FDA 510(k) Decisions During July, 2012  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K121075 07/26/2012 NERVEVISION SOFTWARE SYSTEMS 3D IMAGING PARTNERS INC. CAROLYN PRIMUS
K121569 07/27/2012 MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM ACCEL SPINE DANIEL CHON
K121748 07/27/2012 THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL ACCESS SCIENTIFIC, INC. ALBERT MISAJON
K113162 07/20/2012 SLIDEWIRETM(TRADEMARK PENDING) ACME-MONACO CORP. BENJAMIN SWEENEY
K121161 07/13/2012 EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER ACTA MEDICAL LLC AARON COMPTON
K120903 07/13/2012 CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE ACUMED LLC BRITTANY CUNNINGHAM
K121282 07/24/2012 MICROLUX/DL MICROLUX/BLU BIO/SCREEN ADDENT, INC. JOSHUA FRIEDMAN
K121253 07/17/2012 MERIDIAN CRANIAL PERFORATOR ADEOR MEDICAL TECHNOLOGIES GMBH FABIO VON ZEPPELIN
K121879 07/27/2012 VEGA KNEE SYSTEM AESCULAP IMPLANT SYSTEMS JULIE TOM WING
K121948 07/20/2012 CR 10-X DIGITIZER AGFA HEALTHCARE N.V.
K121871 07/03/2012 AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING AIRSTRIP TECHNOLOGIES, LP ROBERT ANDREW MILLER
K121905 07/26/2012 ALERE PBP2A TEST ALERE SCARBOROUGH, INC Angela Drysdale
K113436 07/12/2012 ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT ALFA WASSERMANN HYMAN KATZ
K113382 07/19/2012 ACE ALT REAGENT ALFA WASSERMANN HYMAN KATZ
K113435 07/02/2012 ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT ALFA WASSERMANN HYMAN KATZ
K113374 07/13/2012 ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. HYMAN KATZ
K113262 07/03/2012 ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. HYMAN KATZ
K121888 07/26/2012 E-CUBE 15 ALPINION MEDICAL SYSTEMS CO., LTD DONGHWAN KIM
K121937 07/26/2012 E-CUBE INNO ALPINION MEDICAL SYSTEMS CO., LTD DONGHWAN KIM
K113849 07/31/2012 HQS INTRODUCER ALSEAL JEAN-FRANCOIS DELFORGE
K121612 07/20/2012 ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION AMERICAN MEDICAL SYSTEMS NGOC LINH PHAM LATCHMAN
K110898 07/26/2012 S.C.O.R.E.S. UNIT AMMED SURGICAL EQUIPMENT, LLC DAVID C FURR
K120836 07/12/2012 0.9% SODIUM CHLORIDE FLISH SYRINGE AMUSA KAREN THOMISON
K120896 07/26/2012 WI-FI BODY SCALE ANDON HEALTH CO., LTD LIU YI
K120827 07/13/2012 QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE) ANGIOTECH KIRSTEN STOWELL
K111260 07/26/2012 A/C ENZYMATIC VITAMIN B6 ASSAY ANTICANCER INC QINGHONG HAN
K120649 07/06/2012 AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM APEX BIO TECHNOLOGY CORP LISA LIU
K112331 07/05/2012 BIOPURE PORTABLE RO SYSTEMS ARION WATER, INC. ROBERT LIVINGSTION
K120969 07/11/2012 AC LENS BRANDED CONTACT LENS CASE ARLINGTON CONTACT LENS SERVICES,INC. Christian Smith
K121306 07/12/2012 SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE ARTHOCARE CORPORATION CHERYL FREDERICK
K113489 07/27/2012 ORION ASCLEPION LASER TECHNOLOGIES GMBH ANTJE KATZER
K120414 07/31/2012 OSSEOSPEED PLUS ASTRA TECH AB LINDA K SCHULZ
K120338 07/05/2012 ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA ASTRA TECH INC. B A BROWN
K120937 07/06/2012 SUNFLOWER WARNER ATOM MEDICAL CORPORATION PAUL DRYDEN
K121788 07/23/2012 NIO 5MP BARCO NV LIEVEN DE WANDEL
K113073 07/27/2012 IO-TOME DEVICE BAXANO, INC. EDWARD J SINCLAIR
K121190 07/26/2012 CONTOUR NEXT BLOOD GLUCOSE METER BAYER HEALTHCARE LLC CHARLES RYAN
K120138 07/05/2012 BD MAX MRSA ASSAY, BD MAX INSTRUMENT BD DIAGNOSTICS (GENEOHM SCIENCES CANADA, INC) RAYMOND J BOULE
K112622 07/19/2012 HANDHELD ECG MONITOR BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. Diana Hong
K121198 07/12/2012 BW685, BW685S BIEGLER GMBH PAUL DRYDEN
K121512 07/26/2012 SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM BIO-LOGIC SYSTEMS CORP. DON WILLIAMS
K113610 07/09/2012 ANA-SCREEN WITH MDSS Bio-Rad Laboratories Juang Wang
K121794 07/11/2012 LIQUICHEK URINE CHEMISTRY CONTROL BIO-RAD, DIAGNOSTICS GRP. SUZANNE PARSONS
K113311 07/17/2012 TIO2MESH TM BIOCER ENTWICKLUNGS GMBH CHERYL FISHER
K121122 07/03/2012 DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL BIOCHEMICAL DIAGNOSTIC, INC. ALLEN PANETZ
K121578 07/31/2012 ATOM 1 (MODEL: BRC 2200) BIOELECTRIC RESEARCH CORPORATION STEVEN KAYE
K121270 07/19/2012 BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM BIOJECT MEDICAL TECHNOLOGIES INC. CHRISTINE BREITBACH
K112818 07/31/2012 VIDAS D-DIMER EXCLUSION II (DEX2) BIOMERIEUX, INC. VERONICA DAENZER
K121183 07/26/2012 COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS BIOMET CORPORATION PATRICIA SANDBORN BERES
K113306 07/16/2012 CARDIO 7 BIONET CO., LTD. MARC GOODMAN
K121113 07/12/2012 BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER BIOPSY SCIENCES, LLC SHARON ROCKWELL
K121441 07/20/2012 CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP) BOVIE MEDICAL CORPORATION RICHARD A KOZLOFF
K121745 07/13/2012 MANTARAY GUIDEWIRES BRIDGEPOINT MEDICAL JILL MUNSINGER
K120668 07/30/2012 SENTINEL C-RAD POSITIONING AB JANINA OSTLING
K120926 07/27/2012 ENDOBEAM HOLMIUM LASER FIBERS C.R. BARD, INC. TERRI MORRIS
K121856 07/11/2012 ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION C.R. BARD, INC. ERIN FOX
K113229 07/20/2012 VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING C.R. BARD, INC. STEPHANIE BAKER
K121303 07/26/2012 MOBILE C-ARM CANON, INC.-MEDICAL EQUIPMENT GROUP DIANE RUTHERFORD
K121897 07/27/2012 PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES CARDINAL HEALTH, INC. TATYANA BOGDAN
K120176 07/25/2012 SENZZZZZ AWAY CENTRIX, INC. LINDA K SCHULZ
K121474 07/16/2012 DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD. CHARLES MACK
K121669 07/03/2012 WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS) CINCINNATI SUB-ZERO PRODUCTS, INC. STEVEN J BERKE
K121683 07/05/2012 ACCULIF TL CAGE COALIGN INNOVATIONS, INC. JUSTIN EGGLETON
K113498 07/20/2012 DISPOSABLE TORQUE DEVICE COEUR, INC. DEBRA F MANNING
K121833 07/16/2012 OSTOMY IRRIGATION SET COLOPLAST A/S TIM CRABTREE
K121759 07/24/2012 CONE-TROL LIQUID CHEMISTRY CONTROLS CONE BIOPRODUCTS WILL CONE
K120941 07/03/2012 CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM CONSTANT CARE, LLC SETH A MAILHOT
K121275 07/25/2012 AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER CONVATEC INC KATRINA FIEDLER
K120468 07/06/2012 NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR COOK INCORPORATED SUSANNE GALIN
K120834 07/19/2012 CORPATH 200 SYSTEM CORINDUS INC. MONA ADVANI
K120773 07/10/2012 NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM Covidien LLC CHARLIE MACK
K121510 07/25/2012 IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H SARAH RIZK
K120402 07/13/2012 CRUX VENA CAVA FILTER SYSTEM CRUX BIOMEDICAL ELISA HEBB
K120285 07/02/2012 K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER CURATIVE MEDICAL INC. AMY MCKINNEY
K121449 07/10/2012 DIRECTPATH CYBERNET SYSTEMS CO., LTD. DIANE SUDDUTH
K111454 07/05/2012 ILUMINAGE DIODE LASER CYNOSURE, INC. GEORGE CHO
K120530 07/05/2012 DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION S DENTIN IMPLANTS TECHNOLOGIES LTD. DANIELA LEVY
K121617 07/27/2012 SENSICARDIAC DIACOUSTIC MEDICAL (PTY) YOLANDA SMITH
K121053 07/31/2012 DIAZYME HOMOCYSTEINE POC TEST KIT DIAZYME LABORATORIES Abhijit Datta
K113562 07/16/2012 3MP COLOR LCD MONITOR, RADIFORCE RX340 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K120253 07/16/2012 ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS) ELCAM MEDICAL A.C.A.L. AHARON COHEN
K121448 07/02/2012 ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY ELEKTA INC. D/B/A NUCLETRON CORPORATION THOMAS VALENTINE
K122095 07/26/2012 ICP TRIAGEMANAGER Emergo Europe Consulting BV RACHIDA ZIANI
K121835 07/20/2012 DOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATELLA WITH VE ENCORE MEDICAL, L.P. MICHAELA NORRIS
K121650 07/09/2012 S-SCAN ESAOTE, S.P.A. Allison Scott
K121600 07/16/2012 ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE ETHICON ENDO-SURGERY, LLC ASIFA VONHOF
K121349 07/18/2012 IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER EXTREMITY MEDICAL LLC JAMY GANNOE
K121417 07/18/2012 XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM EXTREMITY MEDICAL LLC JAMY GANNOE
K121950 07/26/2012 MICROTARGETING XL STAR DRIVE SYSTEM FHC, INC. KERI SEITZ
K121125 07/06/2012 FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM FLEXIBLE STENTING SOLUTIONS, INC. JOSEPH C GRIFFIN III
K111939 07/11/2012 M/29TM - PRESSURE INJECTABLE FLEXICATH LTD. TALI HAZAN
K120726 07/06/2012 FLIGHT 60 VENTILATOR FLIGHT MEDICAL INNOVATIONS LTD. CHOSHANA FRIEDMAN
K120413 07/13/2012 SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK FOCUS DIAGNOSTICS, INC. TARA VIVIANI
K112193 07/12/2012 ARROW REVERSE SHOULDER SYSTEM FOURNITURES HOSPITALIERES INDUSTRIE PATRICIA DONNARD
K120636 07/05/2012 SYNAPSE 3D CARDIAC TOOLS FUJIFILM MEDICAL SYSTEM U.S.A., INC. JYH-SHYAN LIN
K112391 07/26/2012 FUJINON COLONOSCOPES FUJINON, INC. GINA WALLJASPER
K120598 07/19/2012 PROCARE MONITOR B40 GE MEDICAL SYSTEMS CHINA CO., LTD. ROBERT CASARSA
K120569 07/20/2012 GEMORE TENS SYSTEM GEMORE TECHNOLOGY CO., LTD. BODEN S.P. LAI
K110558 07/12/2012 CS1000 LIGHT THERAPY DEVICE GENESIS HEALTH LIGHT CORPORATION PAUL ZIEMER
K120263 07/10/2012 VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM GENORAY CO., LTD. JAE KIM
K121922 07/26/2012 BEACON STABILIZATION SYSTEM GLOBUS MEDICAL INC. MERIAM YOUSSEF
K121107 07/03/2012 FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R) GLOBUS MEDICAL, INC. SARAH M FITZGERALD
K121908 07/25/2012 SAFETY INFUSION SET GREINER BIO-ONE NORTH AMERICA, INC. JUDITH SMITH
K121557 07/25/2012 WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST Guangzhou Wondfo Biotech Co., Ltd. Joe Shia
K120474 07/10/2012 GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY GYRUS ACMI, INC. GRAHAM BAILLE
K111401 07/19/2012 BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBE HANGZHOU BEVER MEDICAL DEVICES CO., LTD. ALLYSON ZHOU
K111406 07/19/2012 BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL) HANGZHOU BEVER MEDICAL DEVICES CO., LTD. ALLYSON ZHOU
K120958 07/25/2012 POSISEP AND POSISEP X HEMOSTAT DRESSINGS HEMOSTASIS, LLC BERNARD HORWATH
K120914 07/25/2012 FLEXITIME FAST & SCAN LIGHT FLOW HERAEUS KULZER, LLC JAMIE MEARNA
K113574 07/13/2012 FLEXITIME MONOPHASE PRO SCAN HERAEUS KULZER, LLC CHRIS HOLDEN
K113307 07/27/2012 GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM HMD BIOMEDICAL, INC. JESSICA TUNG
K120564 07/16/2012 CALYPSO SYSTEM HOGAN LOVELLS US LLP JANICE M HOGAN
K121868 07/19/2012 MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK) HOLOGIC, INC. SARAH FAIRFIELD
K120582 07/06/2012 HEATLUX HOME SKINOVATIONS LTD. AMIR WALDMAN, PH.D
K121308 07/30/2012 HIP SYSTEMS HOWMEDICA OSTEONICS CORP KAREN ARIEMMA
K120920 07/16/2012 HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA HSINER COMPANY TOM SHANKS
K110425 07/27/2012 HC-BIOS DENTAL IMPLANT HUNG CHUN BIO-S CO., LTD. MICHAEL LEE
K121133 07/10/2012 CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM i-SENS, Inc. HYUN JOON OH
K121517 07/20/2012 VERSAVUE ENTERPRISE SUITE ICAD, INC. MICHAEL A PATZ
K120753 07/26/2012 CLARISCT ICRCO INC. GREG WACHTLER
K121231 07/30/2012 IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST IND NDIAGNOSTIC INC. KAI LOU
K113192 07/13/2012 HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM INFOPIA CO., LTD Priscilla Chung
K120374 07/09/2012 SEVIIN REVERSE SHOULDER INGEN ORTHOPEDICS LLC PERRY GEREMAKIS
K112634 07/03/2012 NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP INOTEC AMD LTD. Diane Horwitz
K112545 07/31/2012 QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM INOVA DIAGNOSTICS, INC. MICHAEL MAHLER
K121159 07/20/2012 INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER INTEGRA LIFESCIENCE CORPORTATION STEVEN PELTIER
K113620 07/12/2012 MYRIAN 1.11 INTRASENSE FREDERIC BANEGAS
K121319 07/18/2012 ZIO PATCH IRHYTHM TECHNOLOGIES, INC. MICHAEL RIGHTER
K121572 07/19/2012 CONTINUOUS SINGLE CULTURE COMPLETE IRVINE SCIENTIFIC SALES CO., INC. JAYME YAMAGUCHI-OWENS
K121338 07/27/2012 ZEOBI IVIVI HEALTH SCIENCE, LLC KATHRYN CLUBB
K121359 07/27/2012 IPS 99 ONE AND IPS 99 CERAM IVOCLAR VIVADENT AG DONNA MARIE HARTNETT
K120377 07/25/2012 ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A J. MORITA USA, INC. KEITH A BARRITT
K121808 07/20/2012 CASIAN, 3.5/4.5 CONNECTORS K2M, INC. NANCY GIEZEN
K121301 07/30/2012 XPRESSWAY RX CATHETER (6F LD-VERISON) KANEKA PHARMA AMERICA LLC JOSEPH DEPAOLO
K113056 07/03/2012 ORANGE COLORED CONDOMS ORANGE SCENT KAREX INDUSTRIES SDN BHD LAI PENG LIM
K111465 07/25/2012 COMPOTHIXO KERRHAWE SA Wendy Garman
K113199 07/30/2012 KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT KEVO MEDICAL SUPPLIES E.J. Smith
K120650 07/11/2012 POISE PERSONAL LUBRICANT KIMBERLY-CLARK CORPORATION Swarna Mukund
K121583 07/25/2012 CLEARFIL MAJESTY FLOW KURARAY NORITAKE DENTAL INC. KIYOYUKI ARIKAWA
K121096 07/06/2012 VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM L & K BIOMED CO., LTD KI HYANG KIM
K113285 07/26/2012 LDR SPINE USA AVENUE L INTERBODY FUSION LDR SPINE USA INC. MARITZA ELIAS
K120511 07/30/2012 AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM LETO ENTERPRISE LTD. SABRINA WEI
K120640 07/18/2012 INSUFLOW SYNERGY PORT LEXION MEDICAL, LLC. BERNARD HORWATH
K121838 07/11/2012 LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM LIEBEL-FLARSHEIM CRAIG BUEHLER
K121471 07/10/2012 LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS LIGHTSCALPEL LLC GERALD S PALECKI
K111014 07/13/2012 LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES LSI SOLUTIONS, INC. JUDE S SAUER, M.D.
K120514 07/05/2012 CARDIOPACS LUMEDX CHRIS PEARCE
K121912 07/24/2012 E1 EAR SENSORS MASIMO CORPORATION DAVID COLLETTE
K120733 07/05/2012 SIMPLANT GO MATERIALISE DENTAL NV GEERT APPELTANS
K112389 07/20/2012 SURGICASE CONNECT, SURGICASE GUIDE MATERIALISE N.V. Alexandra Razzhivina
K113621 07/06/2012 SMARTDRIVE WHEELCHAIR POWER-ASSIST MAX MOBILITY, LLC WILLIAM M RICHTER
K120812 07/12/2012 RENAISSANCE MAZOR ROBOTICS LTD AHAVA STEIN
K121416 07/20/2012 GMK SPHERE MEDACTA INTERNATIONAL ADAM GROSS
K121115 07/18/2012 M.U.S.T PEDICLE SCREW SYSTEM MEDACTA INTERNATIONAL ADAM GROSS
K121376 07/24/2012 COMPRESSION CARE FLIGHT MEDICAL MINDS LLC DAVID PLATT
K121323 07/18/2012 MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE MEDICREA INTERNATIONAL LAURE AVIRON-VIOLET
K120849 07/20/2012 HYBRID ARCTICGEL PAD MEDIVANCE, INC. LYNNE ARONSON
K120966 07/03/2012 DEPUY PULSE LUMBAR CAGE SYSTEM MEDOS INTERNATIONAL SARL ROBIN DINARDO
K120424 07/11/2012 MEDSOURCE IV ADMINSTRATION SET MEDSOURCE INTERNATIONAL, LLC. JENNIFER NESS
K121767 07/13/2012 CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE MEDTRONIC INC. MARY E DONLIN
K120988 07/25/2012 DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT MEDTRONIC INC. JACQUELINE HAUGE
K121982 07/26/2012 SOVEREIGN SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK LAUREN KAMER
K121680 07/05/2012 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. CHRIS MCKEE
K121832 07/17/2012 RESOLVE BILIARY LOCKING DRAINAGE CATHETER MERIT MEDICAL SYSTEMS, INC. CASEY HUGHES
K113513 07/13/2012 PLANCET MICROPOINT TECHNOLOGIES PTE LTD CHEE Y LIM
K112390 07/13/2012 MONICA AN24 MONICA HEALTHCARE LTD. IAN HOW
K120865 07/19/2012 RSCRIBE ELECTROCARDIOGRAPH MORTARA INSTRUMENT, INC CHARLES MORREALE
K120195 07/06/2012 SAFETY SUBCUTANEOUS TISSUE INFUSION SET MULTI MED TANYA O'BRIEN
K121954 07/17/2012 NMI MICROCATHETER NAVILYST MEDICAL, INC. WANDA CARPINELLA
K112674 07/06/2012 NAVIS TORQUER NAVIS MEDICAL,INC MATTHEW J HUDDLESTON
K120244 07/05/2012 SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR NEXERA MEDICAL INC PAUL SALLARULO
K121195 07/25/2012 NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER NINEPOINT MEDICAL, INC CINDY DOMECUS
K121529 07/12/2012 BLACK NITRILE POWDER-FREE EXAMINATION GLOVES NORTHSTAR HEALTHCARE HOLDINGS WESLEY TOAVS
K121464 07/05/2012 BLUE POWER FREE NITRILE EXAMINATION GLOVE NORTHSTAR HEALTHCARE HOLDINGS MICHAEL RIORDAN
K121506 07/03/2012 UTB BLUE POWDER FREE NITRILE NORTHSTAR HEALTHCARE HOLDINGS WESLEY TOAVS
K120302 07/06/2012 MECHANICAL WHEELCHAIR NOVAF ANDALUCIA 2007, SL FERNANDO SAENZ DE SANTAMARIA
K120283 07/31/2012 DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT NOVOCOL, INC. CORA BRACHO-TROSONIS
K121837 07/16/2012 NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM NUVASIVE, INC. Cynthia Adams
K121407 07/09/2012 OXYBAND WOUND DRESSING O2S, LLC DAVID E PETKO, P.E.
K121604 07/27/2012 ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT OBP CORPORATION JASON SWIFT
K121293 07/26/2012 CS-SERIES-FP WITH 3030+OPTION OMEGA MEDICAL IMAGING, LLC BRIAN J FLEMING
K112368 07/19/2012 CAPNOSTREAM20P WITH AI/ODI ORIDION MEDICAL 1987 LTD. RACHEL WEISSBROD
K113869 07/26/2012 ORIGEN REINFORCED DUAL LUMEN CATHETER Origen Biomedical, Inc. RICHARD MARTIN
K121658 07/20/2012 ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM) ORTHOFIX INC. ALLY BADUEL
K120566 07/24/2012 O2PAK OXYGEN GENERATOR PACIFIC PRECISION PRODUCTS GERALD WHITE
K113819 07/11/2012 MONGOOSE ANGIOGRAPHIC CATHETER PEDIACATH INC. CAROLINE TONTINI
K120884 07/03/2012 PERICAM PSI PERIMED AB MARIA LILJEVRET
K121638 07/18/2012 ST80I STRESS TEST SYSTEM PHILIPS HEALTHCARE GRETAL LUMLEY
K120366 07/18/2012 INTELLIVUE PATIENT MONITOR PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN MARKUS STACHA
K121733 07/13/2012 INFILL INTERVERTEBRAL BODY FUSION DEVICE PINNACLE SPINE GROUP, LLC Rebecca K Pine
K120016 07/26/2012 PIONEER STERNAL ASSIST IMPLANT SYSTEM PIONEER SURGICAL TECHNOLOGY, INC SARAH MCINTYRE
K112101 07/17/2012 FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS POLYMED THERAPEUTICS, INC TERRI WALLACE
K113544 07/27/2012 ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER PROSPERA CORPORATION Kevin Walls
K113070 07/10/2012 PROTEUS INGESTION CONFINMATION SYSTEMS PROTEUS BIOMEDICAL, INC. JAFAR SHENASA
DEN120011 07/10/2012 PROTEUS INGESTION CONFINMATION SYSTEMS PROTEUS BIOMEDICAL, INC. JAFAR SHENASA
K113118 07/31/2012 STENTUBE LACRIMAL INTUBATION SET QUEST MEDICAL, INC. AMY CLENDENING-WHEELER
K121428 07/17/2012 NON-CONTACT CLINICAL THERMOMETER RADIANT INNOVATION INC. JAMES HUANG
K121746 07/11/2012 RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID) RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K121609 07/02/2012 ASTHMAPOLIS SYSTEM RECIPROCAL LABS CORPORATION INGER L COUTURE
K113656 07/26/2012 CAREGUIDE OXIMETER REFLECTANCE MEDICAL INC Nandini Murthy
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