEX INDUSTRIES(M)SDN BHD CHO SOW FONG
K123944 12/20/2012 KOSTEC MEDICAL GRADE LDC MONITORS KOSTEC CO., LTD RHONDA ALEXANDER, MS, MPA
K123999 12/26/2012 ILLUMASK ACNE LIGHT THERAPY MASK LA LUMIERE, LLC ROBERT SEIPLE, RAC
K124052 12/31/2012 OSTAVI HYDROPHILIC GUIDEWIRE LAKE REGION MEDICAL TRACY MEYER
K123767 12/07/2012 LANX FUSION SYSTEM- SA LANX, INC. ALAN BURKHOLDER
K124059 12/31/2012 AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT) LAUER MEMBRAN WASSERTECHNIK GMBH STEPHAN KRIETEMEYER
K123859 12/14/2012 TBD LENSAR, INC. SHIRLEY K MCGARVEY
K123955 12/21/2012 QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT LIFE TECHNOLOGIES CORPORATION DEANNA VELLA
K123842 12/13/2012 LAWMAX DILATOR LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. LILY SHI
K124043 12/28/2012 LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM LIGHTMED CORP. JOCELYN LIU
K123800 12/10/2012 WRIST AUTOMATIC BLOOD PRESSURE MONITOR LITTLE DOCTOR ELECTRONIC (NANTONG) CO., LTD. SELINA QIAN
K123414 12/20/2012 SPECBOARD JR. MACBRUD CORP., MEDICAL DIVISION TODD LARY
K123697 12/03/2012 MATRICEL DENTAL BARRIER MEMBRANE MATRICEL GMBH DR. INGO HESCHEL
K123908 12/19/2012 OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES MATRIX SURGICAL USA JULIE STEPHENS
K124003 12/26/2012 MED-FIBERS SURGICAL LASER FIBER, MED-FIBERS ENDO-ENT LASER PROBES, MED-FIBERS END- AND ASPIRATING LASER PROBES, MED-FIBE MED-FIBERS, INC. ARMIN KAUS PHD
K123721 12/04/2012 GMK REVISION EXTENSION MEDACTA INTERNATIONAL ADAM GROSS
K124034 12/28/2012 MECTALIF ANTERIOR MEDACTA INTERNATIONAL ADAM GROSS
K124000 12/26/2012 MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM MEDAPPS INC., DBA ALERE CONNECT KENT DICKS
K123866 12/17/2012 TANYX MEDECELL US, INC RHONDA ALEXANDER, M.S., M.P.A.
K123802 12/10/2012 EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT MEDICA CORP. PHOTIOS MAKRIS
K123807 12/11/2012 SHARPSCAN MEDICAL ENGINEERING DEVELOPMENT SOLUTIONS, INC. TIM CORESSEL
K124060 12/31/2012 MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM MEDICALGORITHMICS S.A. MARTIN JASINSKI
K123771 12/07/2012 KYPHON EXPRESS II INFLATABLE BONE TAMPS MEDTRONIC HETAL JAWAHAR THAKKER
K124004 12/26/2012 NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS MEDTRONIC NAVIGATION, INC. MICHAEL BLASCO
DEN120017 12/21/2012 Medtronic DUET External Drainage and Monitoring System MEDTRONIC NEUROSURGERY DONOVAN MAY
K123978 12/26/2012 CAPSTONE L SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA LAUREN KAMER
K123809 12/11/2012 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. SOWMYA SHETTY
K123906 12/19/2012 VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. CLAIRE EVANS
K123691 12/03/2012 MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM) MEDTRONIC SOFAMOR DANEK, INC. MURIEL ASHIE
K123990 12/26/2012 SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING MEDTRONIC VASCULAR KELLEY LAMKE
K123988 12/26/2012 ANYONETM INTERNAL IMPLANT SYSTEM MEGAGEN IMPLANT CO., LTD APRIL LEE
K123870 12/17/2012 XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM MEGAGEN IMPLANT CO., LTD. APRIL LEE
K123792 12/10/2012 HORIZON XVU (FFR) MENNEN MEDICAL LTD. IFAT SHWARTS
K123926 12/26/2012 METASURG NITINOL STAPLE IMPLANT METASURG JOSHUA SCOTT
K124010 12/27/2012 ACCUSONIC ADVANTAGE METRON MEDICAL AUSTRALIA PTY LTD DAVID MITCHELL
K124007 12/26/2012 SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY MICRO THERAPEUTICS, INC D/B/A: EV3 INC ANALIA STAUBLY
K123343 12/10/2012 THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS MICROGENICS CORP. KAREN LEE
K123518 12/21/2012 ABBOTT CARBAMAZEPINE ASSAY MICROGENICS CORPORATION KAREN LEE
K124029 12/28/2012 MICROLINE FLEXIBLE LIGATING SHEARS MICROLINE SURGICAL, INC DEAN CIPORKIN
K123847 12/14/2012 MALLEABLE TIP ENDOSCOPIC APPLICATOR MICROMEDICS, INC. JODI L RAUS
K123980 12/26/2012 SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES MISONIX, INC. RONALD MANNA
K123892 12/18/2012 MEPILEX TRANSFER AG MOLNLYCKE HEALTH CARE ANGELA L BUNN, RAC
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K123902 12/18/2012 PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) OKTX LLC MARY ROSE C REASTON
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K123811 12/11/2012 STITCHKIT ORIGAMI SURGICAL LLC JOHN GILLESPIE
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K123930 12/20/2012 VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III ORTHO-CLINICAL DIAGNOSTICS, INC. MICHAEL M BYRNE
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K124044 12/31/2012 ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTS SEVEN OAKS RANCH, INC. CALLEY HERZOG
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K123508 12/06/2012 TRINIAS SHIMADZU CORP. YOSHIHIRO MUKUTA
K123850 12/14/2012 IFUSE IMPLANT SYSTEM SI-BONE, INC. CINDY DOMECUS
K123920 12/20/2012 SYNGO.VIA SIEMENS AG, MEDICAL SOLUTIONS SABINE SCHROEDEL
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K123922 12/20/2012 SYNGO DYNAMICS SIEMENS MEDICAL SOLUTIONS USA, INC. YURI IKEDA
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K123813 12/19/2012 VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE VASONOVA INC. CHRISTINE FORD
K123773 12/10/2012 X-TRA BASE VOCO GMBH T. GERKENSMEIER
K123482 12/04/2012 REFLOW ASPIRATION CATHETER VOLCANO CORPORATION BRIAN PARK
K123898 12/18/2012 VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM VOLCANO CORPORATION JWALA JAWHARKAR
K123732 12/05/2012 HYSTEROSCOPY PUMP HM6 W.O.M. WORLD OF MEDICINE AG SUSANNE RAAB
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K123770 12/07/2012 WARMING JELLY PERSONAL LUBRICANT WISCONSIN PHARMACAL CO., LLC JOHN NYGAARD
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K123702 12/03/2012 SILEX SACROILIAC JOINT FUSION SYSTEM X-SPINE SYSTEMS, INC. DAVID KIRSCHMAN, M.D.
K123780 12/10/2012 TRANSTEK BLOOD PRESSURE MONITOR ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. LEO WANG
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