FDA 510(k) Applications Received During December, 2011

FDA 510(k) Number Submission Date Device Name Applicant Contact
K113845 12/28/2011 TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE MEDTRONIC INC. KEVIN T LAM
K113601 12/05/2011 AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM AAP IMPLANTATE AG MARC SEEGERS
K113602 12/05/2011 AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM AAP IMPLANTATE AG MARC SEEGERS
K113648 12/12/2011 LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF AAP IMPLANTATE AG MARC SEEGERS
K113652 12/12/2011 LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF T AAP IMPLANTATE AG MARC SEEGERS
K113704 12/16/2011 ARCHITECT HAVAB-G ABBOTT LABORATORIES JUDITH WALLACH
K113719 12/19/2011 SAFETY SCREW CONNECTOR ABBOTT LABORATORIES ELIZABETH M ZOLA
K113658 12/12/2011 AMPLATZER VASCULAR PLUG 4 AGA MEDICAL CORP. SHERRY KOLLMANN
K113810 12/23/2011 MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES ALMA LASERS INC. TATIANA EPSTEIN
K113849 12/29/2011 HQS INTRODUCER ALSEAL JEAN-FRANCOIS DELFORGE
K113779 12/22/2011 CONELOG IMPLANT SYSTEM ALTATEC GMBH LINDA SCHULZ
K113555 12/01/2011 AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE AM USA KAREN THOMISON
K113639 12/09/2011 C2 MEDICAL GLOVES AMERCARE, INC. ANDREW LOWERY
K113131 12/30/2011 LIASYS 450 AMS STEFANO CORRADI
K113785 12/23/2011 ADHERENT VISUAL STIMULATOR GOGGLES ANSCHEL TECHNOLOGY, INC. GLEN PARK
K113805 12/23/2011 FIXATE TISSUE BAND ANULEX TECHNOLOGIES, INC RACHEL KENNEDY
K113547 12/01/2011 GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL APEX BIOTECHNOLOGY CORP. HSUE-MEI LEE
K113569 12/02/2011 APNEARX APNEA SCIENCE CORPORATION GARY MOCNIK
K113762 12/21/2011 CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM ARTHROSURFACE, INC. DAWN J WILSON
K113716 12/19/2011 ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIRE ASAHI INTECC CO., LTD. YOSHI TERAI
K113812 12/23/2011 ATAL-8 ATLAIM DANIEL KAMM
K113831 12/27/2011 PRIMUS HEARING INSTRUMENT TEST UNIT AUDITDATA A/S DAN HAUGBOL
K113836 12/28/2011 BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM) AVERY DENNISON BELGIE, BVBA JERZY WOJCIK
K113838 12/28/2011 WILDCAT CATHETER AVINGER, INC. SEVRINA CIUCCI
K113703 12/16/2011 BAUSCH + LOMB NESOFILCON A CONTACT LENS BAUSCH & LOMB INCORPORATED BARBARA KLUBE-FALSO
K113852 12/29/2011 BAUSCH & LOMB IOL INJECTOR BAUSCH & LOMB, INC. JASON SMITH
K113558 12/01/2011 BD BACTEC PLUS AEROBIC/F (PLASTIC) BECTON, DICKINSON AND COMPANY PAUL SWIFT
K113791 12/22/2011 B-GENIN, R-GENIN BERKELEY ADVANCED BIOMATERIALS, INC. FRANCOIS GENIN
K113610 12/06/2011 ANA-SCREEN WITH MDSS BIO-RAD LABORATORIES JUANG WANG
K113858 12/30/2011 MEGABEAM ENDO-ENT PROBE BIOLITEC MEDICAL DEVICES, INC HARRY HAYES
K113792 12/23/2011 MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBE BIOLITEC MEDICAL DEVICES, INC HARRY HAYES
K113709 12/19/2011 MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE BIOLITEC MEDICAL DEVICES, INC HARRY HAYES
K113688 12/15/2011 MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM BIOLITEC MEDICAL DEVICES, INC HARRY HAYES
K113305 12/02/2011 VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE BIOMERIEUX, INC. JOLYN TENLLADO
K113645 12/12/2011 REGENEROSS ALLOGRAFT PLUS MINERLIZED BIOMET INTERPORE CROSS KATHLEEN OLIVARES
K113550 12/01/2011 VANGUARD COMPLETE KNEE SYSTEM BIOMET MANUFACTURING CORP. GARY BAKER
K113593 12/05/2011 NEXTGEN ALTIUS OCT SYSTEM BIOMET SPINE (AKA EBI, LLC) VIVIAN KELLY
K113764 12/21/2011 GLUCOSE METER-CHECK SOLUTION FOR INFOPIA BIONOSTICS, INC. RANDY BYRD
K113822 12/27/2011 QUADRASPHERE 30 TO 60 BIOSPHERE MEDICAL, INC. LINDA J VARROSO
K113832 12/27/2011 SONICEYE ULTRASOUND TRANSDUCER BLACKTOE MEDICAL III, INC. KENDRA RATHKEY
K113681 12/15/2011 GLADIATOR PTA BALLOON DILATION CATHETER BOSTON SCIENTIFIC AMBER JOHNSON
K113651 12/12/2011 INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM BOSTON SCIENTIFIC CORPORATION HARLAN JONES
K113732 12/19/2011 IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE) BRAINLAB AG ALEXANDER SCHWIERSCH
K113866 12/30/2011 PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX BRENNEN MEDICAL, LLC KENNETH B HERLAND
K113589 12/05/2011 BIGBOSS CATHETER BRIDGEPOINT MEDICAL JILL MUNSINGER
K113811 12/23/2011 V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION ANASTASIA C RANDALL
K113808 12/23/2011 THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) C.R. BARD, INC. HENRY BOLAND
K113835 12/27/2011 DATACAPTOR SYSTEM CAPSULE TECH INC. PETER KELLEY
K113707 12/16/2011 STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES TATYANA BOGDAN
K113854 12/29/2011 PLEURX PERITONEAL CATHETER SYSTEM CAREFUSION JOY GREIDANUS
K113813 12/23/2011 SENTRYSUITE PRODUCT LINE CAREFUSION GERMANY 234 GMBH ELMAR NIEDERMEYER
K113842 12/28/2011 CATHETER CONNECTIONS' DUALCAP SOLO CATHETER CONNECTIONS, INC. DONALD D SOLOMON
K113628 12/08/2011 AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES CATHETER ROBOTICS INC JENNIFER ENGLUND
K113618 12/07/2011 CLEARCORRECT SYSTEM CLEARCORRECT, INC. CHERYL FISHER
K113731 12/19/2011 ESENSOR RESPIRATORY VIRAL PANEL CLINICAL MICRO SENSORS, INC. JOEL CENTENO
K113585 12/05/2011 NASAL/EPISTAXIS PACK COGENT THERAPEUTICS, LLC ANNE WORDEN
K113757 12/21/2011 ASPIRE MAX ASPIRATION CATHETER CONTROL MEDICAL TECHNOLOGY, LLC SHAWN P FOJTIK
K113634 12/09/2011 INJEKT CYSTO FLEXIBLE INJECTION NEEDLE COOK IRELAND LTD LAURA GUINANE
K113759 12/21/2011 AVAIRA (ENFILCON A) CONTACT LENS COOPERVISION, INC. KARIN GASTINEAU
K113572 12/02/2011 LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H JOHN VAN HOVEN
K113738 12/20/2011 CREODENT SOLIDEX CUSTOM ABUTMENT CREODENT PROSTHETICS LTD. CALVIN SHIM
K113660 12/13/2011 COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL CRYOTHERAPY PRODUCTS INC. JORGE CABALLERO
K113548 12/01/2011 PEDCAT CURVEBEAM, LLC DAVID W COWAN
K113543 12/01/2011 ONDEMAND3D CYBERMED, INC. YONG KI IM
K113787 12/22/2011 DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES DEFIBTECH, LLC ED HORTON
K113545 12/01/2011 VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN DEPUY MITEK, A JOHNSON & JOHNSON COMPANY SUSAN KAGAN
K120014 12/29/2011 STA- COAG CONTROL (N+ABN) PLUS DIAGNOSTICA STAGO, INC. KEVIN WYCKOFF
K113798 12/23/2011 INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET DRAEGER MEDICAL SYSTEMS, INC. BETH A ZIS
K113689 12/15/2011 DUKAL LUBRICATING JELLY DUKAL CORPORATION PATRICK J LAMB
K113796 12/23/2011 SOLITAIRE-C CERVICAL SPACER SYSTEM EBI, LLC MARGARET CROWE
K113623 12/05/2011 PATIENT MONITOR EDAN INSTRUMENTS, INC. RANDY JIANG
K113653 12/12/2011 PATIENT MONITOR EDAN INSTRUMENTS, INC. RANDY JIANG
K113667 12/13/2011 CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING EDWARDS LIFESCIENCES, LLC. KAREN JONES
K113565 12/02/2011 MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN EDWARDS LIFESCIENCES, LLC. MARGUEITE THOMLINSON
K113562 12/01/2011 3MP COLOR LCD MONITOR, RADIFORCE RX340 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K113784 12/22/2011 3MP MONOCHROME LCD MONITOR, RADIFORCE GX40 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K113844 12/28/2011 RADIFORCE RX240 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K113695 12/16/2011 ELLIPSE PRECICE TRAUMA NAIL SYSTEM ELLIPSE TECHNOLOGIES, INC. JOHN MCLNTYRE
K113756 12/21/2011 HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA ENCORE MEDICAL, L.P. TEFFANY HUTTO
K113726 12/19/2011 EPOC CHLORIDE TEST AND EPOC CREATININE TEST EPOCAL, INC. ROY LAYER
K113767 12/21/2011 MOUNTED MEDICAL OXYGEN SYSTEM ESSEX INDUSTRIES, INC. KEN SEISE
K113576 12/06/2011 DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM ETVIEW LTD. YORAM LEVY
K113743 12/20/2011 EVOLUTION 3E VENTILATOR EVENT MEDICAL, INC. RICK WATERS
K113609 12/06/2011 NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5 EXACTECH, INC. VLADISLAVA ZAITSEVA
K113564 12/02/2011 EXSALT T7 WOUND DRESSING EXCITON TECHNOLOGIES INC. MELANIE USSYK
K113761 12/21/2011 INFRARED THERMOMETER FAMIDOC TECHNOLOGY CO., LTD LEON CAO
K113702 12/16/2011 FOTONA XP ND: YAG LASER SYSTEM FOTONA D.D. STOJAN TROST
K113591 12/05/2011 COLS PEEK FOURNITURES HOSPITALIERES INDUSTRIE PATRICIA DONNARD
K113713 12/19/2011 GEN_2 MECHANICAL WHEELCHAIR FREE WHEELCHAIR MISSION SHARON ROCKWELL
K113722 12/19/2011 DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR FULL SYNERGY MEDICAL PRODUCTS INC ELIZABETH DENG
K113750 12/21/2011 DISPOSABLE POWDER FREE VINYL EXAM GLOVE, WHITE COLOR FULL SYNERGY MEDICAL PRODUCTS INC ELIZABETH DENG
K113710 12/19/2011 DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR FULL SYNERGY MEDICAL PRODUCTS INC ELIZABETH DENG
K113749 12/21/2011 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR FULL SYNERGY MEDICAL PRODUCTS INC ELIZABETH DENG
K113797 12/23/2011 DISPOSABLE VINYL EXAM GLOVE, POWDER FREE FULL SYNERGY MEDICAL PRODUCTS INC ELIZABETH DENG
K113790 12/23/2011 DISPOSABLE VINYL EXAM GLOVE, POWDERED FULL SYNERGY MEDICAL PRODUCTS INC ELIZABTEH DENG
K113860 12/30/2011 VISUAL-ICE CRYOABLATION SYSTEM GALIL MEDICAL INC. AMY MCKINNEY
K113816 12/27/2011 GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV GC AMERICA, INC. CARL H JENKINS
K113690 12/15/2011 GE LOGIQ I, LOGIQ E AND VIVID E GE HEALTHCARE BRYAN BEHN
K113758 12/21/2011 VOLUSON E6/E8/E8EXPERT/E10 GE HEALTHCARE BRYAN BEHN
K113607 12/06/2011 BIOPSY DIGIT S BIOPSY SL GIOTTO USA, LLC NICOLAAS BESSELING
K113853 12/29/2011 G+ SYSTEM GLYTEC, LLC WILLIAM MATTHEWS
K113833 12/27/2011 VITAL SIGNS MONITOR GUANGDONG BIOLIGHT MEDITECH CO., LTD DIANA HONG
K113624 12/08/2011 WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST GUANGZHOU WONDFO BIOTECH CO., LTD. JOE SHIA
K113674 12/14/2011 SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT HANDPIECE HEADQUARTERS INC. - HPR INC. TINA STEFFANIE-OAK
K113728 12/19/2011 SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY HANS BIOMED CORP. PATSY J TRISLER
K113622 12/12/2011 ORION II CT CVC HEALTH LINE INTERNATIONAL CORPORATION (HLIC) NOLA BENSTOG
K113837 12/28/2011 POWDER FREE VINYL PATIENT EXAMINATION GLOVES HEBEI CHANGSHENG PLASTIC PRODUCTS CO., LTD. RICHARD LU
K113574 12/06/2011 FLEXITIME MONOPHASE PRO SCAN HERAEUS KULZER, LLC CHRIS HOLDEN
K113575 12/02/2011 HILLA DIGITAL TRANSFERS HILLA TECHNOLOGIES, INC. CAROLYN M PRIMUS
K113809 12/23/2011 HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) HITACHI CHEMICAL DIAGNOSTICS, INC. ERICKA B AMMIRATI
K113683 12/15/2011 LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL HOSPIRA,INC. KAREN KEENER
K113769 12/22/2011 GPSCATH BALLON DILATATION CATHETER HOTSPUR TECHNOLOGIES ERIC ANKERUD
K113760 12/21/2011 VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS VALERIE GIAMBANCO
K113449 12/05/2011 FUSION FLAT PANEL ICRCO INC. GREG WACHTLER
K113662 12/07/2011 FENESTRATED NERVE BLOCK NEEDLE IMD INC WALTER ZOHMANN
K113855 12/29/2011 PANORAD, PANORAD SL IMIX ADR FINLAND OY DANIEL KAMM
K113748 12/21/2011 IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) IMRIS, INC. SANJAY SHAH
K113670 12/13/2011 ELEMENT BLOOD GLUCOSE MONITORING SYSTEM INFOPIA CO., LTD PRISCILLA CHUNG
K113863 12/30/2011 QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS INOVA DIAGNOSTICS, INC. GABRIELLA LAKOS
K113644 12/12/2011 PILOT TUBE REPAIR KIT INSTRUMENTATION INDUSTRIES, INC. DORIS F WALTER
K113570 12/02/2011 INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP INTEGRA BURLINGTON MA, INC. LINDSAY MIGNONE
K113541 12/01/2011 CLEARSTART SVM SYSTEM INTIO INC. DAVID GUSTAFSON
K113620 12/07/2011 MYRIAN 1.11 INTRASENSE FREDERIC BANEGAS
K113706 12/16/2011 ENDOWRIST STAPLER SYSTEM INTUITIVE SURGICAL, INC. MEGHNA SRIDHARAN
K113697 12/16/2011 EIGR SURGICAL ILLUMINATION SYSTEM INVUITY, INC. THERESA BRANDNER-ALLEN
K113862 12/30/2011 ZIO PATCH IRHYTHM TECHNOLOGIES, INC. MICHAEL RIGHTER
K113355 12/01/2011 POSEY BED J. T. POSEY CO. BONNIE BISHOP
K113357 12/01/2011 POSEY BED J. T. POSEY CO. BONNIE BISHOP
K113654 12/13/2011 CASPIAN K2M, INC. NANCY GIEZEN
K113685 12/15/2011 POWDER FREE LATEX EXAMINATION GLOVES KHAI HOAN JOINT STOCK COMPANY TERENCE LIM
K113806 12/23/2011 KIMGUARD ONE STEP STERILIZATION WRAP KIMBERLY-CLARK HEALTH CARE CHRISTOPHER B SWANSON
K113559 12/01/2011 LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS LDR SPINE USA INC. KIERSTEN SODERMAN
DEN110019 12/08/2011 NEBA SYSTEM LEXICOR MEDICAL TECHNOLOGY, LLC E. HOWARD MERRY
K113566 12/02/2011 OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM LIFE TECHNOLOGIES, INC. KELLI L TANZELLA
K113661 12/13/2011 LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS LIN-ZHI INTERNATIONAL, INC. BERNICE LIN
K113830 12/27/2011 VANTERA CLINICAL ANALYZER LIPOSCIENCE SUZETTE WARNER
K113616 12/07/2011 ACCUDXA2 LONE OAK MEDICAL TECHNOLOGIES, LLC DAVID COMLEY
K113843 12/28/2011 FREEDOM ND: YAG LASER SYSTEM LUTRONIC CORPORATION JHUNG WON VOJIR
K113668 12/13/2011 HEALITE II SYSTEM LUTRONIC CORPORATION JHUNG WON VOJIR
K113588 12/05/2011 SPECTRA LASER SYSTEM LUTRONIC CORPORATION JHUNG WON VOJIR
K113679 12/14/2011 LUCEA LED SURGICAL LIGHT SYSTEM MAQUET SAS WHITNEY TORNING
K113596 12/05/2011 MASIMO SET REUSABLE OXIMETRY SENSORS MASIMO CORPORATION DAVID COLLETTE
K113739 12/20/2011 SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM MATERIALISE DENTAL NV GEERT APPELTANS
K113599 12/05/2011 SURGICASE CONNECT MATERIALISE N.V. ALEXANDRA RAZZHIVINA
K113829 12/27/2011 ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNE MATERIALISE N.V. ALEXANDRA RAZZHIVINA
K113621 12/12/2011 SMARTDRIVE WHEELCHAIR POWER-ASSIST MAX MOBILITY, LLC WILLIAM M RICHTER
K113664 12/13/2011 CLOSER TO NATURE ELECTRIC BREAST PUMP MAYBORN GROUP LIMITED NEIL HEWITT
K113686 12/15/2011 KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED MAYER LABORATORIES, INC. DAVID P MAYER
K113633 12/08/2011 MCKESSON ANESTHESIA CARE MCKESSON TECHNOLOGIES INC. JANICE M HOGAN
K113571 12/02/2011 GMK RESUFACING PATELLA SIZE 4 MEDACTA INTERNATIONAL ADAM GROSS
K113678 12/14/2011 INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM MEDELA AG ADRIENNE LENZ
K113673 12/13/2011 MYSAFETY SYRINGE MEDICALCHAIN INTERNARTIONAL CORPORATION ROBIN HWANG
K113583 12/05/2011 CURAD ANTIBACTERIAL BANDAGE MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K113677 12/14/2011 GRINDCARE MEASURE MEDOTECH A/S CALLEY HERZOG
K113828 12/28/2011 DYNANAIL ANKLE ARTHRODESIS NAIL MEDSHAPE, INC JEREMY BLAIR
K113560 12/01/2011 CELOX GAUZE PRO MEDTRADE PRODUCTS LTD. CLAIRE RYAN
K113642 12/12/2011 PERIMETER INTERBODY FUSION DEVICE MEDTRONIC SOFAMOR DANEK USA LAUREN KAMER
K113577 12/05/2011 MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR MERITS HEALTH PRODUCTS CO., LTD. STEVE CHAO
K113017 12/05/2011 SYS*STIM 240 METTLER ELECTRONICS CORP. CHRISTINA CAYUELA
K113701 12/16/2011 VISIA NEURO MEVIS MEDICAL SOLUTIONS AG THOMAS E TYNES
K113698 12/16/2011 SCEPTER XC OCCLUSION BALLOON CATHETER MICRO VENTION, INC. NAOMI GONG
K113655 12/12/2011 TI-MAX X TURBINE NAKANISHI, INC. DIANE RUTHERFORD
K113717 12/19/2011 ULTRASONIC SCALER NAKANISHI, INC. DIANE RUTHERFORD
K113712 12/19/2011 IM-11 PNEUMATIC MICROINJECTOR NARISHIGE CO., LTD. MITSUKO YONEYAMA
K113638 12/09/2011 NMI 2.8 MICROCATHETER NAVILYST MEDICAL, INC. WANDA CARPINELLA
K113554 12/01/2011 CMI IMPLANT IS SYSTEM NEOBIOTECH CO., LTD. APRIL LEE
K113733 12/19/2011 SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX NEOORTHO PRODUTOS ORTOPEDICOS S/A KEVIN A THOMAS
K113771 12/22/2011 SIGNAL GEAR URETHRAL CATHETER ELECTRODE NEUROVISION MEDICAL PRODUCTS, INC. CHRISTINE VERGELY
K113763 12/21/2011 SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE NOBLES MEDICAL TECHNOLOGIES II, INC. MARIA HATEGAN
K113795 12/23/2011 SUCTION LIPOLASTY ACCESSORIES NORMAN M. BLACK III NORMAN BLACK
K113820 12/27/2011 NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER NOVABAY PHARMACEUTICALS SHEILA W PICKERING
K113608 12/06/2011 DEFLEX NUXEN S.R.L. HERNAN ILARI
K113788 12/22/2011 DEFLEX ACRILATO NUXEN S.R.L. HERNAN ILARI
K113687 12/15/2011 EQUINOX RELIEVE O-TWO MEDICAL TECHNOLOGIES, INC. DAVID ZHANG
K113725 12/19/2011 VIRTUOST O.N. DIAGNOSTICS DAVID KOPPERDAHL
K113696 12/16/2011 OPTOS ADVANCE OPTOS PLC HOWARD M HOLSTEIN
K113869 12/30/2011 ORIGEN REINFORCED DUAL LUMEN CATHETER ORIGEN BIOMEDICAL RICHARD MARTIN
K113627 12/08/2011 HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY ORTHOCON ROSEMARY HARRY
K113770 12/29/2011 ORTHOFIX GALAXY FIXATION SYSTEM ORTHOFIX SRL CANDACE F CEDERMAN
K113708 12/16/2011 ORTHOSCAN MOBILE DI MINI C-ARM ORTHOSCAN, INC. CHRIS EAVES
K113582 12/05/2011 ARCHSTENT BILIARY SYSTEM OSTIAL CORPORATION KAITLIN VON HOFFMANN
K113775 12/22/2011 FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM OSTIAL CORPORATION KAITLIN VON HOFFMANN
K113594 12/05/2011 C-THV SYSTEM PAIEON, INC. EREZ BEN-ZVI
K113724 12/19/2011 ELECTROPULSE-COSMETIC PAIN RELIEF TECHNOLOGIES KENDALL GORHAM
K113612 12/06/2011 AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A PANASONIC HEALTHCARE CO., LTD. RAM BEDI
K113781 12/22/2011 PANTHEON SPINAL IBFD SYSTEM PANTHEON SPINAL SCOTT SPANN
K113625 12/12/2011 DSS STABILIZATION SYSTEM PARADIGM SPINE, LLC MICHELLE MCDONOUGH
K113730 12/19/2011 PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS PARCUS MEDICAL, LLC PAUL VAGTS
K113839 12/28/2011 RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE PARKELL, INC. DANIEL R SCHECHTER
K113568 12/02/2011 MTA-FILLAPEX PAXMED INTERNATIONAL ALLISON KOMIYAMA
K113819 12/27/2011 MONGOOSE ANGIOGRAPHIC CATHETER PEDIACATH INC. CAROLINE TONTINI
K113873 12/30/2011 PENTAX EPK-I5020 VIDEO PROCESSOR PENTAX OF AMERICA, INC. ROBERT SCHIFF
K113841 12/28/2011 IMMUNOCAP ALLERGEN COMPONENTS BUNDLE PHADIA US INC. MARTIN MANN
K113657 12/12/2011 INTELLIVUE PATIENT MONITOR PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH MANFRED STEVER
K113636 12/09/2011 BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE) PHILOSYS CO. LTD LINDA CHAN
K113807 12/23/2011 DEXERYL CREAM PIERRE FABRE MEDICAL DEVICES DIANE MANDELL HORWITZ
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