FDA 510(k) Applications Received During May, 2013

FDA 510(k) Number Submission Date Device Name Applicant Contact
K131442 05/20/2013 FIRECR DENTALIMAGING SYSTEM 3DISC AMERICAS DANIEL KAMM
K131404 05/15/2013 FLASH AR PENTA / FLASH AR PENTA QUICK 3M DEUTSCHLAND GMBH DESI W SOEGIARTO
K131459 05/20/2013 AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K131508 05/24/2013 VYSIS D7S486/CEP 7 FISH PROBE KIT ABBOTT MOLECULAR, INC. NANCY W BENGTSON
K131506 05/24/2013 AIRWAY SUPPORT SYSTEM / AIRPORT ABEON MEDICAL CORPORATION ALLISON SLAGA
K131300 05/07/2013 THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER ACCESS SCIENTIFIC, LLC ALBERT MISAJON
K131469 05/21/2013 ACON ON CALL DIABETES MANAGEMENT SOFTWARE ACON LABORATORIES, INC. QIYI XIE
K131428 05/17/2013 RADVISION ACOUSTIC MEDSYSTEMS, INC. JENNIFER WILLIAMS
K131380 05/14/2013 ACUMED TOTALW RIST FUSION PLATING SYSTEM ACUMED LLC BRITTANY CUNNINGHAM
K131383 05/14/2013 X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE ADVANCED BRAIN MONITORING INC. ADRIENNE LENZ
K131571 05/30/2013 AVD RIGHT RADIAL DRAPE ADVANCED VASCULAR DYNAMICS MATTHEW SEMLER
K131500 05/24/2013 YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS AESCULAP, INC. KATHY A RACOSKY
K131408 05/15/2013 CR 12-X DIGITIZER AGFA HEALTHCARE N.V. SHAEANN CAVANAGH
K131386 05/14/2013 EZ-OX PLUS GENERATION II AIR LIQUIDE HEALTHCARE AMERICA ANGIE BEYER
K131313 05/07/2013 ACTIVE BREATHING COORDINATOR AKTINA MEDICAL CORP. TONY SPACCAROTELLA
K131515 05/28/2013 ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT ALFA WASSERMANN HYMAN KATZ, PH.D.
K131351 05/10/2013 ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC HYMAN KATZ
K131488 05/23/2013 ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC HYMAN KATZ
K131531 05/28/2013 TIANKANG DISPOSABLE SYRINGES WITH RE-USE PREVENTION FEATURE WITH OR WITHOUT NEEDLE ANHUI TIANKANG MEDICAL PRODUCTS CO., LTD XIUMING CHONG
K131474 05/22/2013 ARTHREX DISTAL RADIUS PLATE SYSTEM ARTHREX, INC. COURTNEY SMITH
K131377 05/14/2013 HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT ARTHROSURFACE, INC. DAWN J WILSON
K131360 05/13/2013 INTEGRA TITANIUM BONE WEDGE ASCENSION ORTHOPEDIC KYLA KARA
K131407 05/15/2013 BAHADIR STERILIZATION TRAYS BAHADIR USA CORP. ISMAIL KILIC
K131246 05/01/2013 CORONIS 3MP BARCO N.V. LIEVEN DE WANDEL
K131295 05/06/2013 NIO COLOR 3MP LED BARCO NV LIEVEN DE WANDEL
K131546 05/29/2013 AU BICARBONATE REAGENT BECKMAN COULTER IRELAND INC DAVID G DAVIS
K131301 05/07/2013 BD FACS SAMPLE PREP ASSISTANT III BECTON DICKINSON & CO. KIMBERLY LIEDTKE
K131358 05/10/2013 BD PEN NEEDLE BECTON DICKINSON & CO. PASQUALE AMATO
K131331 05/09/2013 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML) BECTON, DICKINSON & CO. MONICA E GIGUERE
K131299 05/07/2013 ANYTHINK PACS WORKSTATION BEIJING CREALIFE TECHNOLOGY CO., LTD. WEIHUA ZHOU
K131423 05/16/2013 G-ARM MULTISCAN SYSTEM BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD. BETTER LI
K131519 05/28/2013 BELMONT HYPERTHERMIA PUMP BELMONT INSTRUMENT CORP. SABRINA BELLADUE
K131327 05/08/2013 BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM BIO COMPRESSION SYSTEMS, INC. Maureen Garner
K131306 05/07/2013 IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE BIO COMPRESSION SYSTEMS, INC. Maureen Garner
K131353 05/10/2013 COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE BIOMET MANUFACTURING CORP. PATRICIA S BERES
K131393 05/15/2013 MAK OSS FEMORAL KNEE COMPONENTS BIOMET ORTHOPEDICS CORP. GARY BAKER
K131510 05/24/2013 POLYDIMETHYLSILOXANE IMPRESSION MATERIAL BLACKWELL DEVICE CONSULTING ANGELA BLACKWELL
K131475 05/22/2013 BARRICADE EMBOLIZATION COIL SYSTEM BLOCKADE MEDICAL Rebecca K Pine
K131562 05/30/2013 BREATHE NIOV VENTILATION SYSTEM BREATHE TECHNOLOGIES CRAIG COOMBS
K131234 05/01/2013 LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON) BRONCUS MEDICAL INC MAHTAB FATEMI
K131496 05/23/2013 BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE) BSN MEDICAL, INC. CARROLL D HOYLE
K131402 05/15/2013 VISICLEAR SMOKE EVACUATION SYSTEM BUFFALO FILTER CO., INC. CARRIE TERMIN
K131493 05/23/2013 SIDEKICK AND USHER SUPPORT CATHETERS C.R. BARD, INC. TIMOTHY WADE
K131523 05/28/2013 CRYOBALLOON FOCAL ABLATION SYSTEM C2 THERAPEUTICS PETER GARCIA-MEZA
K131538 05/29/2013 CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM CAPTIVA SPINE RICH JANSEN
K131332 05/09/2013 CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER CARDIOSOLUTIONS INC MICHELE LUCE
K131251 05/01/2013 TRINITY ELE Carol Cole Company Rand Daoud
K131325 05/08/2013 QUATTRO GL SUTURE ANCHOR CAYENNE MEDICAL, INC. KERESHMEH SHAHRIARI
K131526 05/28/2013 SFI-BAR CENDRES & METAUX SA TANJA BONGNI
DEN130005 05/28/2013 QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS CENTERS FOR DISEASE CONTROL AND PREVENTION ELIZABETH HAMELIN
K131303 05/07/2013 DISPOSABLE CIRCULAR STAPLER CHANGZHOU CITY ZHIYE MEDICAL DEVICES INSTITUTE CO. CHARLIE MACK
K131511 05/28/2013 DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR CHANGZHOU SINOLINKS MEDICAL INNOVATION CO., LTD Diana Hong
K131305 05/07/2013 CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE CHISON MEDICAL IMAGING CO., LTD. BOB LEIKER
K131363 05/13/2013 ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM CILAG GMBH INTERNATIONAL Oyinkan Donaldson
K131528 05/28/2013 NON-PYROGENIC ULTRASOUND TRANSDUCER COVER CIVCO MEDICAL INSTRUMENTS CO., INC. AMANDA STAHLE
K131443 05/20/2013 COALIGN INNOVATIONS ACCULIF XL IBF CAGE COALIGN INNOVATIONS, INC. JUSTIN EGGLETON
K131240 05/01/2013 COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT COCHLEAR AMERICAS SEAN BUNDY
K131541 05/29/2013 FLEXIBLE COOAGEN NERVE CUFF COLLAGEN MATRIX, INC. PEGGY HANSEN
K131437 05/20/2013 MODIFIED CONCENTRIC MICROCATHETER CONCENTRIC MEDICAL, INC. CHRISTINA ROWE
K131492 05/23/2013 MODIFIED FLOWGATE BALLOON GUIDE CATHETER CONCENTRIC MEDICAL, INC. RHODA SANTOS
K131467 05/21/2013 ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA SHAH
K131552 05/30/2013 CONVENTUS DRS CONVENTUS ORTHOPAEDICS KENT LIND
K131378 05/14/2013 SUS (STENFILCON A) CONTACT LENS COOPERVISION, INC. ANNETTE NELSON
K131522 05/28/2013 CORE PEDICLE SCREW SYSTEM CORE-NEXUS LISA PETERSON
K131520 05/28/2013 NEXUS ANTERIOR CERVICAL PLATE SYSTEM CORE-NEXUS LISA PETERSON
K131250 05/02/2013 TIGER SPINE SYSTEM CORELINK LLC MEREDITH MAY
K131532 05/28/2013 ELECTROMAGNETIC TRANSMITTING STYLET CORPAK MEDSYSTEMS STEPHANIE WASIELEWSKI
K131258 05/02/2013 SATURN DENTAL IMPLANT CORTEX DENTAL IMPLANTS INDUSTRIES, LTD SIMHA SIBONY
K131252 05/02/2013 PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM COVIDIEN MICHAEL AYMAMI
K131361 05/13/2013 WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET COVIDIEN STACEY A STRAND
K131525 05/28/2013 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES DEFIBTECH, LLC Ed Horton
K131385 05/14/2013 EASY-GRAFT Degradable Solutions AG DEBORAH LAVOIE GRAYESKI
K131292 05/06/2013 DEROYAL SPINE SPACER SYSTEM DEROYAL INDUSTRIES, INC. KAREN E WARDEN, PHD
K131464 05/21/2013 EXTRICARE NPWT FOOT DRESSING DEVON MEDICAL INC. RUTH WU
K131441 05/20/2013 LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II DIASORIN, INC. Sandra Zimniewicz
K131556 05/29/2013 DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET DIAZYME LABORATORIES Abhijit Datta
K131572 05/31/2013 MICRO AMBULATORY ECG RECORDER DIMETEK DIGITAL MEDICAL TECHNOLOGIES LTD JIMMY GUAN
K131248 05/01/2013 ETCH GEL DMG AMERICA, LLC PAMELA PAPINEUA, RAC
K131302 05/07/2013 SOLAX DONGGUAN PRESTIGE SPORTING GOODS CO., LTD. JUNNATA CHANG
K131379 05/14/2013 EARLYSENSE EARLYSENSE LTD. DALIA ARGAMAN
K131323 05/08/2013 ECLERIS SINUSCOPE Ecleris USA RAYMOND J KELLY, IV
K131503 05/24/2013 SE-601 SERIES ELECTROCARDIOGRAPH EDAN INSTRUMENTS, INC. CHERRY SUN
K131498 05/24/2013 IQQA-LIVER MULTIMODALITY SOFTWARE EDDA TECHNOLOGY, INC. DANIEL KAMM, P.E.
K131588 05/31/2013 VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR EDWARDS LIFESCIENCES, LLC. SALLY MAHER
K131396 05/15/2013 WIRED MOUTH PROTECTOR (WMP) ELBA LABORATORIES, INC. RICHARD A HAMER
K131376 05/14/2013 SMARTCOAT 2.5% NAF VARNISH ELEVATE ORAL CARE STEVE PARDUE
K131490 05/23/2013 ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM ELLIPSE TECHNOLOGIES, INC. John McIntyre
K131480 05/22/2013 EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM EMERGE MEDICAL VICTORIA TRAFKA
K131422 05/16/2013 PEERSCOPE SYSTEM ENDOCHOICE, INC. TAMAR FUERST
K131435 05/20/2013 ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW, ETHICON ENDO-SURGERY, LLC MARICA ARENTZ
K131392 05/14/2013 ETIAM PACS COMPONENTS ETIAM S.A.S.U. GERALDINE TESSENS
K131570 05/30/2013 ORTHOVISION EWOO SOFT CO., LTD DAVE KIM
K131575 05/31/2013 EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT EXACTECH, INC. PATRICK HUGHES
K131298 05/06/2013 EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM EXACTECH, INC. SHING JEN TAI, PHD
K131266 05/03/2013 TREZ_HD EXCEL-TECH LTD. (XLTEK) DANIEL RAMIREZ
K131530 05/28/2013 DYNAMESH -CICAT FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESEL NEIL R ARMSTRONG
K131516 05/28/2013 PRISMAFLEX SYSTEM 7.10 GAMBRO RENAL PRODUCTS, INC. KAE MILLER
K131527 05/28/2013 LOGIQ S8 GE HEALTHCARE BRYAN BEHN
K131267 05/03/2013 VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10 GE HEALTHCARE BRYAN BEHN
K131414 05/16/2013 CARESCAPE MONITOR B850 GE HEALTHCARE FINLAND OY JOEL KENT
K131576 05/31/2013 OPTIMA CT660 GE MEDICAL SYSTEMS, LLC HELEN PENG
K131514 05/28/2013 GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM GE VINGMED ULTRASOUND AS BRYAN BEHN
K131264 05/03/2013 KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS GEBR. BRASSELER GMBH & CO. KG ERELA DANA
K131338 05/09/2013 DERMA HOOD GLOBALMEDIA GROUP, LLC NICHOLAS CAMPBELL
K131449 05/20/2013 COALITION SPACER GLOBUS MEDICAL, INC. CHRISTINA KICHULA
K131330 05/08/2013 GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT GOLD STANDARD DIAGNOSTICS NAPOLEON MONCE
K131334 05/09/2013 HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST GOLD STANDARD DIAGNOSTICS NAPLEON MONCE
K131468 05/21/2013 DENRACLE DENTAL ABUTMENT GREEN DENTECH CO LTD SUE RU
K131395 05/15/2013 TRANSTEK BLOOD PRESSURE MONITOR GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD LEO WANG
K131394 05/15/2013 TRANSTEK GLASS BODY FAT ANALYZER GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD LEO WANG
K131232 05/01/2013 WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) Guangzhou Wondfo Biotech Co., Ltd. Joe Shia
K131494 05/23/2013 HEART SYNC HEART SYNC INC. DANIEL KAMM
K131550 05/29/2013 HEART SYNC HEART SYNC INC. DANIEL KAMM
K131440 05/20/2013 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD CHARLES SHEN
K131479 05/22/2013 V8 SP NORMAL CONTROL, ABNORMAL CONTROL HELENA LABORATORIES JUSTIN PADIA
K131233 05/01/2013 HERMES MEDICAL IMAGING SUITE V5.3 HERMES MEDICAL SOLUTIONS, AB JOAKIM ARWIDSON
K131424 05/17/2013 MIPLATFORM MEDICAL IMAGING SUITE HINACOM SOFTWARE AND TECHNOLOGY, LTD. YI ISABELLE SUN
K131581 05/31/2013 MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK) HOLOGIC, INC. SARAH FAIRFIELD
K131463 05/21/2013 WRIST AUTOMATIC BLOOD PRESSURE MONITOR HONSUN (NANTONG) CO., LTD SELINA QIAN
K131249 05/01/2013 ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES I-FLOW LLC SHELLY HARRIS
K131419 05/16/2013 ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM i-SENS, Inc. CHAE YUN LIM
K131309 05/07/2013 SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ IBRAMED EQUIPAMENTOS MEDICOS TARA CONRAD
K131279 05/06/2013 ICONACY I-HIP SYSTEM ICONACY ORTHOPEDIC IMPLANTS, LLC MARC E RUHLING
K131549 05/29/2013 CHEMOLOCK, CHEMOLOCK PORT ICU MEDICAL INC KATHERINE KENNER
K131245 05/01/2013 OREGON SCINTIFIC IDT TECHNOLOGY LIMITED LILY LI
K131348 05/10/2013 ORTOMED INFOMED SERVICIOS INFORMATICOS S.L. SANTIAGO SOLA
K131277 05/06/2013 SEVIIN FRACTURE SHOULDER INGEN ORTHOPEDICS LLC PERRY A GEREMAKIS
K131362 05/13/2013 INMODE WMBODY DEVICE INMODE MD LTD. AHAVA STEIN
K131304 05/07/2013 SENTIO MMG INNOVATIVE SURGICAL SOLUTIONS, LLC ("ISS") AASHISH SHAH
K131294 05/06/2013 OMNIPOD INSULIN MANAGEMENT SYSTEM INSULET CORPORATION TARA N TURNEY
K131446 05/20/2013 INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES INTEGRA LIFESCIENCES CORPORATION STEPHANIE N SHEESLEY
K131585 05/31/2013 INTEL-GE CARE INNOVATIONS QUIETCARE INTEL-GE CARE INNOVATIONS LLC MAUREEN GLYNN
K131584 05/31/2013 IMDX FLU A/B AND RSV FOR ABBOTT M2000 INTELLIGENT MEDICAL DEVICES, INC FRAN WHITE
K131382 05/14/2013 EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL INVIVO CORPORATION RUSTY KELLY
K131282 05/06/2013 NEXUS HEMORRHOID LIGATOR INX MEDICAL PAUL DRYDEN
K131290 05/06/2013 IQ TECHNOLOGIES IQ TECHNOLOGIES INC. ELI JOSEF
K131285 05/06/2013 SONOSENTRY ISONEA LTD KORINA AKHONDZADEH
K131433 05/17/2013 ISYS 1 (U.S),ACCESSORY, NON-STERILE ISYS MEDIZINTECHNIK GMBH CORNELIA DAMSKY
K131487 05/23/2013 FLUOR PROTECTOR S IVOCLAR VIVADENT AG DONNA M HARTNETT
K131336 05/09/2013 TX WHEELCHAIR CHASSIS JCM SEATING SOLUTIONS LTD STUART R GOLDMAN
K131311 05/07/2013 ARIX FOOT SYSTEM JEIL MEDICAL CORPORATION JI-EUN KIM
K131566 05/30/2013 ARIX HAND SYSTEM JEIL MEDICAL CORPORATION JI-EUN KIM
K131411 05/15/2013 COSEAL JILIN CORONADO MEDICAL LTD. ERIC CHIEN
K131291 05/06/2013 TORC BODY JOHARI DIGITAL HEALTHCARE, LTD. POOJA JOHARI
K131533 05/25/2013 CAYMAN MI PLATE SYSTEM K2M, INC. NANCY GIEZEN
K131364 05/13/2013 FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE KARL STORZ ENDOSCOPY-AMERICA, INC. SHIVEN GANDHI
K131369 05/13/2013 FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC. LEIGH SPOTTEN
K131589 05/31/2013 KEELER SLIT LAMP H-SERIES KEELER LTD. NICKIE POWER
K131384 05/14/2013 KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE KERICURE INC. JONATHAN WARD
K131254 05/02/2013 KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE KIMBERLY-CLARK CORP. MARCIA JOHNSON
K131491 05/23/2013 KITAZATO IUI CATHETER KITAZATO MEDICAL CO., LTD. RICHARD VINCINS, CBA, CQA, RAC
K131448 05/20/2013 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION KOELIS LAETITIA GERVAIS
K131430 05/17/2013 CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL KURARAY NORITAKE DENTAL INC. MICHIO TAKIGAWA
K131432 05/17/2013 CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND; CLEARFIL KURARAY NORITAKE DENTAL INC. MICHIO TAKIGAWA
K131534 05/29/2013 KATANA ZIRCONIA KURARAY NORITAKE DENTAL INC. IVAN WASSERMAN
K131547 05/29/2013 LANX FUSION SYSTEM LANX, INC. Alan Burkholder
K131568 05/30/2013 SUDO PATH LD TECHNOLOGY LLC ALBERT MAAREK
K131461 05/20/2013 LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI LED INTELLECTUAL PROPERTIES, LLC STEVE MARCHESE
K131565 05/30/2013 XTAG CYP2C19 KIT V3 LUMINEX MOLECULAR DIAGNOSTICS, INC. Ronald Dunn
K131340 05/09/2013 POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES MADE PLASTIC CO., LTD. CHU XIAOAN
K131559 05/30/2013 MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES MATERIALISE N.V. Alexandra Razzhivina
K131481 05/22/2013 FREEDOM PCK COMPONENTS MAXX ORTHOPEDICS, INC. NACH DAVE
K131497 05/24/2013 MCKESSON CARDIOLOGY HEMO MCKESSON ISRAEL LTD. PAUL SUMNER
K131310 05/07/2013 GMK FULL PE TIBIAL COMPONENTS MEDACTA INTERNATIONAL ADAM GROSS
K131518 05/28/2013 MECTACER BIOLOX OPTION HEADS MEDACTA INTERNATIONAL ADAM GROSS
K131458 05/20/2013 MPACT DM LINER CONVERTER MEDACTA INTERNATIONAL ADAM GROSS
K131339 05/09/2013 CAPNOMASK MEDIPLUS LTD. PAUL DRYDEN
K131426 05/17/2013 MEDLINE BIOPSY VALVE MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K131517 05/28/2013 MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING MEDRAD, INC. / BAYER MEDICAL CARE, INC. LISA A EWING
K131555 05/29/2013 MEDSOURCE IV SAFETY CATHETER MEDSOURCE INTERNATIONAL, LLC. JENNIFER NESS
K131425 05/17/2013 NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER MEDTRONIC NAVIGATION, INC. REGINA HOLMES
K131321 05/08/2013 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA LAUREN KAMER
K131269 05/03/2013 DLP CORONARY OSTIAL PERFUSION CANNULAE MEDTRONIC, INC. KEVIN T LAM
K131272 05/03/2013 SIREN EPCR SUITE MEDUSA MEDICAL TECHNOLOGIES INC. DIANE SUDDUTH
K131289 05/06/2013 I-GEN MEGAGEN IMPLANT CO., LTD APRIL LEE
K131420 05/16/2013 PETITE BASIC SYSTEM 701 ELT MEGO AFEK AC LTD MARIA GRIFFIN
K131401 05/15/2013 BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER MERCATOR MEDSYSTEMS, INC. PLAMENA ENTCHEVA-DIMITROV, PHD
K131247 05/01/2013 MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM MFS - MEDICAL FLOW SYSTEMS LTD OFER SHAY
K131482 05/23/2013 SOFIA DISTAL ACCESS CATHETER MICRO VENTION, INC. Naomi Gong
K131346 05/09/2013 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K131416 05/16/2013 NOVOPRESS MILKA, LLC JONATHAN KAHAN
K131431 05/17/2013 AIRO CT SYSTEM MOBIUS IMAGING, LLC NORMA LEMAY
DEN130004 05/06/2013 MOERAE SURGICAL MARKING PEN MOERAE MATRIX, INC. ROBERT J CHIN
K131278 05/06/2013 MONTERIS MEDICAL NEUROBLATE SYSTEM MONTERIS MEDICAL, INC. CRAIG COOMBS
K131375 05/13/2013 AUTOLAP SYSTEM MST - MEDICAL SURGERY TECHNOLOGIES LTD. John j Smith, M.D., J.D.
K131578 05/31/2013 IPROPHY MOBILE NAKANISHI, INC. DIANE RUTHERFORD
K131389 05/14/2013 JUSHA-C31 MEDICAL DISPLAY NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD MIKE GU
K131391 05/14/2013 JUSHA-M32 MEDICAL DISPLAY NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD MIKE GU
K131390 05/14/2013 JUSHA-M52C MEDICAL DISPLAY NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD MIKE GU
K131345 05/09/2013 TIARRAY DENTAL IMPLANT SYSTEM NASSEO, INC. Allison C Komiyama
K131260 05/02/2013 NMI DIALYSIS CATHETER NAVILYST MEDICAL, INC. Lorraine M Hanley
K131471 05/22/2013 SELF-COMPRESSIVE SCREW NEOSTEO JD WEBB
K131374 05/13/2013 TEMPUS(TM) CERVICAL PLATE SYSTEM NEUROSTRUCTURES, LLC MEREDITH MAY
K131415 05/16/2013 LIVE VIEW PANEL (LVP) NEUROTRONICS, INC. DAVID PEZET
K131335 05/09/2013 BWMINI EEG, BWMINIHST, BWMINI PSG NEUROVIRTUAL USA, INC. EDUARDO FARIA
K131417 05/16/2013 FACET FIXX NEXXT SPINE LLC KAREN E WARDEN PHD
K131381 05/14/2013 ELISIO-H HEMODIALYZER NIPRO MEDICAL CORPORATION CAROLYN GEORGE
K131509 05/24/2013 ZOE FLUID STATUS MONITOR NONINVASIVE MEDICAL TECHNOLOGIES, INC. MARC O'GRIOFA
K131542 05/29/2013 NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC Novabay Pharmaceuticals, Inc PATSY J TRISLER
K131398 05/15/2013 NOVOKNEE TOTAL KNEE SYSTEM NOVOSOURCE INC JAMES PINKSTON
K131238 05/01/2013 AFFIX SPINOUS PROCESS PLATE SYSTEM NUVASIVE, INC. Sheila Bruschi
K131472 05/22/2013 APEX KNEE MODULAR TIBIA SYSTEM OMNI LIFE SCIENCE, INC. BRANDON MOLINA
K131563 05/30/2013 SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM OPUS KSD, INC. ROSINA ROBINSON, RN, MED, RAC
K131337 05/09/2013 BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA ORTHO DEVELOPMENT CORP. TOM HAUETER
K131324 05/08/2013 MAXTORQUE SCREW SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. BRIAN HOCKETT
K131409 05/15/2013 CAS PSI KNEE SYSTEM ORTHOSOFT, INC. CHRISTOPHER MCLEAN
K131478 05/22/2013 CONTRAST CONSERVATION SYSTEM OSPREY MEDICAL, INC. JILL MUNSINGER
K131445 05/20/2013 OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM OSTEOMED LP BLESSON ABRAHAM
K131450 05/20/2013 FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0 OSTIAL CORPORATION JAKE WOLENBERG
K131586 05/31/2013 CANCARY BREATHING SYSTEM PALO ALTO HEALTH SCIENCES, INC. LORI ADELS, PHD
K131451 05/20/2013 PALTOP DENTAL IMPLANT - STERILE ACCESSORIES PALTOP ADVANCED DENTAL SOLUTIONS LTD TAL HAMMER-TOPAZ
K131591 05/31/2013 FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE) PEGA MEDICAL INC. ARIEL R DUJOVNE
K131253 05/02/2013 PERIFLUX 6000 PERIMED AB MARIA LILJEVRET
K131590 05/31/2013 INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE PHILIPS MEDICAL SYSTEMS CHRISTINE TREFETHEN
K131483 05/23/2013 PHILIPS PIXIUM 4343RC PHILIPS MEDICAL SYSTEMS DMC GMBH JENNIFER CARTLEDGE
K131241 05/01/2013 SWIP PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. SUSAN QUICK
K131263 05/03/2013 XPERGUIDE PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. JOS V VROONHOVEN
K131529 05/28/2013 SHENGGUANG MANUAL WHEELCHAIR PINGDINGSHAN SHENXING HEALTHCARE TECHNOLOGY CO., L WANG QING
K131368 05/13/2013 NEO KNEE SYSTEM PIPELINE ORTHOPEDICS TERRY POWELL
K131237 05/01/2013 PIPELINE TOTAL HIP SYSTEM PIPELINE ORTHOPEDICS TERRY POWELL
K131543 05/29/2013 TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED PROCTER & GAMBLE CO. KATHLEEN BLIESZNER
K131524 05/28/2013 PROTEUS PATCH INCLUDING INGESTIBLE SENSOR PROTEUS DIGITAL HEALTH, INC. ZAHEDEH HATAMKHANY
K131473 05/22/2013 (QUANTA SYSTEM) SURGICAL LASER FIBERS QUANTA SYSTEM, S.P.A. Maurizio Bianchi
K131329 05/08/2013 VECTOR PTA BALLOON DILATATION CATHETER R4 VASCULAR, INC. LAURIE LEWANDOWSKI
K131554 05/30/2013 RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K131429 05/17/2013 RELIANCE CERVICAL IBF SYSTEM Reliance Medical Systems, LLC Bret M Berry
K131354 05/10/2013 RENOVIS BIPOLAR HIP SYSTEM RENOVIS SURGICAL TECHNOLOGIES LLC Sharyn Orton
K131455 05/20/2013 RESTORE MODULAR STERILIZATION TRAY SYSTEM RESTORE MEDICAL SOLUTIONS, INC. PATSY J TRISLER
K131287 05/06/2013 CARDIOSLEEVE RIJUVEN CORP E.J. Smith
K131513 05/28/2013 SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY RITM OKB ZAO LARISA SHPUNGINA
K131557 05/29/2013 RITTER IMPLANT SYSTEM RITTER IMPLANTS GMBH CO KG RAYMOND KELLY
K131544 05/29/2013 COBAS C BILIRUBIN TOTAL GEN.3 Roche Diagnostics LISA K KLINEDINST
K131244 05/01/2013 ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET Roche Diagnostics EDIE EADS
K131366 05/13/2013 ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM ROCHE DIAGNOSTICS OPERATIONS INC NATHAN CARRINGTON
K131561 05/30/2013 SAM JUNCTIONAL TOURNIQUET SAM MEDICAL PRODUCTS JACK N MCCUTCHEON
K131355 05/10/2013 CONCEIVE PLUS SASMAR INC JOHN-MICHAEL MANCINI
K131502 05/24/2013 SEATTLE - PAP SEATTLE CHILDRENS HOSPITAL PAUL DRYDEN
K131582 05/31/2013 SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM SENSUS HEALTHCARE KAL FISHMAN
K131512 05/28/2013 KATIA SYSTEM SHANGHAI SANYOU MEDICAL CO, LTD KIMBERLY STROHKIRCH
K131259 05/02/2013 LASER-STIM SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. JIANGPING KANG
K131457 05/20/2013 FETAL ULTRASONIC MONITOR AND ACCESSORIES SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD FIELD FU
K131243 05/01/2013 NON-CONTACT INFRARED THERMOMETER SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD FIELD FU
K131569 05/30/2013 PG-800A SERIES SHENZHEN PANGO ELECTRONIC CO., LTD Diana Hong
K131558 05/30/2013 PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6 SHENZHEN PANGO ELECTRONIC CO., LTD XIAOYUN YANG
K131344 05/09/2013 POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG WALLY PLASTICS CO., LTD CHU XIAOAN
K131341 05/09/2013 POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG WINFUL PLASTIC CO., LTD. CHU XIAOAN
K131504 05/24/2013 UNIVERSAL OPAQUE SHOFU DENTAL CORPORATION DAVID P MORAIS
K131405 05/15/2013 IFUSE IMPLANT SYSTEM SI-BONE, INC. CINDY DOMECUS
K131536 05/29/2013 IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL Siemens Healthcare Diagnostics Inc. Garo Mimaryan
K131307 05/07/2013 ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR SIEMENS HEALTHCARE DIAGNOSTICS, INC. KIRA GORDON
K131275 05/03/2013 MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS SIEMENS HELATHCARE DIAGNOSTICS INC. ELISABETH WARINER
K131372 05/13/2013 MOBIS II SIGNUS MEDIZINTECHNIK GMBH KAREN E WARDEN
K131319 05/07/2013 T1/T2/T3 TURBINE FAMILY SIRONA DENTAL SYSTEMS GMBH FRITZ KOLLE
K131388 05/14/2013 TRANSCEND HEATED HUMIDIFIER SOMNETICS INTERNATIONAL, INC. MELINDA SWANSON
K131262 05/03/2013 DIGITAL ELECTROCARDIOGRAPHS SONOSCAPE COMPANY LIMITED Diana Hong
K131553 05/30/2013 XTRA SORIN GROUP DEUTSCHLAND GMBH BARRY SALL, RAC, FRAPS
K131410 05/15/2013 CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE), SOUTHMEDIC, INC. TISH ANGER
K131427 05/17/2013 LOTUS SPINAL ELEMENTS, INC. BENJAMIN A KIMBALL
K131343 05/09/2013 REFORM PEDICLE SCREW SYSTEM SPINAL USA MEREDITH MAY
K131521 05/28/2013 VELOX ANTERIOR CERVICAL PLATE SYSTEM SPINECRAFT LLC AMI AKALLAL-ASAAD
K131452 05/20/2013 PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300 ST. JUDE MEDICAL SYSTEMS AB ERDULFO DE PERALTA
K131444 05/20/2013 UA-CELLULAR COMPLETE Streck Deborah Kipp
K131365 05/13/2013 T2 TIBIAL NAILING SYSTEM Stryker Trauma AG ESTELA CELI
K131466 05/21/2013 MAPCHECK2, ARCCHECK SUN NUCLEAR CORPORATION JEFF KAPATOES
K131314 05/07/2013 DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM) SWISSRAY MEDICAL AG TODD SHOPP
K131276 05/06/2013 LATERAL SYNFIX SYNTHES (USA) PRODUCTS LLC MONIKA MCDOLE-RUSSELL
K131548 05/30/2013 SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM SYNTHES (USA) PRODUCTS, LLC HEMAL MEHTA
K131286 05/06/2013 PRIMATRIX DERMAL REPAIR SCAFFOLD TEI BIOSCIENCES INC. KENNETH JAMES
K131447 05/20/2013 INTUITION - TDA, TVA, PARAMETRIC MAPPING TERARECON, INC. EMILLY T NURTHEN
K131583 05/31/2013 THERMOCHEM HT-2000 THERMASOLUTIONS, INC. M.W. ANDY ANDERSON PH.D. RAC
K131507 05/24/2013 XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM TOSHIBA MEDICAL SYSTEMS CORPORATION CHARLEMAGNE CHUA
K131580 05/31/2013 AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8 Tosoh BioScience, Inc. ROBERT L WICK
K131454 05/20/2013 KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEAD TOTAL JOINT ORTHOPEDICS, INC. JEAN M WHEELER
K131489 05/23/2013 TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION TRACTUS CORPORATION MARK JOB
K131236 05/01/2013 UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP UCP BIOSCIENCES, INC. NANCY CHEN
K131357 05/10/2013 PEAK Z ULTRADENT PRODUCTS, INC. DIANE ROGERS
K131540 05/29/2013 INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE VERTEBRAL TECHNOLOGIES, INC. SURESH GHAI
K131567 05/30/2013 ALADDIN VISIA imaging S.r.l. Claude Berthoin
K131434 05/17/2013 VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM VISIONSENSE, LTD. GERARD J PRUD'HOMME
K131288 05/06/2013 VERRATA PRESSURE GUIDE WIRE VOLCANO CORPORATION JWALA JAWHARKAR
K131284 05/06/2013 GSP NEONATAL BIOTINIDASE KIT WALLAC OY JEANETTE SCHIER-PUGSLEY
K131573 05/30/2013 CP150 ELECTROCARDIOGRAPH WELCH ALLYN, INC. KEVIN CROSSEN
K131296 05/06/2013 VARILIFT-L INTERBODY FUSION DEVICE WENZEL SPINE, INC. SANDIE ROTH
K131283 05/06/2013 PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES WRIGHT MEDICAL TECHNOLOGY, INC. Danielle Mueller
K131387 05/14/2013 WRIGHT GRADIENT 52 - TORSO WRIGHT THERAPY PRODUCTS, INC CAROL WRIGHT
K131373 05/13/2013 SHANGRING WUHU SNNDA MEDICAL TREATMENT APPLIANCE TECHNOLOGY BO GONG
K131350 05/10/2013 CALIX LUMBAR SPINAL IMPLANT SYSTEM X-SPINE SYSTEMS, INC DAVID KIRSCHMAN
K131242 05/01/2013 ARDIS INTERBODY SYSTEM ZIMMER SPINE, INC JON GILBERT
K131413 05/16/2013 XTRAFIX SMALL EXTERNAL FIXATION SYSTEM ZIMMER, INC.


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