FDA 510(k) Decisions During February, 2012  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K112271 02/16/2012 3B WILLOW 3B PRODUCTS, LLC ALEX LUCIO
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
K113197 02/02/2012 APC FLASH-FREE ADHESIVE 3M UNITEK CORPORATION ROBERT WANG
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
K111874 02/16/2012 FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS ABBOTT LABORATORIES ARUL STERLIN
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
K120163 02/17/2012 ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM ACUTE INNOVATIONS LLC MARIAH KNIGHT
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
K111959 02/06/2012 AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE AESCULAP, INC. 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
K082438 12/19/2012 BIO-SEAL LUNG BIOPSY TRACT SYSTEM ANGIOTECH TRUDY ESTRIDGE
DEN090007 12/19/2012 BIO-SEAL LUNG BIOPSY TRACT SYSTEM ANGIOTECH TRUDY ESTRIDGE
K113744 02/01/2012 QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE) ANGIOTECH KIRSTEN STOWELL
K113805 02/23/2012 FIXATE TISSUE BAND ANULEX TECHNOLOGIES, INC RACHEL KENNEDY
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
K120143 02/16/2012 ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL APOLLO SPINE MICHELE LUCEY
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
K120155 02/17/2012 ARTHREX KNOTLESS SUTURETAK ANCHOR ARTHREX, INC. CHRISTINA FLORES
K123341 12/21/2012 ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTON ARTHREX, INC. CHRISTINA FLORES
K113762 02/06/2012 CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM ARTHROSURFACE, INC. DAWN J WILSON
K113716 02/06/2012 ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIRE ASAHI INTECC CO., LTD. YOSHI TERAI
K113452 02/17/2012 ACU-CUT VERTEBRAL AUGMENTATION SYSTEM ASCENDX SPINE, INC. JANICE M HOGAN
K121661 12/27/2012 EZ-ASSIST-FILL ASSIST FILL, LLC GRIFFIN
K113165 02/02/2012 MINI-MEDIC ATHENA GTX SEAN MAHONEY
K111018 02/14/2012 POLYFUSE - NEUROBONE ATPAC MEDICAL LLC GARY MALINOWSKI
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
K120147 02/17/2012 ACE STAPLER AND CARTRIDGE BAROSENSE, INC SHEILA STEVENS, PHD
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
K111860 02/16/2012 BD MAX GBS ASSAY, BD MAX INSTRUMENT BECTON DICKINSON & CO. MARY ANNE WILLIAMS
K113018 12/14/2012 APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORM BEIJING SYNTECH LASER CO., LTD. Diana Hong
K113065 02/22/2012 RL, UL, SL, EL, AND EPL VERTICAL PLATFORM LIFTS BELLA ELEVATOR, LLC RICK CRANE
K120392 02/16/2012 CHROMOPHARE F 628 AND F 528 BERCHTOLD GMBH & CO. KG VOLKER HORNSCHEIDT
K120189 02/22/2012 BONETRAP BERNI FARNS INCORPORATED NICOLA BERNI
K103044 02/10/2012 AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION BESTGEN BIOTECH CORP. STEVEN SHEN
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
K111976 02/17/2012 VITEK 2 STREPTOCOCCUS ERYTHROMYCIN BIOMERIEUX, INC. JENNIFER CHIA-HSUAN LIN
K113305 02/10/2012 VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE BIOMERIEUX, INC. JOLYN TENLLADO
K111893 02/28/2012 VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE BIOMERIEUX, INC. JOLYN TENLLADO
K113550 02/29/2012 VANGUARD COMPLETE KNEE SYSTEM BIOMET MANUFACTURING CORP. GARY BAKER
K123451 12/03/2012 POLARIS SPINAL SYSTEM - BALLISTA II RODS BIOMET SPINE (AKA EBI, LLC) VIVIAN KELLY MS, RAC
K120121 02/16/2012 COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE BIOMET, INC. PATRICIA BERES
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
K113007 02/27/2012 BIONIME DIABETES MANAGEMENT SYSTEM VI.0 BIONIME CORPORATION Feng-Yu Lee
K113401 02/07/2012 ORTHO-1(NOT FINALIZED) BISCO, INC. Michelle Schiltz-Taing
K110375 02/23/2012 BLUESHINE'S GOLD SERIES BLUESHINE SRL CHIARA RICCI
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
K112994 02/10/2012 CRE DITATATION BALLON Boston Scientific Corporation JANIS TARANTO
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
K120129 02/03/2012 MANTARAY CATHETER BRIDGEPOINT MEDICAL JILL MUNSINGER
K120137 02/14/2012 VICTORY GUIDEWIRE (32 MODELS) BRIVANT, LTD. KENNETH WALSH
K113308 02/01/2012 BRUNO ELAN STAIRWAY ELEVATOR BRUNO INDEPENDENT LIVING AIDS, INC. TERRENCE O'BRIEN
K123561 12/18/2012 ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS BSN MEDICAL, INC. CARROLL D HOYLE
K113276 02/27/2012 CATALYST C-RAD POSITIONING AB JANINA OSTLING
K112841 02/16/2012 SURFACE BEACON TRANSPONDERS CALYPSO MEDICAL TECHNOLOGIES INC MARCIA PAGE
K122852 12/06/2012 PHYSIOSTAR NFC CANDULOR USA, INC. DONNA MARIE HARTNETT
K112831 02/16/2012 PLEURX PLEURAL CATHETER SYSTEMS CAREFUSION JOY GREIDANUS
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
K113359 02/03/2012 CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBE CHISON MEDICAL IMAGING CO., LTD. BOB LEIKER
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
K120081 02/17/2012 NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS CINCINNATI SUB-ZERO PRODUCTS, INC. STEVEN J BERKE
K111937 02/08/2012 CLEARFLASH AC2100 COSMETIC SYSTEM CLEARFLASH TECHNOLOGIES, INC. JOSEPH NEEV
K120229 02/24/2012 ENVOY DISTAL ACCESS GUIDING CATHETER Codman & Shurtleff, Inc. CATHERINE KILSHAW
K113496 02/14/2012 VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT COLOPLAST A/S JANELL COLLEY
K122968 12/18/2012 NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 COLOPLAST CORP. MARGARET BATCHELDER
K120068 02/03/2012 CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS) CONFORMIS, INC. AMITA SHAH
K113378 02/15/2012 CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA S SHAH
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
K112650 02/01/2012 CONNEXALL SUITE OF SOFTWARE PRODUCTS CONNEXALL USA, INC. THOMAS KROENKE
K112099 02/03/2012 CONTOUR HEALER CONTOUR HEALER, LLC ALLEN HARDIN WHITE
K113757 02/22/2012 ASPIRE MAX ASPIRATION CATHETER CONTROL MEDICAL TECHNOLOGY, LLC SHAWN P FOJTIK
K113634 02/14/2012 INJEKT CYSTO FLEXIBLE INJECTION NEEDLE COOK IRELAND LTD LAURA GUINANE
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
K110404 02/16/2012 EAUM TOTAL KNEE SYSTEM CORENTEC CO., LTD KEVIN A THOMAS
K111481 02/06/2012 CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS CORIN U.S.A. LUCINDA GERBER
K120146 12/11/2012 QUARK SERIES COSMED S.R.L. ROBERT SCHIFF
K120258 02/29/2012 DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H JENNIFER BRENNAN
K123318 12/18/2012 IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H SARAH RIZK
K112791 02/24/2012 SITESCRUB IPA DEVICE CR BARD LYNN M KIRCHOFF
K113021 02/07/2012 TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT CSA MEDICAL, INC. COLLEEN KISTLER
K111105 12/20/2012 CURASAN OSSEOLIVE DENTAL CURASAN AG ROGER GRAY
K111726 02/06/2012 PATHWAY AVID CUSTOM SPINE, INC. DAVID DRUMFIELD
K111411 02/01/2012 FREEMIE (R) DAO HEALTH DAN GARBEZ
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
K113343 02/08/2012 DIACHECK SMART/SUPERIOR 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
K111689 02/16/2012 STLASE DENTAL PHOTONICS, INC Marcy Moore
K122582 12/07/2012 DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C) DENTERPRISE INTERNATIONAL, INC. Claude Berthoin
K111364 02/01/2012 HAPTITE COATING IMPLANT SYSTEM DENTIS CO., LTD. APRIL LEE
K122268 12/11/2012 ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS DENTSPLY INTERNATIONAL HELEN LEWIS
K113406 02/13/2012 AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K120078 02/29/2012 HEALIX ADVANCE BR ANCHOR DEPUY MITEK INC., JOHNSON AND JOHNSON COMPANY YAYOI FUJIMAKI
K122869 12/13/2012 MILAGRO INTERFERENCE SCREWS DEPUY MITEK, A JOHNSON & JOHNSON COMPANY KRISTINE CHRISTO
K113545 02/27/2012 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
K110078 02/10/2012 EXTRICARE DEVON MEDICAL PRODUCTS, INC. RUTH WU
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
K111758 02/14/2012 CADENS (TM) COLON DOG MICROSYSTEMS, INC. FLORENT CHANDELIER
K110821 02/27/2012 BARF BAND DOODLEBUG PRODUCTS, LLC BARRY E SANDS
K123385 12/14/2012 MEDILAS H LASER FIBERS DORNIER MEDTECH AMERICA, INC. JOHN HOFFER
K112723 02/08/2012 EPIGRAY DOSISOFT SA ROBERT J MORTON
K113206 02/17/2012 NANOBLUTM 500 Draeger Medical Systems, Inc. BRYAN OVERTON
K113250 02/09/2012 DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE DYNATRONICS CORP. DOUGLAS SAMPSON
K120144 02/14/2012 VITAL SIGNS MONITOR EDAN INSTRUMENTS INC RANDY JIANG
K113623 02/01/2012 PATIENT MONITOR EDAN INSTRUMENTS, INC. RANDY JIANG
K113653 02/06/2012 PATIENT MONITOR EDAN INSTRUMENTS, INC. RANDY JIANG
K113844 02/27/2012 RADIFORCE RX240 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K111467 02/09/2012 FLEXI-Q DV AND DVR AUTO-INJECTORS ELCAM MEDICAL A.C.A.L. SHAY SHAHAM
K112353 02/17/2012 GEODESIC EEG MOBILE 100 (GEM 100) ELECTRICAL GEODESICS, INC. LINDA J BOVARD
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.
K120241 02/24/2012 LINEAR HIP STEM, SIZE 5 ENCORE MEDICAL, L.P. TEFFANY HUTTO
K120212 02/09/2012 AFX INTRODUCER SYSTEM ENDOLOGIX, INC. Janet M Fauls
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
K112074 02/01/2012 EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 EVERYWAY MEDICAL INSTRUMENTS CO., LTD. JAY MANSOUR
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
K120027 02/23/2012 PILAIRO NASAL PILLOWS MASK FISHER & PAYKEL HEALTHCARE LIMITED TINA MASON
K122432 12/06/2012 ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS FISHER & PAYKEL HEALTHCARE, LTD. ROBERT PETRY
K113202 02/28/2012 TISSUE MARKER FOCAL THERAPEUTICS GEORGE HERMANN
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
K120017 02/02/2012 FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM FRESENIUS MEDICAL CARE, NORTH AMERICA DENISE OPPERMANN
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.
K113722 02/14/2012 DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR FULL SYNERGY MEDICAL PRODUCTS INC ELIZABETH DENG
K113710 02/14/2012 DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR FULL SYNERGY MEDICAL PRODUCTS INC ELIZABETH DENG
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
K113403 02/14/2012 GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM GE MEDICAL SYSTEMS SCS MICHEL GENUER
K113394 12/11/2012 MAVRIC SL GE MEDICAL SYSTEMS, LLC YUAN MA
K113408 02/24/2012 Q. FREEZE (MOTION VUE2) GE MEDICAL SYSTEMS, LLC DAVID DUERSTELER
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
K110899 02/01/2012 GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT GOLD STANDARD DIAGNOSTICS NAPOLEON MONCE
K122832 12/19/2012 MOBICATH TRANSSEPTAL NEEDLE Greatbatch Medical DENISE THOMPSON
K110051 02/02/2012 RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT Greatbatch Medical SARA BAKKER
K112541 02/07/2012 Z FLEX-270TM STEERABLE SHEATH Greatbatch Medical SARA BAKKER
K113505 02/17/2012 VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER GREINER BIO-ONE NORTH AMERICA, INC. Judi Smith
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
K112006 02/09/2012 HAMILTON-TC1 HAMILTON MEDICAL AG RALPH AGUILA
K111405 02/13/2012 BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER, HANGZHOU BEVER MEDICAL DEVICES CO., LTD. ALLYSON ZHOU
K112976 02/02/2012 NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM HARTALEGA SND. BHD. NURUL A KONG
K120006 02/02/2012 HERO GRAFT HEMOSPHERE INC LAURIE LYNCH
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
K113054 02/17/2012 EQUIVITAL HIDALGO LIMITED EKTA SOOD
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K120454 12/07/2012 SAFEAIR SMOKE PENCIL, LNA MEDICAL APS RICK GILLIS, PH.D
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K111341 02/29/2012 CLEANE / CLEANE POP MEDICON CO., LTD. Priscilla Chung
K112736 02/01/2012 PASS LP SPINAL MEDICREA INTERNATIONAL J D WEBB
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K120356 12/11/2012 NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD NCS LAB SRL MATTEO MANTOVANI
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K112690 02/24/2012 BLOOD PRESSURE MONITOR NIHON SEIMITSU SOKKI CO., LTD. KOJI KUBO
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K112709 02/09/2012 STIMULATION/DISSECTION INSTRUMENTS NUVASIVE, INCORPORATED Elias Ketchum
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K122875 12/18/2012 ORICARE L2700 ORICARE, INC. DAVID T JAMISON
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K122901 12/03/2012 FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM ORTHOFIX JACKI GEREN
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K111249 02/08/2012 ORTHOSLENDERIZER ORTHOMATICS, INC. PAUL ROCKE
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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
K113724 02/15/2012 ELECTROPULSE-COSMETIC PAIN RELIEF TECHNOLOGIES KENDALL GORHAM
K113207 02/29/2012 SONO TAP, TUOHY SONO PAJUNK GMBH CHRISTIAN QUASS
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K122018 12/10/2012 OP300 PALODEX GROUP OY MATTI TULIKOURA
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K112595 02/13/2012 COFLEX-F PARADIGM SPINE, LLC MARC VISCOGLIOSI
K122034 12/06/2012 MRJ 3300 PARAMED SRL LUISELLA DEBENEDETTI
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K103039 02/15/2012 IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE PHADIA US INC. MARTIN MANN
DEN120001 02/15/2012 IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE PHADIA US INC. MARTIN MANN
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K121498 12/14/2012 PERCUNAV PHILIPS HEALTHCARE TARA MACKINNON
K123492 12/13/2012 DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L) PHILIPS MEDICAL SYSTEMS Lisa Simpson
K110825 02/16/2012 PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES PHILIPS MEDICAL SYSTEMS PAUL SCHRADER
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K123754 12/21/2012 CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM PHILIPS ULTRASOUND, INC.
K110550 02/03/2012 BRIGHT EMBRACE MODEL SBL60 PHYSICIAN ENGINEERED PRODUCTS, INC. ROBERT ROSE
K123565 12/13/2012 PRESTO 1000 SYSTEM PHYSIOSONICS, INC DAVID CRONISER
K122158 12/11/2012 PBP TOTAL HIP SYSTEM PIPELINE BIOMEDICAL PRODUCTS, LLC TERRY POWELL
K111684 02/03/2012 PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD PLAYTEX MANUFACTURING INC. PUSHPA RAO
K122376 12/19/2012 PMT TRUSCAN SURFACE ELECTRODE PMT CORP. AL IVERSEN
K122749 12/27/2012 PRESTIGE-MOBIE PRESTIGE SPORTING GOODS CO. LTD. JUNNATA CHANG
K112815 02/29/2012 QUANTUM BARIATRIC 451 PRIDE MOBILITY PRODUCT CORPORRATION KIMBERLY BLAKE
K120858 12/06/2012 IMPLANT BAR PRISMATIK DENTALCRAFT, INC. KATHLEEN DRAGOVICH
K121391 12/10/2012 INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS PRISMATIK DENTALCRAFT, INC. ARMIN ZEHTABCHI
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K113772 02/09/2012 HPR EMOLLIENT FOAM PRUGEN IP HOLDINGS, INC SEAN LONERGAN
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K112654 02/17/2012 POWDERFREE POLYISOPRENE SURGICAL GLOVES PT. MEDISAFE TECHNOLOGIES ANIL TANEJA
K123265 12/07/2012 RMGI LOW VISCOSITY PULPDENT CORPORATION KENNETH J BERK
K121266 12/11/2012 CARDIOSCOPE PULSECOR LIMITED E.J. Smith
K113323 02/06/2012 ARTUS INFL A/B RG RT-PCR KIT QIAGEN, GMBH KIM DAVIS
K113319 02/06/2012 ROTOR-GENE Q MDX QIAGEN, GMBH MELISSA MAHALL
K120290 02/28/2012 TOSHIBA 1.5T CARDIAC COIL QUALITY ELECTRODYNAMICS CHRISTIE ZYDYK
K123168 12/20/2012 Q-PLUS T+ IPL LASER SYSTEM Quanta System SpA Maurizio Bianchi
K113231 02/27/2012 WARP10,WARP75 QUANTUM DEVICES, INC. MORRIS WAXLER
K123355 12/13/2012 AMPLIVUE C. DIFFICILE ASSAY QUIDEL CORPORATION Ronald H Lollar
K120381 02/24/2012 Q50 PLUS STENT GRAFT BALLOON CATHETER QXMEDICAL, LLC
K120103 02/03/2012 REST ASSURED GENERATION III DENTAL PROTECTOR RANIR LLC GERARD J PRUD'HOMME
K122645 12/05/2012 MOBILE CAREGUIDE 2100 OXIMETER REFLECTANCE MEDICAL INC Nandini Murthy
K120178 02/08/2012 WINGMAN EXTENDABLE TIP SUPPORT CATHETER REFLOW MEDICAL Rebecca K Pine
K123398 12/18/2012 DR. SCHOLL'S COMPRESSION SOCKS RENFRO CORPORATION Rebecca K Pine
K113053 02/01/2012 BIPAP A 30 VENTILATORY SUPPORT SYSTEM RESPIRONICS, INC. ELAINE LARKIN
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K122111 12/31/2012 RESPIRONICS SIMPLYCLEAR DEVICE RESPIRONICS, INC. COLLEEN WITT
K122684 12/07/2012 REVERSE MEDICAL MICROCATHETER REVERSE MEDICAL CORPORATION JEFFREY VALKO
K123526 12/27/2012 CLEARREAD +CONFIRM RIVERAIN TECHNOLOGIES JENNIFER BUTSCH
K122242 12/05/2012 ELECSYS CA 15-3 II CALCHECK 5 Roche Diagnostics EDIE EADS
K123695 12/18/2012 TRAUS SIP10 SAESHIN PRECISION CO., LTD. Y.S. LEE
K112591 02/07/2012 SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS SAFE SECURE PACKAGING CO., LTD GARFIELD WANG
K123226 12/05/2012 LESSRAY SAFERAY SPINE, LLC Calley Herzog
K120268 02/10/2012 AMID STAPLER SAFESTICH MEDICAL, LLC ALINA CARABALLO
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