FDA 510(k) Decisions During December, 2012  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K122760 12/07/2012 AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE MEDTRONIC INC. JULIA A NELSON
K123448 12/13/2012 AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE MEDTRONIC INC. JULIA A NELSON
K122827 12/14/2012 AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811 MEDTRONIC INC. MARY E DONLIN
K123085 12/20/2012 FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE 3M COMPANY LISA NELSON
K121495 12/07/2012 LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONG AAP IMPLANTATE AG MARC SEEGERS
K121003 12/21/2012 ABBOTT PLEX-ID FLU ASSAY ABBOTT LABORATORIES DARREN CLARKE
K123010 12/14/2012 ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM ACON LABORATORIES, INC. XIE QIYI
K121803 12/19/2012 INTRAVASCULAR ADMINISTRATION SET ACTA MEDICAL LLC JOHN BREWER
K123659 12/20/2012 TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR) ACTUATED MEDICAL, INC. DEBORA DEMERS, PHD
K123017 12/26/2012 STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324 ADVANCED STERILIZATION PRODUCTS NANCY CHU
K123683 12/27/2012 NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR AEROCRINE AB KATHLEEN RICKARD, MD
K123352 12/12/2012 S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS, INC. LISA M BOYLE
K120955 12/17/2012 COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEM AESCULAP IMPLANT SYSTEMS, LLC KATHY A RACOSKY
K122734 12/18/2012 AESCULAP NOVOSYN ABSORBABLE SUTURE AESCULAP, INC. KATHY A RACOSKY
K123419 12/27/2012 EVA SELECT DIGITAL DENTAL IMAGING SYSTEM AFP IMAGING CORP. DANIEL KAMM, P.E.
K121555 12/21/2012 CENTURION VISION SYSTEM ALCON LABORATORIES, INC. CHARLES OGBONNA
K123120 12/12/2012 LENSX LASER SYSTEM ALCON LENSX, INC. JUDY GORDON, DVM
K123611 12/21/2012 E-CUBE 7 ALPINION MEDICAL SYSTEMS CO., LTD DONGHWAN KIM
K113779 12/14/2012 CONELOG IMPLANT SYSTEM ALTATEC GMBH LINDA SCHULZ
K122753 12/14/2012 EMPOWER CLEAR AMERICAN ORTHODONTICS TRANG ADAMS
K120813 12/07/2012 BLOOD GLUCOSE MONITORING SYSTEM ANDON MEDICAL CO., LTD YI LIU
K121218 12/13/2012 HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA, ANDREW TECHNOLOGIES, LLC HERBERT CRANE
DEN090007 12/19/2012 BIO-SEAL LUNG BIOPSY TRACT SYSTEM ANGIOTECH TRUDY ESTRIDGE
K082438 12/19/2012 BIO-SEAL LUNG BIOPSY TRACT SYSTEM ANGIOTECH TRUDY ESTRIDGE
K100404 12/14/2012 ASCENDX VCF REDUCTION SYSTEM AOI MEDICAL, INC. JANICE M HOGAN
K112079 12/06/2012 APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720 APEX MEDICAL CORP. ALAN CHANG
K122248 12/05/2012 IGROW II HAIR GROWTH SYSTEM APIRA SCIENCE, INC. RAYMOND R BLANCHE
K122330 12/07/2012 FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE ARJOHUNTLEIGH POLSKA SP Z.O.O. DAVID MOYNHAM
K122690 12/21/2012 ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE ARROW INTERNATIONAL, INC. PAUL AMUDALA
K120791 12/11/2012 AMBIENT TURBOFLASH 90 IFS ARTHOCARE CORPORATION CHERYL FREDERICK
K123341 12/21/2012 ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTON ARTHREX, INC. CHRISTINA FLORES
K121661 12/27/2012 EZ-ASSIST-FILL ASSIST FILL, LLC GRIFFIN
K122892 12/11/2012 MTA2 ROOT AND PULP MATERIALS AVALON BIOMED INC. CAROLYN PRIMUS
K123462 12/07/2012 OCELOT CATHETER AVINGER, INC. ALBERT BONISKE
K123532 12/14/2012 OCELOT PIXL CATHETER AVINGER, INC. BABU PERIASAMY
K121842 12/12/2012 ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C AXIS-SHIELD DIAGNOSTICS, LTD. CLAIRE I DORA
K122575 12/20/2012 BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI BAUSCH & LOMB, INC. NANCY A FEHRMAN
K113018 12/14/2012 APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORM BEIJING SYNTECH LASER CO., LTD. DIANA HONG
K121268 12/20/2012 WANDY DISPERSVIE ELECTRODE BIO-MED USA INC. YOUNG CHI
K123663 12/27/2012 LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK BIO-RAD LABORATORIES SUZANNE PARSONS
K123451 12/03/2012 POLARIS SPINAL SYSTEM - BALLISTA II RODS BIOMET SPINE (AKA EBI, LLC) VIVIAN KELLY MS, RAC
K122784 12/27/2012 NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT BIONESS, INC. KIM TOMPKINS
K122649 12/12/2012 NAVIGATOR HD URETERAL ACCESS SHEATH SET BOSTON SCIENTIFIC CORP. HUDA YUSUF
K122794 12/18/2012 UPSYLON Y MESH BOSTON SCIENTIFIC CORP. LAUREN ANDERSON
K122459 12/13/2012 PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM BOSTON SCIENTIFIC CORPORATION MICHELLE BERRY
K122660 12/03/2012 RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612 BOSTON SCIENTIFIC CORPORATION THOMAS HIRTE
K123561 12/18/2012 ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS BSN MEDICAL, INC. CARROLL D HOYLE
K122852 12/06/2012 PHYSIOSTAR NFC CANDULOR USA, INC. DONNA MARIE HARTNETT
K121653 12/27/2012 INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS CARL ZEISS MEDITEC, INC. SARAH HARRINGTON
K123065 12/14/2012 CATHETER CONNECTIONS DUALCAP SOLO CATHETER CONNECTIONS, INC. DONALD D SOLOMON
K121710 12/27/2012 XPERT CT/NG CEPHEID RUSSEL K ENNS
K123191 12/21/2012 XPERT FLU CEPHEID RUSSEL K ENNS
K122000 12/12/2012 HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER CHANGZHOU HOLYMED PRODUCTS CO LTD ALAN YU
K121998 12/20/2012 HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM SURGICAL GOWN, POLYERINFORCED CHANGZHOU HOLYMED PRODUCTS CO LTD ALAN YU
K122208 12/20/2012 EXTERNAL FIXATOR SYSTEM CHRISTOPHER D. ENDARA CHRISTOPHER ENDARA
K122813 12/18/2012 HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM CINCINNATI SUB-ZERO PRODUCTS, INC. STEVEN J BERKE
K122968 12/18/2012 NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 COLOPLAST CORP. MARGARET BATCHELDER
K122991 12/20/2012 ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA SHAH
K123260 12/21/2012 DETACHATIP III CONMED CORPORATION LISA ANDERSON
K122937 12/14/2012 SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX) COOK, INC. AMBER BROWN
K121514 12/14/2012 ANODYNE ANTERIOR CERVICAL PLATE SYSTEM CORELINK LLC JUSTIN EGGLETON
K120146 12/11/2012 QUARK SERIES COSMED S.R.L. ROBERT SCHIFF
K123318 12/18/2012 IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO HEALTHCARE SARAH RIZK
K111105 12/20/2012 CURASAN OSSEOLIVE DENTAL CURASAN AG ROGER GRAY
K121853 12/13/2012 DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES DEFIBTECH, LLC ED HORTON
K122927 12/20/2012 OXICARE FINGERTIP PULSE OXIMETER DELBIO INCORPORATED NICKY PAN
K120866 12/11/2012 DA01 BLOOD GLUCOSE MONITORING SYSTEM DELBIO INCORPORATION NICKY PAN
K121007 12/28/2012 NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1 DELTA MED SRL HARRY BONTRAGER
K122582 12/07/2012 DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C) DENTERPRISE INTERNATIONAL, INC. CLAUDE BERTHOIN
K122268 12/11/2012 ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS DENTSPLY INTERNATIONAL HELEN LEWIS
K122869 12/13/2012 MILAGRO INTERFERENCE SCREWS DEPUY MITEK, A JOHNSON & JOHNSON COMPANY KRISTINE CHRISTO
K121027 12/20/2012 DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH DIAMOND DIAGNOSTICS, INC KATHY CRUZ
K121620 12/11/2012 ULTRASONIC SURGERY DMETEC CO., LTD. DANIEL NAM
K123385 12/14/2012 MEDILAS H LASER FIBERS DORNIER MEDTECH AMERICA, INC. JOHN HOFFER
K121663 12/05/2012 CLARITY ELEKTA LTD. GEORGE PAPAGIANNIS
K123729 12/21/2012 VERSARATE FLOW RATE CONTROLER EMED TECHNOLOGIES CORPORATION PETER KOLLINGS
K122489 12/10/2012 EMERGE MEDICAL SOLID BONE SCREWS EMERGE MEDICAL VICTORIA TRAFKA
K123257 12/14/2012 EMVERA DIOLUX EMVERA TECHNOLOGIES, INC.
K120995 12/03/2012 ERAD PACS/ERAD RIS/PACS/ERAD EPVLITE VIEWER SOFTWARE PRODUCT ERAD, INC. JILLIAN M REED
K113743 12/18/2012 EVOLUTION 3E VENTILATOR EVENT MEDICAL, INC. RICK WATERS
K122814 12/03/2012 GALLEON PEDICLE SCREW SYSTEM EVEREST SPINE, LLC CHRISTINA VACCA
K121067 12/06/2012 EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE EXACTECH, INC. LINDY KNISELY
K113010 12/21/2012 FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR FAMIDOC TECHNOLOGY CO., LTD CAO LIANG
K122658 12/20/2012 FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 FEMASYS INC. LISA PEACOCK
K122432 12/06/2012 ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS FISHER & PAYKEL HEALTHCARE, LTD. ROBERT PETRY
K121508 12/12/2012 LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N FOTONA D.D. STOJAN TOST
K122954 12/19/2012 CINCHER-2.6 SUTURE ANCHOR MODEL FG-001 FOUNDRY NEWCO XI, INC. MICHAEL KOLBER
K121341 12/06/2012 FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM FRESENIUS MEDICAL CARE, NORTH AMERICA DENISE OPPERMANN
K122535 12/13/2012 FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K123255 12/20/2012 G.HLAMP G.TEC MEDICAL ENGINEERING GMBH CHRISTOPH GUGER
K113313 12/14/2012 MOLECULAR ADSORBENT RECIRCULATING(MARS) GAMBRO RENAL PRODUCTS, INC. KAE MILLER
K123564 12/18/2012 LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM GE HEALTHCARE BRYAN BEHN
K120770 12/06/2012 QT GUARD PLUS ANALYSIS SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES KRISTIN PABST
K113394 12/11/2012 MAVRIC SL GE MEDICAL SYSTEMS, LLC YUAN MA
K122948 12/21/2012 GEM-STIM COMBO STIMULATOR GEMORE TECHNOLOGY CO., LTD. BODEN S.P. LAI
K122944 12/21/2012 GEMORE TRUE SINE INTERFERENTIAL STIMULATOR GEMORE TECHNOLOGY CO., LTD. BODEN S.P. LAI
K122097 12/06/2012 PATRIOT SPACERS GLOBUS MEDICAL, INC. MERIAM YOUSSEF
K122142 12/21/2012 GLOOKO LOGBOOK CHARTS GLOOKO, INC. SHILPA MYDUR
K123113 12/11/2012 L.A.M. IMP WOUND GEL GLYCOBIOSCIENCES, INC JAMES JOHNSON
K122832 12/19/2012 MOBICATH TRANSSEPTAL NEEDLE GREATBATCH MEDICAL DENISE THOMPSON
K113377 12/14/2012 GLIADIN IGA AND GLIADIN LGA GRIFOLS USA, LLC CATHERINE L WONG
K122961 12/21/2012 WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500) GUANGZHOU WONDFO BIOTECH CO., LTD. JOE SHIA
K121398 12/13/2012 CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF) GUIDEPATH MEDICAL, INC. JOHN MITCHELL TATUM
K122605 12/05/2012 PKS BILL GYRUS ACMI, INC. NEIL KELLY
K123637 12/21/2012 HAMILTON-C3 HAMILTON MEDICAL AG RALPH AGUILA
K123278 12/07/2012 IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF HERAEUS KULZER, LLC JAMIE MEARNA
K121278 12/18/2012 HERMES MEDICAL IMAGING SUITE V5.2 HERMES MEDICAL SOLUTIONS, AB JOAKIM ARWIDSON
K120886 12/17/2012 LACRIFAST HIROYASU HIGUCHI FUMIAKI KANAI, PH.D.
K112910 12/20/2012 AP 72OS SEMI-AUTOMATED INSTRUMENT HITACHI CHEMICAL DIAGNOSTICS, INC. DONALD POSTEL
K123530 12/20/2012 MAMMOGRAPHY PRIOR ENHANCEMENT (MPE) HOLOGIC, INC. GAIL YAEKER-DAUNIS
K121369 12/19/2012 NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR IBRAMED EQUIPAMENTOS MEDICOS LILIAN LLULL
K122546 12/07/2012 SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM IDEV TECHNOLOGIES, INC. DARLENE GARNER
K121077 12/21/2012 NHANCER IMDS OPERATIONS B.V. E SCHULTING
K120946 12/17/2012 ALPHA CRYPTOCOCCAL ANTIGEN EIA IMMUNO-MYCOLOGICS, INC. SEAN K BAUMAN
K123230 12/12/2012 MOSAIQ ONCOLOGY INFORMATION SYSTEM IMPAC MEDICAL SYSTEMS, INC. KATHRYN STINSON
K123091 12/27/2012 VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T IMRIS, INC. SANJAY SHAH
K113506 12/19/2012 IND ONE STEP OCCULT BLOOD (FOB) TEST IND DIAGNOSTICS INC. KAI LOU
K120822 12/21/2012 STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, ST INSTITUT STRAUMANN AG ANDREAS PETERMANN
K122953 12/07/2012 OMNIPOD INSULIN MANAGMENT SYSTEM INSULET CORPORATION MICHAEL J DOYLE
K123000 12/21/2012 INTEGRA TOTAL FOOT SYSTEMS INTEGRA LIFESCIENCES CORPORATION STEPHEN H BEIER
K122075 12/20/2012 DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER INTERSURGICAL, INC. MICHAEL ZALEEWSKI
K123463 12/03/2012 INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS INTUITIVE SURGICAL, INC. CRYSTAL ONG
K121582 12/20/2012 INVENDO C25 COLONOSCOPY SYSTEM INVENDO MEDICAL GBMH OLIVER V RUEPPRECHT
K122897 12/21/2012 SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645 INVIVO CORPORATION LANCE AULABAUGH
K122740 12/10/2012 JETPREP FLUSHING DEVICE OL-103037, JETPREP FLUSHING DEVICE OL-133037, JETPREP FLUSHING DEVICE OL-168037, JETPREP FLUSHIN JETPREP, LTD. JOHN SMITH, MD, JD
K121152 12/12/2012 SURGICAL GOWN, SMS JIANGSU GUANGDA MEDICAL MATERIAL, CO., LTD DARREN REEVES
K123172 12/21/2012 KOGENT BIPOLAR FORCEPS KATALYST SURGICAL, LLC MONA DEAN
K122039 12/27/2012 KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B KETTENBACH GMBH & CO KG JUERGEN BERGER
K120985 12/19/2012 KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING KIMBERLY-CLARK CORP. MARCIA JOHNSON
K112695 12/12/2012 CRYOTOP KITAZATO BIOPHARMA CO;LTD RICHARD VINCINS CQA,RAC(US,EU)
K123499 12/20/2012 AEROPILOT KONICA MINOLTA MEDICAL & GRAPHIC, INC. RUSSELL MUNVES
K121046 12/20/2012 STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. HEATHER VIELE
K122421 12/11/2012 TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID KURARAY NORITAKE DENTAL INC. MICHIO TAKIGAWA
K122474 12/28/2012 LANSINOH POWERED ELECTRIC BREAST PUMP LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SAN, TIC. LTD CALLEY HERZOG
K123531 12/14/2012 UNBALLOON NON-OCCLUSIVE MODELING CATHETER LEMAITRE VASCULAR, INC. BRYAN COWELL, RAC
K122829 12/03/2012 LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS LENSAR, INC. SHIRLEY K MCGARVEY
K122414 12/21/2012 AB COMMAND DUAL CHANNEL FITNESS BELT LETO ENTERPRISES INCORPORATION SABRINA WEI
K112898 12/21/2012 DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS LIMACORPORATE S.P.A. CHERYL HASTINGS
K123031 12/03/2012 BWF-5 MEDICAL LASER SERIES LITECURE, LLC LIANG LU
K120454 12/07/2012 SAFEAIR SMOKE PENCIL, LNA MEDICAL APS RICK GILLIS, PH.D
K112644 12/19/2012 SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM LOTUS BIO LTD LORI KAHLER
K123466 12/20/2012 HEALTHVIEW ECG MANAGER LUMEDX CHRIS PEARCE
K121640 12/05/2012 ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM MATERIALISE N.V. ALEXANDRA RAZZHIVINA
K122322 12/06/2012 PIEZOSURGERY TOUCH MECTRON S.P.A. ROGER GRAY
K121703 12/07/2012 LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE MEDI-KHAN USA, INC KACHI ENYINNA
K122764 12/28/2012 RAPID STRAND RX MEDI-PHYSICS, INC. DAVID RISLEY
K122423 12/12/2012 VASU-PICC MEDICAL COMPONENTS INC JESSICA LEO
K120956 12/12/2012 VSP SYSTEM MEDICAL MODELING INC JONATHAN S KAHAN
K120844 12/13/2012 MEDLINX SURGICAL MESH MEDLINX ACALA PTE LTD STEPHEN P RHODES
K123167 12/28/2012 DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM MEDOS INTERNATIONAL SARL EUGENE BANG
K123771 12/21/2012 KYPHON EXPRESS II INFLATABLE BONE TAMPS MEDTRONIC HETAL JAWAHAR THAKKER
K123591 12/27/2012 FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) MEDTRONIC CRYOCATH LP VANESSA WARE
K123568 12/18/2012 VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. MIKE SCOTT
K122321 12/19/2012 BASIXCONPAK ANALOG INFLATION SYRINGE MERIT MEDICAL IRELAND, LTD. STEPHANIE ERSKINE
K122088 12/05/2012 MERIT ONE SNARE SYSTEM MERIT MEDICAL SYSTEMS, INC. MARK MULLANEY
K122840 12/14/2012 CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407 MICK RADIO-NUCLEAR INSTRUMENTS, INC. CHUCK SMITH
K120936 12/13/2012 ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS MICROGENICS CORPORATION KAREN LEE
K120628 12/19/2012 HELIO MOTION COMPOSITES VINCENT LECUYER
K123197 12/05/2012 VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) NANOSPHERE, INC MARK DEL VECCHIO
K121117 12/14/2012 NDX ABUTMENTS NATIONAL DENTEX CORP LINDA K SCHULZ
K120356 12/11/2012 NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD NCS LAB SRL MATTEO MANTOVANI
K113771 12/13/2012 SIGNAL GEAR URETHRAL CATHETER ELECTRODE NEUROVISION MEDICAL PRODUCTS, INC. CHRISTINE VERGELY
K122217 12/19/2012 CERTUS 140 2.45GHZ ABLATION SYSTEM NEUWAVE MEDICAL, INC DAN KOSEDNAR
K120490 12/27/2012 QUICK SAMPLER HOLDER NIPRO MEDICAL CORPORATION JESSICA OSWALD
K122874 12/10/2012 POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE NITRILIST GLOVES MANUFACTURING SDN BHD LAU SIONG HUT
K122435 12/20/2012 NOVA ONE BLOOD GLUCOSE MONITOR NOVA BIOMEDICAL CORPORATION PAUL W MACDONALD
K120237 12/11/2012 BPA-FREE MICROHYBID COMPOSITE NOVOCOL, INC. CORA BRACHO-TROCONIS
K122742 12/07/2012 NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM NUVASIVE, INC. SHEILA BRUSCHI
K113023 12/21/2012 STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER NXSTAGE MEDICAL, INC. MARY LOU STROUMBOS
K123359 12/19/2012 OVS1 VIDEO SYSTEM OLIVE MEDICAL CORP. BRIAN DEAN
K120357 12/20/2012 ENDOSCOPE REPROCESSOR OER-MINI OLYMPUS MEDICAL SYSTEMS CORP. LAURA STORMS-TYLER
K122831 12/14/2012 VIDEO SYSTEM CENTER OLYMPUS MEDICAL SYSTEMS CORP. SHERI L MUSGNUNG
K123317 12/11/2012 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N OLYMPUS MEDICAL SYSTEMS CORPORATION SHERI L MUSGNUNG
K123319 12/14/2012 GYRUS ACMI BICOAG HEMOSTASIS PROBE OLYMPUS SURGICAL TECHNOLOGIES AMERICA NEIL KELLY
K122759 12/05/2012 OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA) OMEGA LABORATORIES, INC. ROBERT J BARD
K123357 12/28/2012 ONQ RTS ONCOLOGY SYSTEMS, INC. CARL WALKER
K122603 12/19/2012 ONTEX AND OTHER PROPRIETARY NAMES ONTEX BVBA ROBERT J STAAB
K122875 12/18/2012 ORICARE L2700 ORICARE, INC. DAVID T JAMISON
K122901 12/03/2012 FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM ORTHOFIX JACKI GEREN
K123203 12/14/2012 MAXLOCK EXTREME SYSTEM MODEL MXL ORTHOHELIX SURGICAL DESIGNS, INC. DEREK LEWIS
K122958 12/13/2012 DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY OSCOR INC. MILA DOSKOCIL
K122960 12/13/2012 STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO OSCOR INC. MILA DOSKOCIL
K121843 12/11/2012 NP-CAST ABUTMENT SYSTEM OSSTEM IMPLANT CO.,LTD PATRICK LIM
K122861 12/07/2012 XTOOL OUROBOROS MEDICAL SHELLEY TRIMM
K122152 12/14/2012 OXTI INFLATION DEVICE OXTI CORPORATION JOSEPH J CHANG
K120282 12/10/2012 CARDNAV PAIEON, INC. SHIMON VAKNIN
K122018 12/10/2012 OP300 PALODEX GROUP OY MATTI TULIKOURA
K122034 12/06/2012 MRJ 3300 PARAMED SRL LUISELLA DEBENEDETTI
K122975 12/20/2012 GKS PRIME FLEX CR TOTAL KNEE SYSTEM PERMEDICA NATALIE J KENNEL
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