FDA 510(k) Applications Received During July, 2014

FDA 510(k) Number Submission Date Device Name Applicant Contact
K141770 07/01/2014 LUNA CPAP AND AUTO-CPAP SYSTEM 3B MEDICAL, INC ALEX LUCIO
K142034 07/28/2014 3M STERI-VAC STERILIZER/AERATOR 3M COMPANY MATT MORTENSEN
K141823 07/07/2014 AAP LOQTEC CLAVICLE PLATES 2.7/3.5 AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K141949 07/18/2014 CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K141782 07/02/2014 HI-TORQUE VERSATURN GUIDE WIRE Abbott Vascular VIVEK THAKKAR
K141919 07/15/2014 VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR AD REM TECHNOLOGY SARL NORMAN F ESTRIN
K141912 07/15/2014 AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON ADVANCED ORTHOPAEDIC SOLUTIONS, INC. ANNA HWANG
K141993 07/22/2014 NAKOMA ACP ALLIANCE PARTNERS, LLC KELLEN HILLS
K141945 07/17/2014 ECHOSTAR COMFORT 1.5T MRI ALLTECH MEDICAL SYSTEMS AMERICA, INC. MICHAELEEN DOM
K141852 07/09/2014 IFS ADVANCED FEMTOSECOND LASER SYSTEM AMO MANUFACTURING USA, LLC RODNEY HUANG
K141984 07/21/2014 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO., LTD LIU YI
K141865 07/10/2014 DANA ANTHROTRONIX, INC CORINA E LATHAN, PHD, PE
K141969 07/21/2014 FIRSTSTIC N INTRODUCER ARGON MEDICAL DEVICES, INC SUZANNE CHEANG
K142035 07/28/2014 GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM ARKRAY FACTORY INC. LONNA M DENDOOVEN
K141920 07/16/2014 Wrist Hemiarthroplasty System ARTHROSURFACE, INC. DAWN J WILSON
K141981 07/21/2014 ASAHI FUBUKI 043 / ASAHI FUBUKI ASAHI INTECC CO., LTD. CANDACE CEDERMAN
K142078 07/31/2014 VELASII THERAPY LASER SYSTEM ASPEN LASER SYSTEMS, LLC A. BRAUN HENDERSON
K142056 07/29/2014 LIOLI IOL DELIVERY SYSTEM AST PRODUCTS, INC. William Lee
K142036 07/28/2014 INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS B. BRAUN MEDICAL, INC. TRACY MADDOCK
K142011 07/24/2014 SOLUTION SET/EXTENSION SET BAXTER HEALTHCARE CORPORATION TIFFANY LIN
K141932 07/16/2014 AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS BECKMAN COULTER, INC. ANTHONY DENNIS
K141810 07/07/2014 BD BACTEC PLUS ANAEROBIC/F (PLASTIC) Becton, Dickinson and Company Paul Swift
K141973 07/21/2014 DIODE LASER HAIR REMOVAL SYSTEM BEIJING ANCHORFREE TECHNOLOGY CO., LTD Diana Hong
K142023 07/25/2014 LUNA INTERBODY SYSTEM BENVENUE MEDICAL, INC. CINDY DOMECUS, R.A.C. (US & EU)
K141924 07/16/2014 HD BLOOD PRESSURE MONITOR BIOCARE ASIA CORPORATION LTD. Ke-Min Jen
K141830 07/07/2014 STIMULAN KIT, STIMULAN RAPID CURE BIOCOMPOSITES LTD. MARIE WHALLEY
K141798 07/03/2014 SYPHER SPACER SYSTEM BIOGENNIX, LLC MEREDITH MAY, MS, RAC
K141893 07/14/2014 VIBRANCE KEGEL DEVICE (VKD) BIOINFINITY (M)SDN.BHD. Carrie Hetrick
K141975 07/21/2014 WATERLASE IPLUS S BIOLASE, INC. COLLEEN BOSWELL
K141910 07/15/2014 Intraosseous Cannula System Bio-MAC? and Bio-CORE BIOLOGIC THERAPIES INC AL LIPPINCOTT
K141791 07/02/2014 BIOMET FUSION SYSTEM BIOMET SPINE TED KUHN
K141804 07/03/2014 POLARIS SPINAL SYSTEM - HA COATED BIOMET SPINE LLC, KIMBERLY MCCOY
K141762 07/01/2014 PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM BIOMET, INC. LONNIE WITHAM
K142020 07/25/2014 LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND BIOBAG 50/100/200/300/400 BIOMONDE ROSINA ROBINSON, RN, MED, RAC
K141820 07/07/2014 JAGWIRE HIGH PERFORMANCE GUIDWIRE BOSTON SCIENTIFIC CORP. ALLISON BAILLIE
K141943 07/17/2014 BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM BREATHE TECHNOLOGIES Samir Ahmad
K141831 07/07/2014 HYDRAVIEW GUIDEWIRE BRIVANT LIMITED KENNETH WALSH
K141785 07/02/2014 MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIES BSD MEDICAL CORP. DIXIE TOOLSON SELLS
K141985 07/22/2014 TRUE BA V BALLOON VALVULOPLASTY CATHETER C.R. BARD, INC. AARON CONOVALOFF
K142083 07/31/2014 TRUE FLOW VALVULOPLASTY PERFUSION CATHETER C.R. BARD, INC. AARON CONOVALOFF
K142030 07/25/2014 STGC-LORDOTIC CARDINAL SPINE, LLC KEVIN A. THOMAS
K141965 07/21/2014 PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT CAREFUSION JOY GREIDANUS
K141936 07/17/2014 MICROBLAB, MICROLOOP CAREFUSION GERMANY 234 GMBH ELMAR NIEDERMEYER
K141837 07/07/2014 DRX-EVOLUTION CARESTREAM HEALTH,INC. CAROLYN L WAGNER
K141844 07/08/2014 RESCAN 700, CALLISTO EYE CARL ZEISS MEDITEC AG MANDY AMBRECHT
K141859 07/10/2014 CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING CENTERS FOR DISEASE CONTROL AND PREVENTION Yon Yu, Pharm.D.
K142047 07/28/2014 EIDON CENTERVUE SPA ROGER GRAY
K141942 07/17/2014 MIDLINE II TI CENTINEL SPINE, INC. JUSTIN EGGLETON
K142079 07/31/2014 STALIF CTI, STALIF C CENTINEL SPINE, INC. JUSTIN EGGLETON
K142045 07/28/2014 XPERT FLU/RSV XC ASSAY CEPHEID SCOTT A CAMPBELL,PH.D.,MBA
K141829 07/07/2014 GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM CERAGEM MEDISYS INC. Hak-Sung Kim
K141880 07/11/2014 BIOPOR AOC POROUS POLYETHYLENE, CEREPOR CEREMED, INC. CHELSEA MITCHELL
K141806 07/03/2014 CLEAR GUIDE ONE CLEAR GUIDE MEDICAL JACK KENT
K141909 07/15/2014 COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP COLLAGEN MATRIX, INC. PEGGY HANSEN
K141818 07/07/2014 TURBO-JECT PICC SETS COOK CORPORATED SEAN SPENE
K142012 07/24/2014 FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS CORPAK MEDSYSTEMS STEPHANIE WASIELEWKI
K141858 07/10/2014 CLOSURERFG RADIOFREQUENCY GENERATOR COVIDIEN Laura Moen-Ftacek
K142048 07/28/2014 EMPRINT PROCEDURE PLANNING APPLICATION Covidien LLC HEATHER V NIGRO
K141894 07/14/2014 SHARKCORE FINE NEEDLE BIOPSY SYSTEM COVIDIEN LLC (FORMERLY BEACON ENDOSCOPIC CORP) Saket Bhatt
K141801 07/03/2014 HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM COVIDIEN, LLC JULIE UNDERDAHL
K142000 07/23/2014 ESOFLIP ES CROSPON, LTD. PAUL DRYDEN
K142072 07/23/2014 GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) CUSTOM ORTHOPAEDIC SOLUTIONS, INC. JUSTIN J BAKER,PHD
K141809 07/07/2014 RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM DEFIBTECH, LLC Ed Horton
K142076 07/31/2014 CLAVEGUARD FREEDOM SURGICAL LIGHT DICKSON & DICKSON HEALTHCARE (US), INC RAGUNATH MUNIANDY
K141970 07/21/2014 DIGITEK TITANIUM ABUTMENT DIGITEK DENTAL SOLUTIONS LIMITED ALWIN NGAI
K142064 07/30/2014 GALILEO NT EB NEURO, S.P.A. ALLISON SCOTT, RAC
K141900 07/14/2014 SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE ECKERT & ZIEGLER BEBIG GMBH HUB VAN DE BERGH
K142080 07/31/2014 NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED ECOLAB, INC. JENNIFER WILLNER
K141958 07/18/2014 ERB ENDORECTAL BALLOON EDGE MEDICAL LLC GREGORY MATHISON
K141855 07/09/2014 CLARITY ELEKTA LTD.
K141990 07/22/2014 ENCORE HUMERAL SHOULDER STEM ENCORE MEDICAL, L.P. TEFFANY HUTTO
K141916 07/15/2014 PATHASSIST LED LIGHT FIBER Entellus Medical, Inc. GARRETT P AHLBORG
K141986 07/22/2014 ELUX 810 LASER EQUIPMED NORTH AMERICA, INC. JIM BARLEY
K142042 07/28/2014 ERCHONIA SHL ERCHONIA CORPORATION Kevin Walls
K142008 07/23/2014 MYLABSEVEN, MYLABALPHA ESAOTE S.P.A. Allison Scott
K142077 07/31/2014 MYLABGAMMA ESAOTE, S.P.A. Allison Scott
K141952 07/18/2014 ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED ETHICON ENDO-SURGERY, INC. LINDA HILL
K141776 07/02/2014 STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES ETHICON, INC. PETER CECCHINI
K141827 07/07/2014 EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE EUROIMMUN U.S., Inc. MICHAEL A LOCKE
K142038 07/28/2014 EUROIMMUN LYME ELISA(IgG/IgM) EUROIMMUN US MICHAEL LOCKE
K141797 07/02/2014 ALTEON 6.5MM BONE SCREWS EXACTECH, INC. THOMAS MCNAMARA
K141821 07/07/2014 ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET EXACTECH, INC. THOMAS MCNAMARA
K141960 07/18/2014 Exactech« Novation« Crown Cup« EXACTECH, INC. THOMAS MCNAMARA
K141850 07/09/2014 FLOSPINE PEDICLE SCREW SYSTEM FLOSPINE RICH JANSEN
K141997 07/23/2014 CRIT-LINE IV SYSTEM FRESENIUS MEDICAL CARE DENISE OPPERMANN
K142003 07/23/2014 FDR D-EVO II FLAT PANEL DETECTOR SYSTEM FUJIFILM MEDICAL SYSTEM U.S.A., INC. KATHERINE Y CHOI
K141765 07/01/2014 FDR D-EVO FLAT PANEL DETECTOR SYSTEM FUJIFILM MEDICAL SYSTEMS U.S.A., INC. KATHERINE Y CHOI
K142017 07/25/2014 X-PORTE ULTRASOUND SYSTEM FUJIFILM SonoSite, Inc. Patricia Liau
K141768 07/01/2014 LOGIQ V5/LOGIQ V3 GE HEALTHCARE BRYAN BEHN
K141963 07/18/2014 12SL ECG ANALYSIS PROGRAM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. KRISTIN PABST
K142085 07/31/2014 DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T GE MEDICAL SYSTEMS, LLC JENNY WONG
K141961 07/18/2014 GENADYNE SPIRO FOAM DRESSING KIT GENADYNE BIOTECHNOLOGIES, INC. CHIEN MING GOH
K142044 07/28/2014 CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE Guangzhou Wondfo Biotech Co., Ltd. Joe Shia
K141862 07/10/2014 HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE H2 Inc. Feng-Yu Lee
K142063 07/30/2014 #8C RENEGADE DENTAL HANDPIECE HANDPIECE CLUB, LLC TINA WU
K141822 07/07/2014 SENSEI X ROBOTIC CATHETER SYSTEM HANSON MEDICAL, INC. TODD MILHOLLAND
K141892 07/14/2014 QK-SYSTEMIC THERAPEUTIC APPARATUS HARBIN QUANKE MEDI-TECHNICAL DEVELOPMENT CO., LTD. WANG XIANGLIN
K141869 07/11/2014 QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT HEMEDEX INCORPORATED DEAN HONKONEN
K141921 07/16/2014 HIVOX SPOPAD EMS HIVOX BIOTEK, INC. Ke-Min Jen
K142029 07/25/2014 MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM HOLOGIC, INC. SARAH FAIRFIELD
K142037 07/28/2014 QUANTRA HOLOGIC, INC. CATHERINE WILLIAMS
K141944 07/17/2014 HOME ACCESS AIC TEST HOME ACCESS HEALTH CORP. Sandra D White
K141792 07/02/2014 GENESIS TOUCH SYSTEM HONEYWELL HOMMED CLAUDIA JACKSON
K141789 07/02/2014 PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE HOSPIRA, INC. Yuliya Matlin
K142054 07/29/2014 IMACOR ZURA EVO IMAGING SYSTEM IMACOR INC. JAMES W MONROE
K141803 07/03/2014 IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY Immunalysis Corporation joseph Ginete
K141872 07/11/2014 SUDOSCAN IMPETO MEDICAL INC Calley Herzog
K141764 07/01/2014 TRISTAR BONE GRAFT FIXATION SYSTEM IMPLADENT, LTD. MAURICE VALEN
K141950 07/18/2014 HFD100 ROCKER ARM ACCESSORY IMRIS, INC. KARISSA HOLCOMB
K142057 07/29/2014 INFIX CANNULATED SCREW SYSTEM INFIX MEDICAL LLC JAMES C HOLLEY
DEN140022 07/18/2014 GLAUCOMA COMPANION INNOVATEX, INC. STEPHEN C CHEN
K141967 07/21/2014 PUREFILL OXYGEN COMPRESSOR INOVO, INC. PAUL DRYDEN
K141841 07/08/2014 INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP INTEGRA LIFESCIENCE CORPORTATION NICOLE C HARLAN
K141922 07/16/2014 IRIS INTELLIGENT RETINAL IMAGING SYSTEM INTELLIGENT RETINAL IMAGING SYSTEMS, LLC RYAN BOUCHARD
K141783 07/02/2014 TDX SP2 POWER WHEECHAIR INVACARE CORPORATION DOUG UELMEN
K141848 07/09/2014 IOGYN SYSTEM IOGYN, INC. RICH CHRISTENSEN
K141861 07/10/2014 HILTHERA 4.0 JEISYS MEDICAL, INC. Priscilla Chung
K142043 07/28/2014 INSYNC ZR HIGH TRANSLUCENCY ZIRCONIA JENSEN INDUSTRIES, INC. JORDAN SCHRECK
K141825 07/07/2014 IDEAL Locking Plate System JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LT ALICE GONG
K141777 07/02/2014 NEODENT IMPLANT SYSTEM JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S KEVIN A THOMAS
K142016 07/25/2014 CAPRI K2M, INC. NANCY GIEZEN
K141873 07/11/2014 RANGE/MESA/DENALI SPINAL SYSTEM K2M, INC. NANCY GLEZEN
K141781 07/02/2014 KOGENT SPETZLER LIGHTED SUCTION TUBES KATALYST SURGICAL, LLC MERYL KOCH
K141891 07/14/2014 MEDICAL LCD MONITOR KOSTEC CO., LTD Priscilla Chung
K141902 07/14/2014 LAGIS ENDOSCOPIC INSTRUMENTS DISPOSABLE GRASPER LAGIS ENTERPRISES CO, LTD. CORA CHEN
K141908 07/15/2014 DUAL SWITCH LASER ENGINEERING, INC. LAURIE DOBBS
K141877 07/11/2014 LEAF PATIENT MONITORING SYSTEM LEAF HEALTHCARE, INC. RONALD S WARREN
K141905 07/15/2014 PRO-LINK WEDGE SYSTEM LIFE SPINE RANDY LEWIS
K141769 07/01/2014 OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER LIGHTLAB IMAGING, INC. JEFFREY ROBERTS
K141934 07/17/2014 PHYSICA KR KNEE SYSTEM LIMACORPORATE S.P.A. EMANUELE BUTTAZZONI
K141989 07/22/2014 MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM MAKO SURGICAL CORPORATION JONATHAN REEVES
K142069 07/30/2014 GMK EXTENSION MEDACTA INTERNATIONAL ADAM GROSS
K141988 07/22/2014 M.U.S.T PEDICLE SCREW SYSTEM MEDACTA INTERNATIONAL ADAM GROSS
K141926 07/16/2014 INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM MEDELA AG ADRIENNE LENZ
K142022 07/25/2014 MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES MEDLINE RENEWAL RICHARD D WYNKOOP
K142068 07/30/2014 BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE MEDOVATIONS, INC. LAURA BOLL
K141951 07/18/2014 DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE MEDTRONIC INC. KEVIN T LAM
K141833 07/07/2014 STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION MEDTRONIC NAVIGATION, INC. CHRISTOPHER PERMAN
K141824 07/07/2014 MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP MEDTRONIC SOFAMOR DANEK, INC. COURTNEY N LONG
K142051 07/28/2014 PRELUDE PLASTIC JACKETED GUIDE WIRE MERIT MEDICAL SYSTEMS INC. MICHAEL O'SULLIVAN
K141870 07/11/2014 BREAST VOLUME NAVIGATOR METRITRACK LLC MIRELA WOHLFORD
K142014 07/24/2014 SOFIA DISTAL ACCESS CATHETER MICROVENTION, INC. Naomi Gong
K141885 07/11/2014 CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY MINXRAY, INC. DANIEL KAMM
K142032 07/25/2014 MRI PATIENT MONITORING SYSTEM TESLA M3 MIPM MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN ANDRE KINDSVATER
K141886 07/14/2014 MDK HANDPIECES MODERN KOREA CO., LTD. Priscilla Chung
K141847 07/09/2014 AVANCE FOAM DRESSING KITS MOLNLYCKE HEALTH CARE US, LLC ANGELA L BUNN, RAC
K141983 07/21/2014 NEUROBLATE SYSTEM MONTERIS MEDICAL CORP CRAIG COOMBS
K141811 07/07/2014 MORTARA MONITORING WAVEFORM VIEWER MORTARA INSTRUMENT, INC. AMY YANG
K142033 07/25/2014 VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP) NANOSPERE,INC. NOAH LERMER
K141771 07/01/2014 PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY NANOSTRING TECHNOLOGIES INC. SYLVA KRIZAN
K141933 07/16/2014 FILAO NC RX PTCA DILATATION CATHETER NATEC MEDICAL LTD JUDITH DANIELSON
K142084 07/31/2014 EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX NCONTACT SURGICAL, INC. JANE RICUPERO
K141832 07/07/2014 3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE NEOCOIL, LLC MICHAEL LEIGH
K142025 07/25/2014 NEUROLUMEN PN-1000 NEUROLUMEN, LLC Doug Durning
K142060 07/29/2014 TRANSOM ANTERIOR CERVICAL PLATE NEUROSTRUCTURES, INC. MEREDITH MAY
K142040 07/28/2014 OCS-B COLLAGEN NIBEC CO LTD DANIEL NAM
K141907 07/15/2014 STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A NOVA BIOMEDICAL CORPORATION PAUL W MACDONALD
K141994 07/22/2014 BULK FILL FLOWABLE COMPOSITE NOVOCOL, INC. CORA BRACHO-TROCONIS
K141968 07/21/2014 NUVASIVE NVM5 SYSTEM NUVASIVE, INC. JEREMY MARKOVICH
K141896 07/14/2014 COROENT SYSTEM NUVASIVE, INCORPORATED OLGA LEWIS
K142050 07/28/2014 NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEM NUVASIVE, INCORPORATED MICHELLE CHEUNG
K141759 07/01/2014 OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS OAK RIDGE PRODUCTS, LLC CONOR J O'MALLEY
K141851 07/09/2014 NAVILAS LASER SYSTEM OD -OS GMBH JUDY F GORDON
K141914 07/15/2014 PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM OK BIOTECH CO., LTD. Ke-Min Jen
K141991 07/22/2014 SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP OLYMPUS MEDICAL SYSTEMS COPR. DAPHNEY GERMAIN-KOLAWOLE
K141978 07/21/2014 MAXPOWER RELIEF OMRON HEALTHCARE, INC. PAUL DRYDEN
K141787 07/02/2014 SAGITTILT ORFIT INDUSTRIES NV Lee Leichter
K141784 07/02/2014 ORTHO SOLUTIONS ULTOS PLATING SYSTEM ORTHO SOLUTIONS LIMITED AL LIPPINCOTT
K141857 07/10/2014 CrossTie Intraosseous Fixation System ORTHODISCOVERY GROUP LLC (D.B.A. CROSSROADS EXTREM VERNON HARTDEGEN
K142052 07/28/2014 ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT ORTHOFIX SRL CHERYL WAGONER
K141760 07/01/2014 ORTHOFIX GALAXY WRIST ORTHOFIX SRL CHERYL WAGONER
K141842 07/08/2014 STARBAND, STARLIGHT ORTHOMERICA PRODUCTS, INC. DAVID C KERR
K142081 07/31/2014 CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGES OSPREY MEDICAL, INC. MELANIE HESS
K141930 07/16/2014 OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML OSSEON LLC KEITH BURGER
K141911 07/15/2014 OPTIMUS NEURO SYSTEM OSTEONIC CO., LTD. Priscilla Chung
K141854 07/09/2014 INSTRUMENT CASSETTE (EFCCL1-F) OSUNG MND CO., LTD KIRAN SHEIKH
K141812 07/07/2014 MYGAIT STIMULATION SYSTEM OTTO BOCK HEALTHCARE PRODUCTS GMBH RENE URTZ
K141790 07/02/2014 AQANIFE OVESCO ENDOSCOPY AG TANJA R LINZER
K141794 07/02/2014 ENDO-MARYLAND DISSECTOR OVESCO ENDOSCOPY AG TANJA R LINZER
K142005 07/23/2014 SpineFab Vertebral Body Replacement (VBR) System OXFORD PERFORMANCE MATERIALS LEIGH AYRES
K141875 07/11/2014 Pasture 60S Surgical Mask PASTURE PHARMA PTE LTD SARAH HASSAN
K141876 07/11/2014 Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator PASTURE PHARMA PTE LTD SARAH HASSAN
K141979 07/21/2014 ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V. JEANETTE BECKER
K141883 07/11/2014 CLINISCANSM EEG PICOFEMTO LLC SRIKANT KRISHNA
K142027 07/25/2014 888 WNLE POWERED WHEELCHAIR PIHSIANG MACHINERY MFG. CO., LTD. DAVID LIN
K141998 07/23/2014 SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS PINGHU SAMA MEDICAL PACKING CO., LTD. CHARLES SHEN
K141913 07/15/2014 PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME! PJUR GROUP LUXEMBOURG SA CANDACE F CEDERMAN
K141816 07/07/2014 HEMOPORE Polyganics BV BETTY IJMKER
K142041 07/28/2014 POROSTEON PHUSION METAL CERVICAL CAGE POROSTEON, INC. ROBERT A POGGIE, PHD
K141839 07/08/2014 PREMIER ETCH PREMIER DENTAL PRODUCTS CO. VINCENT D'ALESSANDRO
K141923 07/16/2014 INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X PRISMATIK DENTALCRAFT, INC. Marilyn Pourazar
K141788 07/02/2014 OBSIDIAN MILLING BLOCKS PRISMATIK DENTALCRAFT, INC. ARMIN ZEHTABCHI
K141887 07/14/2014 OBSIDIAN PRESS (ALL CERAMIC AND POM) PRISMATIK DENTALCRAFT, INC. ARMIN ZEHTABCHI
K141956 07/18/2014 FIBERGRAFT BG MORSELS PROSIDYAN, INC JANICE M HOGAN
K141793 07/02/2014 PULMONE MINIBOXPFT 2.0 PULMONE ADVANCED MEDICAL DEVICES, LTD. SUSAN ALPERT
K141863 07/10/2014 PURICORE WOUND HYDROGEL SPRAY DRESSING PURICORE INC. ART MORSE
K141834 07/07/2014 SAPPHIRE ADMINISTRATION SET Q CORE MEDICAL LTD Rhona Shanker
K142002 07/23/2014 BREAST SPEEDER CX, GRID HOLDER CX QUALITY ELECTRODYNAMICS, LLC. Kathleen Aras
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