FDA 510(k) Applications Received During September, 2013

FDA 510(k) Number Submission Date Device Name Applicant Contact
K132967 09/20/2013 3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP 3B MEDICAL, INC ALEX LUCIO
K133106 09/30/2013 COMPUTED RADIOGRAPHY SCANNER 3DISC AMERICAS DANIEL KAMM
K133120 09/30/2013 COMPUTED RADIOGRAPHY SCANNER 3DISC AMERICAS DANIEL KAMM
K132787 09/06/2013 LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K133115 09/30/2013 COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK ABBOTT MEDICAL OPTICS INC Rosanne Yetemian
K133002 09/24/2013 i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials ABBOTT POINT OF CARE INC. MELISSA ROBINSON
K133096 09/30/2013 ABB VIE J ABBVIE INC. KATHERINE WORTLEY
K133129 09/30/2013 ABBVIE NJ ABBVIE INC. KATHERINE WORTLEY
K133087 09/30/2013 ABBVIE PEG ABBVIE INC. KATHERINE WORTLEY
K132833 09/10/2013 ULTRA RENEW PLUS ACCORD MEDIA MICHAEL CHIBBARO
K132832 09/10/2013 ACTIVAPATCH ET IONTOPHORESIS PATCH ACTIVATEK INC. JAMAL YANAKI
K132769 09/04/2013 ACUMED HAND PLATING SYSTEM ACUMED LLC MARIAH KNIGHT
K132976 09/23/2013 ADVATX ADVALIGHT APS MAUREEN O'CONNELL
K133081 09/30/2013 TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N ADVANCED ORTHOPAEDIC SOLUTIONS, INC. KAZUNORI MIYAHARA
K132821 09/09/2013 AGAMATRIX HEALTH MANAGER AGAMATRIX INC WILLIAM H MCGRAIL
K132800 09/06/2013 SKINTELL AGFA HEALTHCARE N.V. SHAEANN CAVANAGH
K133079 09/30/2013 IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC) ALDEN OPTICAL LABS., INC. KEVIN RANDALL
K132933 09/18/2013 THE MOSES ELITE APPLIANCE ALLEN J. MOSES, DDS, LTD. ALLEN J MOSES, DDS
K132975 09/23/2013 SPHINX JR ALLMED SYSTEMS INC. PETER ALLEN
K133036 09/26/2013 APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS AMENDIA INC. RICH JANSEN
K132925 09/18/2013 SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAVANNAH-LINK AMENDIA, INC. JOHN KAPITAN
K132965 09/20/2013 SOLACE SOUND GENERATORS AMPLISOUND HEARING PRODUCTS & SERVICES RALPH T CAMPAGNA
K133117 09/30/2013 ANDON BLOOD PRESSURE CUFF ANDON HEALTH CO., LTD LIU YI
K132923 09/18/2013 FUSION SINGLE LINK ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA TARA CONRAD
K133043 09/26/2013 PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE ANGIOSLIDE, LTD CLAY ANSELMO
K133119 09/30/2013 FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS ARJOHUNTLEIGH POLSKA SP Z.O.O. DAVID MOYNHAM
K132905 09/16/2013 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER ARTERIOCYTE MEDICAL SYSTEMS, INC. ANN CHAREST
K132896 09/16/2013 CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE ASIA-MED GMBH AND CO KG Kevin Walls
K133091 09/30/2013 ZIP MIS INTERSPINOUS FUSION SYSTEM AURORA SPINE JUSTIN EGGLETON
K133070 09/30/2013 SURGICAL FACE MASK (Ear Loops and Tie-on) B.H. MEDICAL PRODUCTS CO., LTD. LEON LU
K132734 09/03/2013 NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS BAXTER HEALTHCARE CORP. GARY CHUMBIMUNE
K133008 09/25/2013 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
K132909 09/17/2013 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML) Becton, Dickinson and Company KATIE COYLE
K132989 09/24/2013 SPEED 808 DIODE LASER SYSTEM BEIJING TOPLASER TECHNOLOGY CO., LTD. ZHANG XIAOSONG
K132817 09/09/2013 KIVA VCF TREATMENT SYSTEM BENVENUE MEDICAL, INC. CINDY DOMECUS, R.A.C. (US & EU)
K133049 09/27/2013 3I T3(R) EXTERNAL HEX DENTAL IMPLANTS BIOMET 3I CHRIS MCKEE
K132898 09/16/2013 A.L.P.S. CALCANEAL PLATING SYSTEM BIOMET MANUFACTURING CORP. JARED COOPER
K132873 09/13/2013 VANGUARD XP KNEE SYSTEM BIOMET, INC. JULIE GANTENBERG, M.S.
K132825 09/09/2013 RETROMTA-ORTHOMTA II BIOMTA Priscilla Chung
K133003 09/25/2013 RIGHTEST CONTROL SOLUTION BIONIME CORPORATION JIGAR SHAH
K132958 09/20/2013 MEDICINAL LEECHES BIOPHARM (UK) LTD. BETHANY SAWYER
K133047 09/27/2013 RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU BIOPHOR DIAGNOSTICS, INC. Nathaniel G Butlin
K132782 09/06/2013 CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2 BIOSENSE WEBSTER, INC. WAYNE R HOHMAN
K132960 09/20/2013 BIOMONITOR BIOTRONIK, INC. Jon Brumbaugh
K133009 09/25/2013 NASAL MASK, NASAL MASK, FULL FACE MASK BMC MEDICAL CO., LTD MS. JINJING
K132892 09/16/2013 TEBCO-W BOMED INC B. BO SRAMEK, PH.D
K132914 09/17/2013 ACUITY PRO LEAD DELIVERY SYSTEM BOSTON SCIENTIFIC HOLLY RAMIREZ
K132947 09/19/2013 DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS BOSTON SCIENTIFIC CORP. MAUREEN SUNDEEN
K132810 09/09/2013 GLADIATOR ELITE PTA BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. BETH TOROK
K132990 09/24/2013 OCCLUSION BALLOON CATHETER BOSTON SCIENTIFIC CORP. DIANE NELSON
K133110 09/30/2013 EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM Boston Scientific Corporation RENEE MITCHELL
K132763 09/04/2013 ADVANCED VIEWER BRAINLAB, AG ALEXANDER SCHWIERSCH
K132942 09/19/2013 SITE-RITE VISION II ULTRASOUND SYSTEM C.R. BARD, INC. KERRIE HAMBLIN
K132987 09/24/2013 COBRA FUNDUS CAMERA C.S.O. S.R.L. Claude Berthoin
K133073 09/30/2013 CAIR DRIVE, NEUTRACLEAR CAIR LGL IRVING WIESEN
K132764 09/04/2013 MOTION WATCH AND PRO-DIARY CAMNTECH, LTD HOWARD SMITH
K132774 09/05/2013 PICCOLO COMPOSITE NAILING SYSTEM CARBOFIX ORTHOPEDICS LTD. YAEL RUBIN
K132824 09/09/2013 CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION CARESTREAM HEALTH,INC. DAVID C FURR
K132867 09/13/2013 SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM CAYENNE MEDICAL, INC. SHIMA HASHEMIAN
K132963 09/20/2013 FUSIONSYNC, CHIMAERA FUSIONSYNC CHIMAERA GMBH MARCUS PRUEMMER
K132799 09/06/2013 CLARISO PACS CLARISO, INC. CARL ALLETTO
K133069 09/30/2013 CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES CODENT TECHNICAL INDUSTRY CO., LTD. CHIN-TING WEN
K132738 09/03/2013 COGENT MED-LIF COGENT SPINE LLC JUDE PAGANELLI
K133029 09/26/2013 ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE COMPRESSION WORKS, LLC MICHAEL FORSTADT
K133116 09/30/2013 VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC CONMED CORPORATION NANCY GERTLAR
K133011 09/25/2013 DIAPHRAGMATIC HERNIA GRAFT COOK BIOTECH, INC. MARY A FADERAN PH.D., RAC
K133114 09/30/2013 MICROPUNCTURE INTRODUCER SET COOK INCORPORATED DAVID LEHR, RAC
K132885 09/16/2013 TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET COOK INCORPORATED SEAN SPENCE
K133130 09/30/2013 BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER COOK, INC. DAVID E CHADWICK, PHD., RAC
K132994 09/24/2013 ANODYNE ANTERIOR CERVICAL PLATE SYSTEM CORELINK LLC J.D. WEBB
K132993 09/24/2013 COUNTER OTC TENS DEVICE COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD. GUENTER GINSBERG
K132795 09/06/2013 CYBERWAND STERILE PROBE SET CYBERSONICS, INC. LORI COLVIN
K132815 09/09/2013 PUREGRAFT 50 SYSTEM CYTORI THERAPEUTICS, INC. KENNETH K KLEINHENZ
K133098 09/30/2013 SENYINT PACS DALIAN SENYINT DIGITAL MEDICAL SYSTEM CO., LTD. LEON LU
K132875 09/13/2013 COMPRESSYN STAPLE DALLEN MEDICAL, INC. AL MEMMOLO
K132792 09/06/2013 ECOSHIP DISPOSABLE SHARPS CONTAINER, ECOSHIP DISPOSABLE SHARPS CONTAINER DANIELS SHARPSMART, INC. ALLISON KOMIYAMA
K133074 09/30/2013 MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES DATASCOPE CORP. LINDA SLUTZKY
K133090 09/30/2013 OXICARE FINGERTIP PULSE OXIMETER DELBIO INCORPORATION ERICA LI
K132959 09/20/2013 DEPUY PINNACLE ALTRX ACETABULAR LINERS DEPUY ORTHOPAEDICS, INC. MEGAN BURNS
K133007 09/25/2013 DX3000-L DEXCOWIN CO., LTD Claude Berthoin
K132830 09/10/2013 DISTALOCK TIBIAL IM NAIL SYSTEM DGIMED ORTHO, INC SCOTT YOUNGSTROM
K133014 09/25/2013 DMS 300-2W HOLTER ECG RECORDER DIAGNOSTIC MONITORING SOFTWARE WILLIAM PARSONS
K133083 09/30/2013 DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET DIAZYME LABORATORIES Abhijit Datta
K133105 09/30/2013 BREEZE NEBULIZER (NBR-10X) DIGIO2 INTERNATIONAL CO., LTD MICHAEL LEE
K132759 09/04/2013 VENTRAIN DOLPHYS MEDICAL B.V. FABIENNE PETERS
K132903 09/16/2013 DRE VENTURA DRE MEDICAL, INC. PAUL DRYDEN
K132842 09/10/2013 FLAATZ 600 SERIES (FLAATZ 600/601) DRTECH CORP. CHOUL-WOO SHIN
K133097 09/30/2013 E-Z LINK DUOJECT MEDICAL SYSTEMS, INC. MARIE-CHRISTINE MESSIER
K132794 09/06/2013 SMARTVEST AIRWAY CLEARANCE SYSTEM ELECTROMED, INC. CHET SIEVERT
K132949 09/19/2013 PELLEFIRM ELLMAN INTERNATIONAL, INC. Alison Sathe
K133019 09/26/2013 FIBERION OPHTHALMIC ENDOLASER PROBE EMTRON ELEKTRONIK VE MEKANIK SANAYI VE TICARET LIM MEHMET MELEK
K132839 09/10/2013 FUSE 1C COLONOSCOPY SYSTEM ENDOCHOICE, INC. DANIEL HOEFER
K132776 09/05/2013 SEAL BIOPSY VALVE - REUSABLE ENDOCHOICE, INC. DANIEL HOEFER
K132754 09/03/2013 NEOGEN PSR SYSTEM ENERGIST, LTD. DARREN THOMAS
K132930 09/18/2013 MYHEALTHPOINT TELEHEALTH MANAGER ENTRA HEALTH SYSTEMS RICHARD STROBRIDGE
K133064 09/27/2013 MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31 ENVITEC-WISMAR GMBH STEPHEN GORSKI
K133104 09/30/2013 VAN HIP FRACTURE SYSTEM EPIX ORTHOPAEDIC, CORP. MICHELLE MCDONOUGH
K132899 09/16/2013 EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD) EQUASHIELD MEDICAL LTD RAYMOND J KELLY, IV
K132940 09/19/2013 ERCHONIA ALLAY ERCHONIA MEDICAL, INC. Kevin Walls
K133017 09/26/2013 ESTECH COBRA(R) GENESIS BIPOLAR CLAMP ESTECH, INC. TAMER IBRAHIM
K132868 09/13/2013 CARRICELL ETEX CORPORATION MICHAEL STRUNK, PHD.
K132777 09/05/2013 NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER EV3 INC
K133100 09/30/2013 CAREFINE PEN NEEDLE FACET TECHNOLOGIES MARY ANN KINARD
K133102 09/30/2013 FLOWER ANKLE PLATING SET FLOWER ORTHOPEDICS CORPORATION JANICE M HOGAN
K133080 09/30/2013 Plus Surgical Drapes (EO Sterilized), PMDB-XXX FOSHAN NANHAI PLUS MEDICAL CO., LTD. LEON LU
K133075 09/30/2013 Plus Surgical Gowns (EO Sterilized), PMGB-XXX FOSHAN NANHAI PLUS MEDICAL CO., LTD. LEON LU
K132806 09/06/2013 FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE FOTONA D.D. STOJAN TROST
K133006 09/25/2013 NEOV DIODE LASER FAMILY G.N.S NEOLASER LTD. GIL SHAPIRA
K133034 09/26/2013 LOGIQ F SERIES GE HEALTHCARE BRYAN BEHN
K132913 09/17/2013 VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10 GE HEALTHCARE BRYAN BEHN
K132944 09/19/2013 ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION GE HUNGARY KFT STEPHEN SLAVENS
K132822 09/09/2013 BD MAX STAPHSR ASSAY, INSTRUMENT GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) PATRICIA DIONNE
K133077 09/30/2013 GENERICA MEDICAL ENTERNAL DELIVERY; PUMP BAG SET, PUMP SPIKE SET, GRAVITY BAG SET GENERICA MEDICAL INTERNATIONAL, INC. JIM BARLEY
K132957 09/20/2013 MADSEN ACCUSCREEN TYPE 1077 GN OTOMETRICS DANIEL KAMM, P.E.
K133037 09/26/2013 GRINDGUARD GRIND GUARD TECHNOLOGIES, LLC WILLIAM G MCLAIN
K132744 09/03/2013 ACESSA GUIDANCE SYSTEM HALT MEDICAL INC. CLARISA TATE
K132937 09/18/2013 HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA) HARVEST DENTAL PRODUCTS, LLC ANDREW ROWE
K132855 09/12/2013 HEARTWAY POWER MOBILITY SCOOTER HEARTWAY MEDICAL PRODUCTS CO., LTD. JEN KE-MIN
K132856 09/12/2013 HEARTWAY POWER WHEELCHAIR HEARTWAY MEDICAL PRODUCTS CO., LTD. JEN KE-MIN
K132883 09/13/2013 HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) HEMODIA S.A.S. REMI TEULIERE
K133033 09/26/2013 HIDREX PSP1000 HIDREX GMBH STEFANIE D BANKSTON
K133108 09/30/2013 FIT BELT HONG QIANG XING (SHENZHEN) ELECTRONICS LIMITED XU JIAN HUA
K132869 09/13/2013 SILDENT HRS CO., LTD. JAE-HYEON CHOI
K132796 09/06/2013 SUNTOUCH EYE SPEAR HUIZHOU FORYOU MEDICAL DEVICES CO, LTD Diana Hong
K132945 09/19/2013 CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAIL I.T.S. GMBH AL LIPPINCOTT
K132893 09/16/2013 EDGE ORTHOPAEDICS BITE COMPRESSION SCREW ICON ORTHOPAEDIC CONCEPTS DBA EDGE ORTHOPAEDICS JAN TRIANI
K132750 09/03/2013 ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY ILLUMINA, INC. BRYAN SCHNEIDER
DEN130011 09/23/2013 ILLUMINA MISEQDX PLATFORM ILLUMINA, INC. LEANNE M KIVIHARJU
K132735 09/03/2013 AXIA RADIAL HEAD SYSTEM IMDS (INNOVATIVE MEDICAL DEVICE SYSTEMS) - LEIS ME ANDREW RYNEARSON
K132971 09/23/2013 MONACO IMPAC MEDICAL SYSTEMS, INC. KATHRYN STINSON
K132912 09/17/2013 DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT IN2BONES SAS NORMAN F ESTRIN, PH.D.
K132911 09/17/2013 I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW IN2BONES SAS ERIC FOURCAULT
K133031 09/26/2013 SHARPSOLOGY 2 INDUSTRIAL WATER SOLUTIONS, INC. THOMAS P STEWART
K133045 09/27/2013 ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM INFOPIA CO., LTD SeonMi Shin
K132966 09/20/2013 GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM INFOPIA CO., LTD Priscilla Chung
K132862 09/12/2013 HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM INFOPIA CO., LTD Priscilla Chung
K132991 09/24/2013 C-BOX PEEK CERVICAL IBF INNOVASIS, INC. MARSHALL MCCARTY
K132765 09/04/2013 PFX SPINOUS PROCESS FIXATION SYSTEM INNOVASIS, INC. MARSHALL MCCARTY
K133062 09/27/2013 DISCOVERY SYSTEM INNOVATIVE VISUAL SYSTEMS DONALD R SANDERS, M.D. PH.D
K133005 09/25/2013 HEMOSIL VON WILLEBRAND ACTIVITY ASSAY INSTRUMENTATION LABORATORY CO. Jacqueline Emery
K132900 09/16/2013 MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM INTELLIGENT IMPLANT SYSTEMS, LLC MICHAEL NUTT
K132728 09/03/2013 V8 TRANSLUMINAL BAV CATHETER INTERVALVE, INC Sew-Wah Tay
K133013 09/25/2013 INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE INVENTIS SRL MASSIMO MARTINELLI
K133030 09/26/2013 DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE) INVIVO CORPORATION Lisa Simpson
K132919 09/17/2013 GANTRY BEAM LINE ION BEAM APPLICATIONS S.A. BRUCE D ARMON
K132847 09/11/2013 I2C ION BEAM APPLICATIONS S.A. BRUCE D ARMON
K132996 09/24/2013 CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS ISORAY, INC FREDRIC SWINDLER
K132984 09/24/2013 SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K132876 09/13/2013 ARIX HAND LOCKING SYSTEM JEIL MEDICAL CORPORATION HYEROUNG LEE
K132757 09/04/2013 EVEREST SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K133103 09/30/2013 AVERSION PEDICLE SCREW SYSTEM K7 LLC KAREN E WARDEN
K133126 09/30/2013 K7 LUMBAR SPACERS K7 LLC KAREN E WARDEN, PHD
K132741 09/03/2013 V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM KCI USA, INC. MELANIE AVILA
K133111 09/30/2013 KINGTECH DIGITAL THERMOMETER KINGTECH ENTERPRISE, LTD. Ke-Min Jen
K133113 09/30/2013 KINGTECH FOREHEAD THERMOMETER KINGTECH ENTERPRISE, LTD. KE MIN JEN
K133078 09/27/2013 K-ETCHANT SYRINGE; NEEDLE TIP (E) KURARAY NORITAKE DENTAL INC. MICHIO TAKIGAWA
K133063 09/27/2013 SANTIS PEDICLE SCREW SYSTEM LANTERNA MEDICAL TECHNOLOGIES RICH JANSEN, Pharm.D.
K133133 09/30/2013 LAURIMED POLYPVAC MICRODEBRIDER LAURIMED LLC NANCY LINCE, RAC
K133026 09/26/2013 UNBALLOON NON-OCCLUSION MODELING CATHETER LEMAITRE VASCULAR, INC. ANDREW HODGKINSON
K133022 09/26/2013 ZEDVIEW LEXI CO., LTD. EDWARD A KROLL
K132760 09/04/2013 NAUTILUS SPINAL SYSTEM LIFE SPINE, INC RANDY LEWIS
K132866 09/13/2013 NAUTILUS SPINAL SYSTEM LIFE SPINE, INC RANDY LEWIS
K132837 09/10/2013 LINA POWERBLADE PLUS LINA MEDICAL APS CHRISTINE E NICHOLS
K132988 09/24/2013 VITAL COUGH LUNG ASSIST, INC. LEWIS WARD
K133088 09/30/2013 ZX-27 M&M DENTAL STUDIO INC IRVING WIESEN
K133039 09/26/2013 RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM MAKO SURGICAL CORPORATION JONATHAN REEVES
K132829 09/09/2013 QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS MAQUET CARDIOPULMONARY AG WHITNEY TORNING
K132743 09/03/2013 HARVESTING CANNULA MAQUET CARDIOVASCULAR, LLC MARK DINGER
K133042 09/27/2013 ENDOCEM ZR MARUCHI Priscilla Chung
K133054 09/27/2013 ENDOSEAL MARUCHI Priscilla Chung
K133046 09/27/2013 OMNIPORE CUSTOMIZED SURGICAL IMPLANTS MATRIX SURGICAL HOLDINGS, LLC/MATRIX SURGICAL USA JULIE STEPHENS
K132848 09/11/2013 PIEZOSURGERY FLEX MECTRON S.P.A. ROGER GRAY
K132878 09/13/2013 M.U.S.T. EXTENSION MEDACTA INTERNATIONAL ADAM GROSS
K132879 09/13/2013 MPACT EXTENSION MEDACTA INTERNATIONAL ADAM GROSS
K132788 09/06/2013 MYSPINE PEDICLE SCREW PLACEMENT GUIDES MEDACTA INTERNATIONAL ADAM GROSS
K132803 09/06/2013 MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK MEDAPPS INC., DBA ALERE CONNECT KENT DICKS
K132880 09/13/2013 MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE MEDICAL COMPONENTS INC TIMOTHY HOLWICK
K132921 09/17/2013 GALAXY PLUS MEDIEN INTERNATIONAL CO., LTD DANIEL KAMM
K132890 09/16/2013 SUPRAPUBIC CATHETER AND INTRODUCER SET MEDIPLUS LTD. PAUL DRYDEN
K132767 09/04/2013 MEDLINE SHARPS CONTAINER MEDLINE INDUSTRIES, INC. TIMUR SELIMKHANOV
K133023 09/26/2013 JETSTREAM SYSTEM MEDRAD, INC. ARMA RACIC
K132928 09/18/2013 MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE MEDRAD, INC. / BAYER MEDICAL CARE, INC. LISA A EWING
K132783 09/06/2013 EXOSHAPE DUO SOFT TISSUE FASTENER MEDSHAPE, INC STEPHEN LAFFOON
K132908 09/17/2013 TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT MEDTEC, INC. AMANDA STAHLE
K132974 09/23/2013 AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR MEDTRONIC ADVANCED ENERGY, LLC GABRIELA ANCHONDO
K132730 09/03/2013 BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE MEDTRONIC INC. JESSICA SIXBERRY
K132995 09/24/2013 DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO MEDTRONIC INC. CHELSEA PIOSKE
K132897 09/16/2013 CLYDESDALE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. BRAD SHEALS
K132972 09/23/2013 AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE MEDTRONIC, INC. JULIA A NELSON
K132924 09/18/2013 MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) MEDTRONIC, INC. ERIC KALMES
K132732 09/03/2013 MEDYSSEY ANTERIOR CERVICAL FUSION CAGE MEDYSSEY USA, INC. JOHN KUCZYNSKI
K133004 09/25/2013 VENTED MILLEX -GV, CATHIVEX -GV MERCK MILLIPORE LTD. CINDY PENNY
K132952 09/19/2013 MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES) MICROVENTION, INC. LARAINE PANGELINA
K133040 09/25/2013 LED CURING LIGHT MONITEX INDUSTRIAL CO., LTD. SHU-LUNG WANG
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K132746 09/03/2013 NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION NOBEL BIOCARE USA, LLC PHUONG NGUYEN
K132749 09/03/2013 NOBELPROCERA OVERDENTURE BAR NOBEL BIOCARE USA, LLC PHUONG NGUYEN SON
K133035 09/27/2013 NORMED PELLEGRIN CALCANEUS STOP SCREW NORMED MEDIZIN-TECHNIK GMBH DALENE BINKLEY
K132853 09/12/2013 NOVAPACS NOVARAD CORP. AMY HOFFMAN
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K132816 09/09/2013 ONCENTRA BRACHY NUCLETRON B.V. LU ANNE JOHNSON
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K132778 09/05/2013 GRAB 'N GO PLUS, GRAB 'N GO DIGITAL PRAXAIR HEALTHCARE SERVICES TINA WU, PH.D.
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K133051 09/27/2013 PULMONE MINIBOX PFT TM PULMONE ADVANCED MEDICAL DEVICES, LTD Rhona Shanker
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K132761 09/04/2013 WIRELESS THERMOMETER RAIING MEDICAL COMPANY WU WEI
K132755 09/03/2013 NEUROMATE FRAMELESS GEN II RENISHAW MAYFIELD SARL STEPHANE VINOT
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K132736 09/03/2013 ACCURO 3000 ULTRASOUND SCANNER RIVANNA MEDICAL, LLC WILLIAM MAULDIN
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K132828 09/09/2013 ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3 Roche Diagnostics KELLI TURNER
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K133067 09/27/2013 ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT SIEMENS HEALTHCARE DIAGNOSTICS, INC. KIRA GORDON
K132739 09/03/2013 IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL SIEMENS HEALTHCARE DIAGNOSTICS, INC. Garo Mimaryan
K132935 09/18/2013 ARTISTE SOLUTION WITH SYS_VC10C AND SYNGO RT THERAPIST WORKSPACE, V4.3.1 UPGRADE KIT, ARIA CONNECTIVITY OPTION FOR SIEME SIEMENS MEDICAL SOLUTIONS USA, INC. CHRISTINE DUNBAR
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K132907 09/17/2013 PLIF LITE AND TLIF LITE SINTEA PLUSTEK RICH JANSEN
K133016 09/25/2013 VENT-OS SINUS DILATION SYSTEM SINUSYS CORPORATION MICHAELE A DANIEL
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K132886 09/16/2013 SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM SMITH & NEPHEW, INC. DAVID HENLEY
K132768 09/04/2013 S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM SONOSCAPE COMPANY LIMITED TOKI WU
K132969 09/23/2013 SPEC MODEL M15 SOURCE PRODUCTION & EQUIPMENT CO., INC. KELLEY RICHARDT
K132740 09/03/2013 SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM SPINEFRONTIER, INC. PAUL L SPEIDEL
K133066 09/27/2013 SPINESELECT POLYSCREW PEDICLE SCREW SYSTEM SPINESELECT, LLC RICH JANSEN, Pharm.D.
K132920 09/17/2013 SPIROX INEX DEVICE SPIROX, INC. MIKE ROSENTHAL
K132814 09/09/2013 SFI-BAR IMPLANT ABUTMENTS STERNGOLD DENTAL LLC MARIA RAO
K132844 09/11/2013 STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGES STRAUMANN USA, LLC CHRISTOPHER KLACZYK
K132747 09/03/2013 VISUM BLADE LED SURGICAL LIGHTING SYSTEM STRYKER COMMUNICATIONS TREY THORSEN
K132785 09/06/2013 STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITY Stryker Endoscopy LIFEI LIU
K132968 09/23/2013 UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM) STRYKER SPINE KRISTEN MEANY, MS, CQA, RAC
K133015 09/25/2013 INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM SUMMIT MEDICAL, INC. NICOLE DOVE
K132943 09/19/2013 INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE SYNAPTIC MEDICAL LIMITED Diana Hong
K133028 09/26/2013 RITHM ID ELECTROPHYSIOLOGY CATHETER SYNAPTIC MEDICAL LIMITED Diana Hong
K132727 09/03/2013 GEM FLOW COUPLER DEVICE AND SYSTEM SYNOVIS LIFE TECHNOLOGIES, INC. TROY THOME
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K133127 09/30/2013 LIPIFLOW THERMAL PULSATION SYSTEM TEARSCIENCE, INC. CHRISTY STEVENS, OD, MPH
K132751 09/03/2013 MULTICHEM S PLUS / S PLUS (ASSAYED) TECHNO-PATH MANUFACTURING LTD. STEPHANIE G GARTH
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K132953 09/20/2013 TIDISHEILD TIDI PRODUCTS, LLC DION BRANDT
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K132797 09/06/2013 L'DISQ U & I CORPORATION GYEONG-JE KWON
K132926 09/18/2013 VELOFIXTM INTERBODY FUSION SYSTEM U&I CORP. GYEONG JE-KWON
K132812 09/09/2013 UCP MULTI-DRUG TEST KEY CUPS UCP BIOSCIENCES, INC. NANCY CHEN
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K132983 09/23/2013 TON-95LH, PAX-I3D ORTHO VATECH CO., LTD. DAVE KIM
K132820 09/09/2013 VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES VILEX, INC. ABRAHAM LAVI
K132731 09/03/2013 DIGIFIX EXTERNAL FIXATION SYSTEM VIRAK ORTHOPEDIC RESEARCH, LLC KIMBERLY STROHKIRCH
K132742 09/03/2013 M-VU BREAST DENSITY VUCOMP, INC. RICHARD MORRONEY
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K133053 09/27/2013 MILESTONE SPINAL SYSTEM WEIGAO ORTHOPAEDIC DEVICE CO., LTD Diana Hong
K132807 09/09/2013 MONITORING STATION, CONNEX(R) CENTRAL STATION (CS) WELCH ALLYN, INC. KEVIN CROSSEN
K132808 09/11/2013 VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR WELCH ALLYN, INC. KEVIN CROSSEN
K133059 09/27/2013 INSULIN PEN NEEDLE WENZHOU BEIPU SCIENCE & TECHNOLOGY CO., LTD. Diana Hong
K133058 09/27/2013 INSULIN PEN NEEDLE WENZHOU WUZHOU IMPORT & EXPORT CO., LTD Diana Hong
K133057 09/27/2013 VIBRALUNG ACOUSTICAL PERCUSSOR Westmed, Inc. PAUL DRYDEN
K132809 09/09/2013 INSTINCT ENDOSCOPIC HEMOCLIP WILSON-COOK MEDICAL INC. SCOTTIE FARIOLE
K133125 09/30/2013 WITHINGS BLOOD PRESURE MONITOR WITHINGS JEN KE-MIN
K132895 09/16/2013 WMT IMPLANTABLE K-WIRE WRIGHT MEDICAL TECHNOLOGY, INC. LESLIE FITCH
K133094 09/30/2013 CERTEX OCT SPINAL IMPLANT SYSTEM X-SPINE SYSTEMS, INC DAVID KIRSCHMAN, M.D.
K133123 09/30/2013 NON STERILE, POWEDER FREE BLUE NITRILE EXAMINATION GLOVES - 8623F YTY INDUSTRY (MANJUNG) SDN. BHD. ANDREW LOWERY
K132863 09/12/2013 SMARTSITE VIALSHIELD YUKON MEDICAL, LLC
K132854 09/12/2013 EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR YUNG SHENG OPTICAL CO., LTD. WEN-HAN CHEN
K132881 09/13/2013 Z5C Z-Systems AG LINDA K SCHULZ
K132904 09/16/2013 ZIEHM VISION RFD ZIEHM IMAGING GMBH RICHARD L WESTRICH
K133021 09/26/2013 MIXING SYRINGE SYSTEM ZIMMER KNEE CREATIONS, INC. SHAUN HANSON
K132790 09/06/2013 INFIX ANTERIOR LUMBAR SYSTEM ZIMMER SPINE, INC DONNA SEMLAK
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K133086 09/30/2013 TITLE 2 POLYAXIAL SPINAL SYSTEM ZIMMER SPINE, INC. MICHELLE LENZ
K132841 09/10/2013 ZYNO MEDICAL ADMINISTRATION SET ZYNO MEDICAL LLC MEI ZHANG, PHD


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