FDA 510(k) Decisions During November, 2013  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K132712 11/19/2013 AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER MEDTRONIC INC. LISA STONE
K131782 11/18/2013 LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5 AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K131753 11/14/2013 MERIDIAN AB ARDENT DONNA MARIE HARTNETT
K131383 11/27/2013 X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE ADVANCED BRAIN MONITORING INC. ADRIENNE LENZ
K132561 11/05/2013 NURO NEUROMODULATION SYSTEM ADVANCED URO-SOLUTIONS, INC. PENNY NORTHCUTT
K132821 11/20/2013 AGAMATRIX HEALTH MANAGER AGAMATRIX INC WILLIAM H MCGRAIL
K131165 11/14/2013 ANKER DENTAL IMPLANT SYSTEM ALLIANCE GLOBAL YAYUAN CHANG
K132687 11/27/2013 E-CUBE 7 ALPINION MEDICAL SYSTEMS CO., LTD DONGHWAN KIM
K130845 11/01/2013 AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW AMBU A/S SANJAY PARIKH
K132655 11/20/2013 RETROARC RETROPUBIC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC. RENEE MELLUM
K131904 11/13/2013 MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA AMERIWATER BRIAN R BOWMAN
K130730 11/22/2013 V-STICK VASCULAR ACCESS SET ARGON MEDICAL JENNIFER BONACCI
K132217 11/25/2013 ARTHREX COMPRESSION FT SCREWS ARTHREX, INC. COURTNEY SMITH
K131377 11/19/2013 HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT ARTHROSURFACE, INC. DAWN J WILSON
K130514 11/21/2013 AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT AUDIFON-USA INC. JANE E PERRONE
K133091 11/27/2013 ZIP MIS INTERSPINOUS FUSION SYSTEM AURORA SPINE JUSTIN EGGLETON
K133008 11/20/2013 BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED, BEACON ENDOSCOPIC ANNETTE M FAGNANT
K133138 11/13/2013 BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B BECTON DICKINSON & CO. GREGORY P PAYNE
K133140 11/15/2013 BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV BECTON DICKINSON & CO. GREGORY P PAYNE
K132456 11/07/2013 BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV BECTON, DICKINSON AND COMPANY GREGORY P PAYNE, RAC
K132102 11/12/2013 BECE CAD ZIRKON HT+ BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO HEIKE GUSTKE
K131423 11/07/2013 G-ARM MULTISCAN SYSTEM BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD. BETTER LI
K131519 11/06/2013 BELMONT HYPERTHERMIA PUMP BELMONT INSTRUMENT CORP. SABRINA BELLADUE
K132507 11/15/2013 VITEK 2 AST ST MEROPENEM BIOMERIEUX, INC. NATHAN HARDESTY
K132898 11/19/2013 A.L.P.S. CALCANEAL PLATING SYSTEM BIOMET MANUFACTURING CORP. JARED COOPER
K130322 11/15/2013 SPM-300 BIONET CO., LTD. MARC GOODMAN
K130777 11/25/2013 INBODY BIOSPACE CORPORATION LIMITED DANIEL KAMM, P.E.
K133208 11/14/2013 INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM BOSTON SCIENTIFIC CORP. MAUREEN SUNDEEN
K131700 11/04/2013 SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES BOSTON SCIENTIFIC CORP. JANIS F TARANTO
K130831 11/21/2013 MALDI BIOTYPER CA (MBT-CA) SYSTEM BRUKER DALTONICS, INC FRAN WHITE
K130101 11/08/2013 BYTECH BYTECH DONGTAI CO., LTD. CHU XIAOAN
K131689 11/20/2013 MRI MARKER C4 IMAGING LLC STEPHEN J GOLDNER, JD, RAC
K133399 11/22/2013 DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM CARDIOVASCULAR SYSTEMS INCORPORATED BLAIR BUTH
K122400 11/05/2013 CARDIOX FLOW DETECTION SYSTEM CARDIOX CORP. KAREN MATIS
K122490 11/13/2013 KULAVAC CGBIO CO., LTD JUNGEUN IM
K133357 11/25/2013 CHARRUAPACS SYSTEM CHARRUASOFT SA CARL ALLETTO
K121587 11/22/2013 BREATH SHAKE CHEEN HOUNG ENT. CO. LTD. PAUL DRYDEN
K130853 11/13/2013 IDYS(TM) C CLARIANCE JANICE M HOGAN
K132799 11/07/2013 CLARISO PACS CLARISO, INC. CARL ALLETTO
K132085 11/12/2013 ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM CO-INNOVATION BIOTECH CO., LTD. HONG FENG
K131240 11/07/2013 COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT COCHLEAR AMERICAS SEAN BUNDY
K131998 11/26/2013 ASPIRE RX-LP6 ASPIRATION CATHETER CONTROL MEDICAL TECHNOLOGY, LLC SHAWN FOJTIK
K132307 11/05/2013 VIDA LED SURGICAL LIGHTING SYSTEM CONVIDA HEALTHCARE & SYSTEMS CORPORATION RYAN HUNG
K132504 11/25/2013 TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM CORELINK LLC JUSTIN EGGLETON
K132567 11/05/2013 ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN COVIDIEN DOLLY MISTRY
K130357 11/06/2013 SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH COVIDIEN LLC KRISTEN SWANSON
K132795 11/26/2013 CYBERWAND STERILE PROBE SET CYBERSONICS, INC. LORI COLVIN
K131850 11/15/2013 TENSYN BAND DALLEN MEDICAL, INC. AL MEMMOLO
K130135 11/25/2013 DANA REUSABLE BI TEST PACK DANA PRODUCTS, INC. HARRY BALA
K131839 11/07/2013 DC 7 DC INTERNATIONAL, LLC DAVID BOEGLER
K132241 11/05/2013 GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK ANCHOR W/ PROKNOT T DEPUY MITEK, A JOHNSON & JOHNSON COMPANY YAYORI FUJIMAKI
K132515 11/08/2013 LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS DIASORIN, INC. CAROL A DEPOUW
K131302 11/26/2013 SOLAX DONGGUAN PRESTIGE SPORTING GOODS CO., LTD. JUNNATA CHANG
K132443 11/22/2013 PIEZON 150 E.M.S. ELECTRO MEDICAL SYSTEMS S.A. CYNTHIA NOLTE
K131819 11/22/2013 PC ECG EDAN INSTRUMENTS, INC. QUEENA CHEN
K132231 11/27/2013 MYLABSEVEN, MYLABALPHA ESAOTE, S.P.A. ALLISON SCOTT
K131298 11/26/2013 EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM EXACTECH, INC. SHING JEN TAI, PHD
K133102 11/18/2013 FLOWER ANKLE PLATING SET FLOWER ORTHOPEDICS CORPORATION JANICE M HOGAN
K132509 11/25/2013 FDR D-EVO FLAT PANEL DETECTOR SYSTEM FUJIFILM MEDICAL SYSTEMS USA, INC. KATHERINE Y CHOI
K133134 11/04/2013 X-PORTE ULTRASOUND SYSTEM FUJIFILM SONOSITE,INC. SCOTT PAULSON
K130759 11/09/2013 HUMELOCK II CEMENTLESS SHOULDER SYSTEM FX SOLUTIONS JEAN-JACQUES MARTIN
K132913 11/08/2013 VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10 GE HEALTHCARE BRYAN BEHN
K132376 11/15/2013 DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC) MICHELLE HUETTNER
K132261 11/18/2013 DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) GE MEDICAL SYSTEMS, LLC JOHN L SCHMIDT
K132822 11/26/2013 BD MAX STAPHSR ASSAY, INSTRUMENT GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) PATRICIA DIONNE
K123090 11/22/2013 GLB BENECHECK PREMIUM GLU MONITORING SYSTEM GENERAL LIFE BIOTECHNOLOGY CO., LTD. FENG-YU LEE
K131142 11/27/2013 GENESIS LED WANDS GENESIS BIOSYSTEMS, INC. JIM LAFFERTY
K130419 11/06/2013 PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM GENORAY CO., LTD. JAE KIM
K132191 11/22/2013 SP-FIX SPINOUS PROCESS FIXATION PLATE GLOBE MEDICAL, INC. CHRISTINA KICHULA
K130997 11/15/2013 NEOVEIL GUNZE LIMITED NOBUYA ONISHI
K122438 11/20/2013 HAMILTON-MR1 HAMILTON MEDICAL AG RALPH AGUILA
K132006 11/07/2013 STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU) HARTALEGA SDN BHD NURUL AISYAH KONG
K132883 11/01/2013 HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) HEMODIA S.A.S. REMI TEULIERE
K132276 11/12/2013 STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML HOSPIRA, INC. ABIGAIL FERGUSON
K132288 11/22/2013 CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER I-SENS, INC. CHAE YUN LIM
K131629 11/26/2013 NEURODYN MULTIWAVE, AUSSIE SPORT IBRAMED EQUIPAMENTOS MEDICOS LILIAN LLULL
K132893 11/20/2013 EDGE ORTHOPAEDICS BITE COMPRESSION SCREW ICON ORTHOPAEDIC CONCEPTS DBA EDGE ORTHOPAEDICS JAN TRIANI
K124006 11/19/2013 ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY ILLUMINA, INC. LEANNE M KIVIHARJU
K132750 11/19/2013 ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY ILLUMINA, INC. BRYAN SCHNEIDER
DEN130011 11/19/2013 ILLUMINA MISEQDX PLATFORM ILLUMINA, INC. LEANNE M KIVIHARJU
K123989 11/19/2013 ILLUMINA MISEQDX PLATFORM ILLUMINA, INC. LEANNE M KIVIHARJU
DEN130042 11/19/2013 MISEQDX UNIVERSAL KIT 1.0 ILLUMINA, INC. LEANNE M KIVIHARJU
K133136 11/19/2013 MISEQDX UNIVERSAL KIT 1.0 ILLUMINA, INC. LEANNE M KIVIHARJU
K132971 11/20/2013 MONACO IMPAC MEDICAL SYSTEMS, INC. KATHRYN STINSON
K133031 11/15/2013 SHARPSOLOGY 2 INDUSTRIAL WATER SOLUTIONS, INC. THOMAS P STEWART
K131661 11/05/2013 INFUSION SYRINGE SET INNOVATIVE MEDICAL MANUFACTURING CO. LUCY HUANG
K131686 11/29/2013 INOMAX DSIR (DELIVERY SYSTEM) INO THERAPEUTICS/IKARIA ROBERT BOVY
K132718 11/18/2013 INTEGRITY SPINE CORE SYSTEM INTEGRITY SPINE LISA PETERSON
K132347 11/20/2013 MULTICAM 3000 ECO INTER MEDICAL MEDIZINTECHNIK GMBH WILLIAM CARROLL
K132728 11/22/2013 V8 TRANSLUMINAL BAV CATHETER INTERVALVE, INC SEW-WAH TAY
K132847 11/20/2013 I2C ION BEAM APPLICATIONS S.A. BRUCE D ARMON
K130856 11/25/2013 BIA / VITALITY ANALYZER IPGDX, LLC KEVIN WALLS
K130829 11/14/2013 IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTS IQ IMPLANTS LTD. NATALIA DINERSTHEIN
K130707 11/20/2013 ISIRONA MAGELLAN ISIRONA, LLC THOMAS KROENKE
K131566 11/04/2013 ARIX HAND SYSTEM JEIL MEDICAL CORPORATION JI-EUN KIM
K131828 11/26/2013 POWDER FREE VINYL PATIENT EXAMINATION GLVOES, LIGHT YELLOW COLOR JIANGSU HANDSAFE GLOVE CO., LTD. CHU XIAOAN
K131831 11/26/2013 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR JIANGSU HEALTHCARE PRODUCTS CO., LTD. CHU XIAOAN
K131826 11/22/2013 TOPTOUCH /OTHER CLIENTS PRIVATE LABELING JIANGSU TOPTOUCH GLOVE CO., LTD. CHU XIAOAN
K122061 11/08/2013 K-Y BRAND LIQUIBEADS JOHNSON & JOHNSON HEALTHCARE PRODUCTS LORNA-JANE BREMER
K131533 11/09/2013 CAYMAN MI PLATE SYSTEM K2M, INC. NANCY GIEZEN
K132757 11/20/2013 EVEREST SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K132597 11/25/2013 BLACK COLOURED CONDOM KAREX INDUSTRIES SDN BHD MARY GOH YIN
K131369 11/26/2013 FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC. LEIGH SPOTTEN
K133276 11/19/2013 V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS KCI USA, INC. MELANIE AVILA
K132741 11/15/2013 V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM KCI USA, INC. MELANIE AVILA
K131841 11/07/2013 KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE KIMBERLY-CLARK CORP. CHRISTINE L MACAULEY
K132124 11/01/2013 KLARITY VACUUM BAG, KLARITY MOLD CUSHION KLARITY MEDICAL PRODUCTS, LLC PETER LARSON
K132450 11/01/2013 CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND KURARAY NORITAKE DENTAL INC. MICHIO TAKIGAWA
K132022 11/06/2013 LEMAITRE 8F OCCLUSION CATHETER LEMAITRE VASCULAR, INC. ANDREW HODGKINSON
K132047 11/05/2013 LEMILLS VALVULOTOME LEMAITRE VASCULAR, INC. ANDREW HODGKINSON
K130195 11/01/2013 SCANNING LASERLINK LUMENIS, INC. JACE R MCLANE
K130199 11/22/2013 CLARITY LPC LASER SYSTEM LUTRONIC CORPORATION JHUNG WON VOJIR
K133265 11/12/2013 QUADROX-IR ADULT AND SMALL ADULT MAQUET CARDIOPULMONARY AG WHITNEY TORNING
K131778 11/14/2013 FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT MAQUET CARDIOVASCULAR LLC MARYLOU INSINGA
K132605 11/14/2013 DOSIMETRY CHECK VERSION 4 RELEASE 1 MATH RESOLUTIONS, LLC. WENDEL DEAN RENNER
K132848 11/29/2013 PIEZOSURGERY FLEX MECTRON S.P.A. ROGER GRAY
K131518 11/04/2013 MECTACER BIOLOX OPTION HEADS MEDACTA INTERNATIONAL ADAM GROSS
K132498 11/25/2013 VALVED TEARAWAY INTRODUCER GENERATION II MEDCOMP (MEDICAL COMPONENTS, INC.) TIMOTHY HOLWICK
K122252 11/13/2013 SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS MEDICAL DEVELOPMENTS INTERNATIONAL TRACEY BULLIVANT
K132574 11/08/2013 PASS LP SPINAL SYSTEM MEDICREA INTERNATIONAL AUDREY VION
K131339 11/25/2013 CAPNOMASK MEDIPLUS LTD. PAUL DRYDEN
K122410 11/12/2013 I RUNE (I-200L) MEDIRUNE CO, LTD YANG HO DONG
K132545 11/08/2013 MEDIVALVE ACWIRE MEDIVALVE LTD. LEO BASTA
K132639 11/25/2013 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. SHWETA SHARMA
K131669 11/01/2013 PERIMETER INTERBODY FUSION DEVICE MEDTRONIC SOFAMOR DANEK USA, INC. LAUREN KAMER
K133216 11/22/2013 CRESCENT SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. ANKIT K SHAH
K132297 11/05/2013 EM SINUS DILATION SYSTEM MEDTRONIC XOMED, INC. ROZANNE PACIEJ
K131699 11/26/2013 EMOTION ECG MOBILE MEGA ELECTRONICS LTD. ANDRE KINDSVATER
K131420 11/01/2013 PETITE BASIC SYSTEM 701 ELT MEGO AFEK AC LTD MARIA GRIFFIN
K132155 11/07/2013 ASAPLP ASPIRATION CATHETER MERIT MEDICAL SYSTEMS, INC. SUSAN CHRISTENSEN
K131482 11/22/2013 SOFIA DISTAL ACCESS CATHETER MICRO VENTION, INC. NAOMI GONG
K131016 11/27/2013 ROGS MOLECULAR PRODUCTS LTD. PAUL DRYDEN
K132048 11/06/2013 BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET MOLNLYCKE HEALTH CARE US, LLC CURTIS D TRUESDALE
K131390 11/27/2013 JUSHA-M52C MEDICAL DISPLAY NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD MIKE GU
K133264 11/20/2013 NMI PICC III NAVILYST MEDICAL, INC. BRANDON BRACKETT
K130565 11/27/2013 SPECULAR MICROSCOPE CEM-530 NIDEK CO., LTD. ARON SHAPIRO
K133061 11/27/2013 ESPIN SYSTEM NLT SPINE LTD JOHN J SMITH
K130368 11/15/2013 AUTOLITH TOUCH; URO TOUCH NORTHGATE TECHNOLOGIES INC. CASEY KUREK
K131025 11/27/2013 ARCHON ANTERIOR CERVICAL PLATE SYSTEM NUVASIVE, INC. CYNTHIA ADAMS
K132411 11/20/2013 AFFIX II SPINOUS PROCESS PLATE SYSTEM NUVASIVE, INCORPORATED OLGA LEWIS
K131672 11/15/2013 MICROCYN SCAR MANAGEMENT HYDROGEL OCULUS INNOVATIVE SCIENCES BRIAN W MARTIN
K131211 11/05/2013 DICOMPACS DX-R WITH FLAT PANEL OEHM UND REHBEIN GMBH FRANZISKA GUENTHER
K131128 11/13/2013 OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES OMEGA LABORATORIES, INC. ROBERT J BARD, JD
K130387 11/08/2013 ORTHOALIGN PLUS SYSTEM ORTHALIGN, INC AMY WALTERS
K131767 11/08/2013 ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM ORTHOSENSOR, INC. MARTHA I GARAY
K123148 11/19/2013 PARACE MD EKOSCOPE IS100 PARACE LLC VANDETTE CARTER
K131591 11/27/2013 FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE) PEGA MEDICAL INC. ARIEL R DUJOVNE
K132614 11/14/2013 PEREGRINE CURVED ILLUMINATING LASER PROBE PEREGRINE SURGICAL, LTD. RYAN O'LEARY
K132306 11/21/2013 PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE PERSYST DEVELOPMENT CORP. DARI DARABBEIGI
K131913 11/26/2013 INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH MARKUS STACHA
K132526 11/26/2013 KNIT-PAK+ PREMIER DENTAL PRODUCTS CO. VINCENT D'ALLESANDRO
K132726 11/29/2013 ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM PRIMERADX FAYYAZ MEMNON
K122338 11/05/2013 PREFERRED BLOOD GLUCOSE MONITORING SYSTEM PRODIGY DIABETES CARE, LLC E.J. SMITH
K122340 11/26/2013 PRODIGY CHOICE PRODIGY DIABETES CARE, LLC E J SMITH
K123514 11/01/2013 CLEARPATH ALIGNER QSERVE AMERICA, INC. PATSY TRISLER
K132294 11/12/2013 GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS RADIOLOGY SOLUTIONS LLC DANIEL KAMM
K123977 11/21/2013 RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K132066 11/21/2013 INFLAMMA DRY RAPID PATHOGEN SCREENING, INC. DOUGLAS BUESCHEL
K131693 11/01/2013 RAYSCAN A-EXPERT RAY CO., LTD ANDREW PAENG
K131695 11/01/2013 RAYSCAN A-EXPERT 3D RAY CO., LTD ANDREW PAENG
K130554 11/22/2013 REDSENSE ALARM SYSTEM REDSENSE MEDICAL AB PATRIK BYHMER
K131932 11/08/2013 APNEALINK PRO RESMED GERMANY INC. SANDRA GRUNWALD
K132371 11/22/2013 EASYCARE ONLINE RESMED LTD. JIM CASSI
K132168 11/20/2013 BRONCHOSCOPY ELBOW RESPIRONICS, INC. COLLEEN WITT
K133282 11/27/2013 REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM REVERSE MEDICAL CORPORATION JEFFREY VALKO
K131026 11/14/2013 BOSCH BLOOD PRESSURE METER (BP5000 BT) ROBERT BOSCH HEALTHCARE SYSTEMS, INC. LOUISE MUSANTE
K133330 11/26/2013 C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN ROCHE DIAGNOSTICS SUSAN HOLLANDBECK
K133284 11/22/2013 ELECSYS CK-MB CALCHECK 5 ROCHE DIAGNOSTICS KELLI TURNER
K132970 11/29/2013 LESSRAY SAFERAY SPINE, LLC CALLEY HERZOG
K133329 11/27/2013 UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEM SAMSUNG MEDISON CO., LTD PARK KYEONG-MI
K131355 11/07/2013 CONCEIVE PLUS SASMAR INC JOHN-MICHAEL MANCINI
K131997 11/26/2013 NEWTRON BOOSTER SATELEC-ACTEON GROUP RICK ROSATI
K132859 11/18/2013 INTEGRA FACET FIXATION SYSTEM SEASPINE, INC. MICHELLE WILLIS
K131655 11/04/2013 LIGHTHOUSE(TM) URINARY CATHETER SEEDINGS LIFE SCIENCE VENTURES, LLC KEN SOLOVAY
K132918 11/22/2013 SENSE-4BABY SYSTEM SENSE4BABY, INC. JACQUES GINESTET
K131646 11/26/2013 DISPOSABLE INFUSION SET SHANGHAI JINTA MEDICAL CO., LTD WANG CHANGQING
K130848 11/12/2013 SHANGHAI PHOENIX MECHANICAL WHEELCHAIR SHANGHAI PHOENIX MEDICAL EQUIPMENT CO., LTD. KE-MIN JEN
K132170 11/26/2013 SHASER V-MINI RX SHASER, INC. ANTHONY BURNS
K131921 11/15/2013 ELECTRONIC PULSE STIMULATOR SHENZHEN JINGKEHUI ELECTRONIC CO., LTD BILL DAI
K131243 11/12/2013 NON-CONTACT INFRARED THERMOMETER SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD FIELD FU
K132779 11/19/2013 DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K133067 11/22/2013 ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT SIEMENS HEALTHCARE DIAGNOSTICS, INC. KIRA GORDON
K131275 11/08/2013 MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS SIEMENS HELATHCARE DIAGNOSTICS INC. ELISABETH WARINER
K133226 11/12/2013 BIOGRAPH MMR SIEMENS MEDICAL SOLUTIONS USA, INC. NADIA SOOKDEO
K132951 11/15/2013 MAGNETOM AERA SIEMENS MEDICAL SOLUTIONS USA, INC. NADIA SOOKDEO
K132119 11/22/2013 MAGNETOM PRISMA, MAGNETOM PRISMA FIT SIEMENS MEDICAL SOLUTIONS USA, INC. NADIA SOOKDEO
K132831 11/01/2013 QUIET/SILENT SCANNING SUITE SIEMENS MEDICAL SOLUTIONS USA, INC. NADIA SOOKDEO
K130649 11/01/2013 SILK ROAD ACCESS CATHETER SILK ROAD MEDICAL, INC RICHARD M RUEDY
K132527 11/14/2013 DIGITAL COLOR DOPPLER ULTASOUND SYSTEM SONOSCAPE COMPANY LIMITED TOKI WU
K131262 11/14/2013 DIGITAL ELECTROCARDIOGRAPHS SONOSCAPE COMPANY LIMITED DIANA HONG
K132189 11/22/2013 OTOMAG BONE CONDUCATION HEARING SYSTEM SOPHONO, INC KRISTA B TRAYNOR
K130066 11/12/2013 SPECTRUM SPINE SPINOUS PROCESS DEVICE SPECTRUM SPINE IP HOLDINGS, LLC RICH JANSEN
K132029 11/25/2013 VAULT-C INTERVERTEBRAL BODY FUSION DEVICE SPINAL USA MEREDITH MAY
K132603 11/20/2013 APEX SPINE SYSTEM SPINECRAFT LLC AMI AKALLAL-ASAAD
K132740 11/26/2013 SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM SPINEFRONTIER, INC. PAUL L SPEIDEL
K122024 11/26/2013 SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR SPS MEDICAL SUPPLY CORP. GARY J SOCOLA
K132372 11/26/2013 STERITEC GREEN CARD PACK BOWIE-DICK TEST STERITEC PRODUCTS MFG. CO., INC. JONATHAN RUTIGLIANO
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