FDA 510(k) Applications Received During April, 2014

FDA 510(k) Number Submission Date Device Name Applicant Contact
K140938 04/11/2014 OSTOM-I ALERT 11 HEALTH AND TECHNOLOGIES LLC E J SMITH
K141081 04/25/2014 FILTEK BULK FILL POSTERIOR RESTROATIVE 3M ESPE DENTAL PRODUCTS SCOTT ERICKSON
K140925 04/11/2014 ACUMED SUTURE ANCHOR SYSTEM ACUMED, LLC LINO TSAI
K141038 04/22/2014 ANT MODEL 1 ADVANCED NUCLIDE TECHNOLOGIES, LLC SERGEY BAKLANOV, PH.D.
K140915 04/10/2014 EXCIA TOTAL HIP SYSTEM AESCULAP IMPLANT SYSTEMS, LLC JULIE T WING
K140839 04/02/2014 CAIMAN SEAL AND CUT TECHNOLOGY AESCULAP, INC. DENISE ADAMS
K141065 04/24/2014 CONSTELLATION VISION SYSTEM ALCON RESEARCH, LTD. ROBERT LUNDBERG
K140933 04/11/2014 ALIVECOR HEART MONITOR ALIVECOR, INC. Albert Boniske
K141041 04/23/2014 APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE APTUS ENDOSYSTEMS BURT GOODSON
K141033 04/22/2014 SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV ARGENTUM MEDICAL, LLC C. RICHARD FOSTER
K141051 04/24/2014 VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU ARROW INTERNATIONAL, INC. FRANK PELC
K140871 04/04/2014 AXERA 2 ACCESS SYSTEM ARSTASIS, INC. GRACE LI
K140992 04/17/2014 ARTHROCARE NASASTENT CMC NASAL DRESSING ARTHROCARE CORPORATION MITCHELL DHORITY
K140944 04/14/2014 1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP ATHEROMED INC JEAN CHANG
K140955 04/14/2014 MTA2.1 MATERIAL AVALON BIOMED INC. CAROLYN PRIMUS
K140829 04/01/2014 UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT BECKMAN COULTER, INC. ANNETTE HELLIE
K140911 04/09/2014 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM BECKMAN COULTER, INC. BRENT LEMBERG
K140816 04/01/2014 POWDER FREE NITRILE EXAMINATION GLOVE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) BETTER CARE PLASTIC TECHNOLOGY CO., LTD. KATHY LIU
K140837 04/02/2014 LUCID LY BIO-MED USA INC. YOUNG CHI
K140916 04/10/2014 LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK BIO-RAD LABORATORIES SUZANNE PARSONS
K141073 04/25/2014 LIQUICHEK TUMOR MARKER CONTROL BIO-RAD LABORATORIES SUZANNE PARSONS
K140908 04/09/2014 JUGGERKNOT MINI SOFT ANCHOR BIOMET SPORTS MEDICINE GARY BAKER
K140891 04/08/2014 BIOMET CANNULATED SCREW SYSTEM BIOMET, INC. VICTORIA SCHEITLIN
K140902 04/09/2014 E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1 SERIES PATELLAE, ASYMMETRICAL, 3-PEG BIOMET, INC. AMY L WALRIVEN
K140883 04/07/2014 VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT BIOMET, INC. JOHN HECKAMAN
K141112 04/30/2014 STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CAROL TIFFANY
K141025 04/21/2014 ARTIMES BALLOON DILATATION CATHETER BROSMED MEDICAL STEPHEN LEE
K140856 04/03/2014 BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS C.R. BARD, INC. MICHELE DAVIS
K140843 04/02/2014 DESARA BLUE OV, DESARA BLUE SS CALDERA MEDICAL VICKI GAIL
K140940 04/14/2014 PROCESS INDICATOR TAPE FOR STEAM STERILIZATION CANADIAN TECHNICAL TAPE, LTD. GARY SOCOLA
K140999 04/18/2014 TANDEMHEART VENO-VENOUS CANNULA CARDIACASSIST INC. Greg Johnson
K140831 04/04/2014 MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR CAREFUSION LARRY WALKER
K140850 04/03/2014 GENESIS REUSABLE RIGID CONTAINER SYSTEM CAREFUSION 2200, INC. JANE WEBER
K141068 04/24/2014 ZEISS CATARACT SUITE MARKERLESS CARL ZEISS MEDITEC AG SARAH HARRINGTON
K140851 04/03/2014 INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION CDR YON YU, PHARM.D.
K140857 04/03/2014 INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION CDR YON YU, PHARM.D.
K141034 04/22/2014 AZUL PERSONAL LUBRICANT CHURCH & DWIGHT CO., INC. JOSEPH CICONE
K140945 04/14/2014 COMPACTCATH INTERMITTENT URINARY CATHETER COMPACTCATH INC GREGORY MATHISON
K140833 04/02/2014 ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA SHAH
K141043 04/23/2014 CS2 MULTI-HOLE ACETABULAR SHELL CONSENSUS ORTHOPEDICS, INC MATTHEW M HULL
K140953 04/14/2014 GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER CONVATEC LTD. CLARE WILLIAMSON
K140930 04/11/2014 VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES CONVIDA HEALTHCARE & SYSTEMS CORPORATION SHARON LEE
K140813 04/02/2014 REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES COVIDIEN DANIEL CAMPION
K140825 04/01/2014 DELWORKS DR SYSTEM DEL MEDICAL, INC. DANIEL KAMM
K141007 04/18/2014 DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE DEMETECH CORP. ANTHONY DIMERCURIO
K140896 04/08/2014 VAPR ARCTIC SUCTION ELECTRODE DEPUY MITEK, A JOHNSON & JOHNSON COMPANY SUSAN KAGAN
K140880 04/07/2014 DEVILBISS SMARTLINK II SYSTEM DEVILBISS HEALTHCARE LLC BETTY MILLER
K140822 04/02/2014 DRIVE RAIL SYSTEM DEVISE ORTHO, INC. ALEX GREENE
DEN140016 04/22/2014 STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE DEXCOM, INC. ANDREW BALO
K141116 04/30/2014 LIAISON XL ANALYZER DIASORIN, INC. Mari Meyer
K140809 04/03/2014 CLIQ DV-300 ASPIRATOR DING HWA CO., LTD. JANNA BABSON
K141006 04/18/2014 RSP HUMERAL SOCKET INSERT DJO GLOBAL CHRISTINE CHESNUTT
K140849 04/03/2014 ISOSEED ECKERT & ZIEGLER BEBIG GMBH SVEN LANGER
K141023 04/21/2014 PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM ELLIPSE TECHNOLOGIES, INC. REBECCA SHELBURNE
K140830 04/02/2014 EXPRT REVISION KNEE ENCORE MEDICAL, L.P. TEFFANY HUTTO
K140904 04/09/2014 RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6 ENCORE MEDICAL, L.P. TEFFANY HUTTO
K140846 04/03/2014 EDS COMBO-RINSE ESSENTIAL DENTAL SYSTEMS, INC. JEFFREY WAN
K141122 04/30/2014 HARMONIC SCALLOP BLADE, GENERATOR G11 ETHICON ENDO-SURGERY, LLC EMILY KRUETZKAMP
K141118 04/30/2014 NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER EV3 INC LAURA J LIND
K141019 04/21/2014 AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED FENWAL, INC. KIM FORCH
K141106 04/29/2014 FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM FOLSOM METAL PRODUCTS, INC. DBA FRONTIER DEVICES KEVIN ETHERIDGE
K141067 04/24/2014 VIVID T8/VIVID T8 PRO GE HEALTHCARE BRYAN BEHN
K141074 04/25/2014 CORTEX ID SUITE GE MEDICAL SYSTEMS, LLC DAVID DUERSTELER
K141093 04/28/2014 6VT-D ULTRASOUND TRANSDUCER GE VINGMED ULTRASOUND AS BRYAN BEHN
K140996 04/25/2014 MAMMI GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION-GEM IMAGIN JOSE MONTES
K140875 04/04/2014 OPTOSSOL COMPRESSION DEVICE SYSTEM GENOSSIS, LLC BARRY E SANDS
K141063 04/24/2014 LINSCAN 808, LINSCAN 980 GME (GERMAN MEDICAL ENGINEERING) GMBH MIKE JOHNSON, M.D.
K140869 04/03/2014 DCAS I GP&P CO., LTD. CHARLIE MACK
K140924 04/14/2014 STARCERAM H.C. STARCK CERAMICS GMBH MAUREEN O'CONNELL
K140899 04/08/2014 HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEM HALO MEDICAL TECHNOLOGIES, LLC JENNIFER L KINNEY
K140890 04/08/2014 NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU) HARTALEGA NGC SDN. BHD. NURUL AISYAH KONG
K140988 04/17/2014 POWDER FREE STERILE LATEX SURGICAL GLOVE, YELLOW COLOR (BRAND NAME: TITANFINE) HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD CHARLES SHEN
K140434 04/01/2014 MEDICAD CLASSIC HECTEC GMBH THOMAS WENGENMAYER
K140934 04/11/2014 HIOSSEN IMPLANT SYSTEM HIOSSEN INC. PATRICK LIM
K140854 04/03/2014 INTRA-OPERATIVE ULTRASOUND TRANSDUCER HITACHI ALOKA MEDICAL, LTD. ANGELA VANARSDALE
K141021 04/21/2014 POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR HL RUBBER INDUSTRIES SDN BHD NOORZALIZA AHMAD
K140960 04/17/2014 PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM HOLOGIC, INC. GAIL YAEKER-DAUNIS
K140841 04/02/2014 TABLO CARTRIDGE HOME DIALYSIS PLUS NANCY GALLO
K140866 04/03/2014 TABLO CONSOLE HOME DIALYSIS PLUS NANCY GALLO
K141102 04/30/2014 HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE HOSPIRA, INC. TOM GUTIERREZ
K140929 04/09/2014 Z1 CPAP SYSTEM HUMAN DESIGN MEDICAL, LLC MAUREEN O'CONNELL
K140928 04/11/2014 ABPM7100 I.E.M. GMBH ARNE BRIEST
K140876 04/07/2014 VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC JAN TRIANI
K141069 04/24/2014 Lung Density Analysis IMBIO LLC JASON SHEARD
K141027 04/22/2014 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP IMPLANTECH ASSOCIATES INC. STEPHEN MEADE
K140886 04/07/2014 WALKAIDE SYSTEM INNOVATIVE NEUROTRONICS INC. GLEN NEALLY
K140805 04/01/2014 ITCLAMP 50 INNOVATIVE TRAUMA CARE INC RICHARD WAITE
K140967 04/14/2014 FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK INSIGHTRA MEDICAL LISA MALONEY
K140903 04/10/2014 NUVIS ARTHROSCOPE INTEGRATED ENDOSCOPY, INC. ANIL BHALANI
K141075 04/25/2014 SINGLE-SITE WRISTED NEEDLE DRIVER INTUITIVE SURGICAL EINAV YEMINI
K141077 04/25/2014 DA VINCI FIREFLY IMAGING SYSTEM INTUITIVE SURGICAL, INC. MELISSA S GONZALEZ
K141059 04/24/2014 NATURAL RUBBER LATEX MALE CONDOMS KAREX INDUSTRIES SDN BHD MARY GOH
K140964 04/15/2014 CALCULASE II KARL STORZ ENDOSCOPY-AMERICA, INC. WINKIE WONG
K140963 04/15/2014 KIMGUARD SMART-FOLD STERILIZATION WRAP KIMBERLY-CLARK CORP. THOMAS KOZMA, PH.D.
K141071 04/25/2014 KIMGUARD ONE-STEP STERILIZATION WRAP KIMBERLY-CLARK HEALTH CARE THOMAS KOZMA, PH.D.
K140976 04/16/2014 ENADEN FLOW KM CORPORATION PRISCILLA CHUNG
K141109 04/29/2014 APERIO EPATHOLOGY EIHC IVD SYSTEM LEICA BIOSYSTEMS IMAGING, INC. CHRISTINE KISHI
K140975 04/16/2014 MASTERSL FEMORAL STEM LIMACORPORATE S.P.A. STEPHEN PEOPLES
K141055 04/24/2014 LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML) LIN-ZHI INTERNATIONAL, INC. BERNICE LIN
K141045 04/23/2014 MBD PLATE SYSTEM MBD MEDICAL, LLC JENNIFER A DAUDELIN
K140909 04/09/2014 MCKESSON RADIOLOGY MCKESSON MEDICAL IMAGING COMPANY PAUL SUMNER
K140965 04/15/2014 MULTIPIEZO PRO, MULTIPIEZO MECTRON SPA ROGER GRAY
K140826 04/01/2014 GMK SPHERE EXTENSION MEDACTA INTERNATIONAL ADAM GROSS
K141044 04/23/2014 M.U.S.T. EXTENSION MEDACTA INTERNATIONAL ADAM GROSS
K140799 04/03/2014 CELERITY SYSYEM MEDCOMP (MEDICAL COMPONENTS, INC.) LORRAINE M HANLEY
K140812 04/01/2014 MI-750 PROCEDURAL/MINOR SURGICAL LIGHT MEDICAL ILLUMINATION INTERNATIONAL, INC. ROBERT HESS
K140927 04/11/2014 UNIVERSAL NAVIGATION INSTRUMENTS MEDOS INTERNATIONAL SARL KIRSTEN LEHMULLER
K140759 04/08/2014 BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERAL MEDOS INTERNATIONAL, SARL LINDA BERNIER
K141090 04/28/2014 NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER MEDTRONIC INC. JOHN KILMARTIN
K140972 04/16/2014 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING MEDTRONIC, INC. DEBRA TAITAGUE
K141083 04/28/2014 MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K140862 04/03/2014 MONICA NOVII WIRELESS PATCH SYSTEM MONICA HEALTHCARE LTD. CARL BARRATT
K140970 04/16/2014 ONE-PIECE PEEK FUSION IMPLANT MTP SOLUTIONS LLC ROBERT HOY
K141061 04/24/2014 REMOTEYE VIEWER NEOLOGICA S.R.L. MARCO SAMBIN
K141103 04/29/2014 INTRAMEDULLARY NAIL AND SCREWS-NEONAIL NEOORTHO PRODUTOS ORTOPEDICOS S/A KEVIN A THOMAS
K140947 04/14/2014 COMPAT ENTERAL DELIVERY PUMP SETS NESTLE HEALTHCARE NUTRITION, INC. M.W.(ANDY) ANDERSON
K140956 04/14/2014 LCD MONITOR NORDICNEUROLAB CHANDANA G BHANDARI
K140962 04/15/2014 NORMED VARIO SUBTALAR SCREW NORMED NEDIZIN TECHNIK GMBH DAVID FURR
K140946 04/14/2014 NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE NovaBone Products, LLC Lisa Simpson
K140921 04/10/2014 COROENT SMALL INTERBODY SYSTEM NUVASIVE, INCORPORATED Cynthia Adams
K141012 04/21/2014 HYDROCLEANSE WOUND CARE SOLUTION OCULUS INNOVATIVE SCIENCES BRIAN W MARTIN
K141060 04/24/2014 CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT ON-X LIFE TECHNOLOGIES, INC. JOHN ELY
K141079 04/25/2014 OPTIMEDICA CATALYS PRECISION LASER SYSTEM OPTIMEDICA CORPORATION STEVE JWANOUSKOS
K141001 04/18/2014 ALPINE HIP STEM; ALPINE HA HIP STEM ORTHO DEVELOPMENT MIKE ENSIGN
K140807 04/01/2014 COMPOSITE ORTHODONTIC BRACKETS ORTHO SPECIALTIES PAULA WENDLAND
K141078 04/25/2014 ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX) ORTHOFIX SRL CHERYL WAGONER
K141004 04/18/2014 INTRAOSSEOUS FIXATION SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. BRIAN HOCKETT
K140868 04/03/2014 STRYKER KWIC NEEDLE ORTHOVITA, INC. JOHN URTZ
K140917 04/10/2014 INTRODUCER, MODEL ADELANTE MAGNUM OSCOR INC. LAURA SOBRIN
K140937 04/11/2014 OSSEOFLEX SB OSSEON LLC KEITH BURGER
K140845 04/02/2014 LEVO TINNITUS MASKING SOFTWARE DEVICE OTOHARMONICS CORP YARMELA PAVLOVIC
K140923 04/10/2014 TRACTION POLYPECTOMY SNARE OVESCO ENDOSCOPY AG TANJA LINZER
K141028 04/22/2014 COLONGLIDE LUBRICANT PEDIATRIC PHARMACEUTICALS INC. ROBERT M HARRIS
K140884 04/07/2014 SYMETREX LONG TERM HEMODIALYSIS CATHETER PHASE ONE MEDICAL ADITYA SUKTHANKAR
K141015 04/21/2014 INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN MARKUS STACHA
K140808 04/01/2014 Q-STATION PHILIPS ULTRASOUND, INC. PENNY GRECO
K140865 04/03/2014 INFRARED HEATING DEVICE PRO MEDICAL SUPPLIES, INC. DORIS DONG
K141018 04/21/2014 ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT PROCTER & GAMBLE CO. MICHAEL KAMINSKI, PH.D.
K140998 04/18/2014 PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL QUALITY ELECTRODYNAMICS, LLC. KATHLEEN ARAS
K141101 04/29/2014 LITHO QUANTA SYSTEM, S.P.A. Maurizio Bianchi
K140991 04/17/2014 RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE RANFAC CORP. CHRISTOPHER P WHELAN
K141091 04/28/2014 RAYSERT PLUS INJECTOR RAYNER INTRAOCULAR LENSES LTD. JULIETTE COOK
K141072 04/25/2014 SUPOLENE RESORBA MEDICAL GMBH KARL-JOSEF BECK
K140887 04/07/2014 COBAS CT/NG V2.0 TEST ROCHE MOLECULAR SYSTEMS, INC. WILK VON GUSTEDT
K140910 04/09/2014 CENTERCROSS CATHETER ROXWOOD MEDICAL, INC. MEHRDAD FARHANGNIA
K140835 04/02/2014 GENERAL AND PLASTIC SURGERY SCION MEDICAL TECHNOLOGIES LLC CHRIS LEWIS
K140874 04/04/2014 GH DISPOSABLE AND GH REUSABLE BLOOD PRESSURE CUFF SHANGHAI GOAHUI RUBBER AND PLASTIC COMPANY RHONDA ALEXANDER, MS, MPA
K141076 04/25/2014 GARMENT ELECTRODES SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. QILIAN LIU
K141010 04/25/2014 M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS., CO. LTD. WU ZICUI
K141049 04/23/2014 IFUSE IMPLANT SYSTEM SI-BONE, INC. ROXANNE DUBOIS
K140842 04/02/2014 DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART Siemens Healthcare Diagnostics Inc. FRANCES A DILLON
K140859 04/03/2014 DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT Siemens Healthcare Diagnostics Inc. FRANCES A DILLON
K140818 04/01/2014 IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN C SIEMENS HEALTHCARE DIAGNOSTICS INC. ERNEST JOSEPH
K140959 04/15/2014 ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS SIEMENS MEDICAL SOLUTIONS USA, INC. CHRISTINE DUNN
K140912 04/09/2014 SOMATOM SCOPE/SOMATOM SCOPE POWER SIEMENS MEDICAL SOLUTIONS USA, INC. EVE DAVIS
K140897 04/10/2014 SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL SIEMENS MEDICAL SOLUTIONS USA, INC. CORDELL L FIELDS, ESQ.
K140892 04/08/2014 DISTAL ELBOW PLATING SYSTEM SKELETAL DYNAMICS, LLC ANA M ESCAGEDO
K141058 04/24/2014 ENSIZOR ENDOSCOPIC SCISSORS SLATER ENDOSCOPY, LLC CRAIG PAGAN
K140879 04/07/2014 BIOSURE HEALICOIL PK INTERFERENCE SCREW Smith & Nephew, Inc VIVEK MUKHATYAR
K140814 04/01/2014 EVOS MINI-FRAGMENT PLATING SYSTEM SMITH & NEPHEW, INC. SAMANTHA STAUBACH
K140941 04/14/2014 PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH SOFRADIM PRODUCTION CLARE SANTULLI
K141113 04/30/2014 SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE SPACELABS HEALTHCARE LTD. AL VAN HOUDT
K140948 04/14/2014 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM SPINEART FRANCK PENNESI
K141050 04/23/2014 ENSITE VELOCITY SYSTEM ST. JUDE MEDICAL DONNA R LUNAK
K140878 04/07/2014 STRAUMANN BONE LEVEL TAPERED IMPLANT STRAUMANN USA, LLC CHRISTOPHER KLACZYK
K141095 04/28/2014 STRYKER STERI-SHIELD FLYTE HYBRID TOGAS STRYKER CORPORATION JULIA HELGESON
K141056 04/24/2014 TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS STRYKER ORTHOPAEDICS KAREN ARIEMMA
K140961 04/15/2014 HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM Stryker Trauma AG NESLI KARAKAYA, RAC
K140819 04/03/2014 SURGICAL NAVIGATION ADVANCED PLATFORM SURGICAL THEATER, LLC MORDECHAI AVISAR
K140844 04/02/2014 BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC SYNERGY BIOMEDICAL, INC. RANDY PREBULA
K140834 04/02/2014 TERASON USMART3400 ULTRASOUND SYSTEM TERATECH CORP. BEN CHIAMPA
K140894 04/08/2014 ARGEN PMMA THE ARGEN CORPORATION CRAIG JOLICOEUR
K141100 04/29/2014 OPTILITE C1 INACTIVATOR KIT THE BINDING SITE GROUP LTD MARIANNE SENDER
K140985 04/16/2014 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATES THERMO FISHER SCIENTIFIC CYNTHIA KNAPP
K141000 04/18/2014 SENSITITRE SUSCEPTIBILITY PLATES THERMO FISHER SCIENTIFIC CYNTHIA KNAPP
K141029 04/22/2014 TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM TORNIER, INC. KRISTINE TUCKER
K140942 04/14/2014 KLASSIC KNEE TIBIAL STEM EXTENSION TOTAL JOINT ORTHOPEDICS, INC. JEAN WHEELER
K141097 04/28/2014 CSC SERIES INTRALUMINAL STAPLER FOR SINGLE USE TOUCHSTONE INTERNATIONAL MEDICAL SCIENCE CO., LTD. JO QIAO
K141119 04/30/2014 CAMERA ENABLED PROBE TRICE MEDICAL, INC. TIFFINI DIAGE
K140919 04/10/2014 RESPICONNECT ADAPTER TRUDELL MEDICAL INT'L DARRYL FISCHER
K140864 04/03/2014 VELOXTM INTERBODY FUSION SYSTEM U&I CORP. JI YEA LEE
K140823 04/01/2014 PERMANENT BEACON TRANSPONDER/SOFT TISSUE BEACON TRANSPONDER VARIAN MEDICAL SYSTEMS, INC. LISA LEVINE
K140966 04/15/2014 VONFLEX S BITE VERICOM CO., LTD. Myung-Hwan Oh
K141002 04/18/2014 VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM VISIONSENSE LTD. RAYMOND KELLY
K140993 04/17/2014 IONOSTAR MOLAR VOCO GMBH T GERKENSMEIER
K141026 04/22/2014 LEADERFLEX VYGON JILLIAN MIKOVICH
K140877 04/07/2014 VERICORE ZIRCONIA BLANKS WHIP MIX CORP. JOHN WATERS
K140952 04/22/2014 CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW WRIGHT MEDICAL TECHNOLOGY, INC. LESLIE FITCH
K141011 04/18/2014 G-FORCE GEN 2 SUTURE ANCHOR SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. DMITRI FALKNER
K140853 04/03/2014 STIMPOD ST2-3010 NERVE STIMULATOR XAVANT TECHNOLOGY (PTY) LTD BRIAN ROTHMAN
K140951 04/14/2014 YEESCOPE LARYNGOSCOPES YEESCOPE PTY. LTD. PAUL DRYDEN
K141005 04/18/2014 Z-LINK CERVICAL ZAVATION, LLC JOHN WALKER
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