FDA 510(k) Decisions During July, 2013  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K132008 07/30/2013 6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP MEDTRONIC INC. MICHELE MACHACEK
K131964 07/24/2013 BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE MEDTRONIC INC. LISA STONE
K130536 07/16/2013 EXPORT ADVANCE ASPIRATION CATHETER MEDTRONIC INC. COLLEEN MULLINS
DEN130010 07/29/2013 VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION) ABBOTT MOLECULAR, INC. NANCY W BENGTSON
K123951 07/29/2013 VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION) ABBOTT MOLECULAR, INC. NANCY W BENGTSON
K131428 07/16/2013 RADVISION ACOUSTIC MEDSYSTEMS, INC. JENNIFER WILLIAMS
K130986 07/23/2013 FRAG-LOC SYSTEM ACUMED LLC KARA BUDOR
K123418 07/21/2013 GRAM-NEGATIVE QUICKFISH BC ADVANDX, INC. BENJAMIN S CRYSTAL
K130702 07/23/2013 AIRSONETT AIR-4 AIRSONETT, AB CONSTANCE G BUNDY
K131786 07/03/2013 AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER AIRSTRIP TECHNOLOGIES, LP ROBERT ANDREW MILLER
K130657 07/15/2013 LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE ALL MEDICUS CO., LTD PRISCILLA CHUNG
K131814 07/26/2013 AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER AMECO MEDICAL INDUSTRIES RAY KELLY
K131203 07/19/2013 IHEALTH CLOUD ANDON HEALTH CO., LTD YI LIU
K130676 07/08/2013 AMBIO REMOTE HEALTH MONITORING SYSTEM ARRAYENT HEALTH LLC D/B/A AMBIO HEALTH KEVIN JONES
K131182 07/29/2013 MULTIFIX S KNOTLESS FIXATION DEVICE ARTHOCARE CORPORATION MITCHELL DHORITY
K131474 07/03/2013 ARTHREX DISTAL RADIUS PLATE SYSTEM ARTHREX, INC. COURTNEY SMITH
K132043 07/31/2013 ARTHREX SPEEDCINCH ARTHREX, INC. LEON BROWN II, PH.D.
K122652 07/02/2013 ARTHROCARE TURBINATOR WAND ARTHROCARE CORPORATION CHERYL FREDERICK
K130859 07/25/2013 HAMMERTOE CORRECTION SYSTEM ARTHROSURFACE, INC. DAWN J WILSON
K130987 07/17/2013 VALUTRODE NEUROSTIMLATION ELECTRODES AXELGAARD MFG. CO., LTD. DAN P JEFFERY
K131040 07/15/2013 EXTAVIPRO STERICAN 30G B. BRAUN MELSUNGEN AG KARIN LUBBERS
K121445 07/26/2013 TETRACHROME REAGENTS AND TETRACXP SYSTEM BECKMAN COULTER, INC. NANCY NADLER
K130253 07/15/2013 TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION BECKMAN COULTER, INC. NANCY NADLER
K131358 07/16/2013 BD PEN NEEDLE BECTON DICKINSON & CO. PASQUALE AMATO
K131331 07/10/2013 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML) BECTON, DICKINSON & CO. MONICA E GIGUERE
K131327 07/18/2013 BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM BIO COMPRESSION SYSTEMS, INC. MAUREEN GARNER
K131306 07/22/2013 IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE BIO COMPRESSION SYSTEMS, INC. MAUREEN GARNER
K130158 07/25/2013 M-SCAN BIO-RESEARCH ASSOCIATES, INC. JOHN RADKE
K131729 07/31/2013 JBAIDS PLAGUE DETECTION KIT BIOFIRE DIAGNOSTICS, INC. CYNTHIA PHILLIPS
K131936 07/31/2013 JBAIDS TULAREMIA DETECTION KIT BIOFIRE DIAGNOSTICS, INC. CYNTHIA PHILIPS
K130324 07/09/2013 STATSEAL DISC BIOLIFE, LLC CLAUDIA MASSELINK
K130949 07/30/2013 CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS BIOMET 3I LAURA HOSHUE
K131670 07/03/2013 LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT) BIOMET, INC. SUZANA OTANO
K131475 07/25/2013 BARRICADE EMBOLIZATION COIL SYSTEM BLOCKADE MEDICAL REBECCA K PINE
K131905 07/18/2013 SOLID GEL PAD BLUEMTECH PRISCILLA CHUNG
K130391 07/10/2013 EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT BOSTON SCIENTIFIC CORP. VICKY L HAGENS
K130621 07/30/2013 BROADMASTER HEALTHCARE SYSTEM BROADMASTER BIOTECH CORPORATION ROGER LAI
K131496 07/10/2013 BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE) BSN MEDICAL, INC. CARROLL D HOYLE
K131002 07/02/2013 VIDA PTV DILATATON CATHETER C.R. BARD, INC. AARON CONOVALOFF
DEN110004 07/12/2013 CABOCHON SYSTEM CABOCHON AESTHETICS, INC. BEN BRIAN
K101231 07/12/2013 CABOCHON SYSTEM CABOCHON AESTHETICS, INC. BEN BRIAN
K131106 07/03/2013 DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG WIRELESS, DIGITAL RADIOGRAPHY CXDI-801C WIRELESS, CANON INC. DIANE RUTHERFORD
K130404 07/05/2013 TIBURON SURGICAL DRAPE CARDINAL HEALTH 200, LLC LAVENIA FORD
K131332 07/19/2013 CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER CARDIOSOLUTIONS INC MICHELE LUCE
K131227 07/12/2013 PADSCAN HD SERIES BLADDER SCANNER CARENOSO TECHNOLOGY CO., LTD. ZHANG WENSHENG
K130648 07/23/2013 FORUM GLAUCOMA WORKPLACE CARL ZEISS MEDITEC AG MANDY AMBRECHT
K122458 07/30/2013 VERIZON WIRELESS REMOTE HEALTH MANAGEMENT SYSTEM CELLO PARTNERSHIP D/B/A VERIZON WIRELESS LOLITA FORBES
DEN130032 07/25/2013 XPERT MTB/RIF ASSAY CEPHEID KERRY J FLOM
K131706 07/25/2013 XPERT MTB/RIF ASSAY CEPHEID KERRY J FLOM
K131511 07/05/2013 DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR CHANGZHOU SINOLINKS MEDICAL INNOVATION CO., LTD DIANA HONG
K131159 07/25/2013 SMARTRELIEF CHATTEM, INC. ERIC JOSEPH
K131931 07/26/2013 CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST CHEMTRON BIOTECH, INC. JANE ZHANG
K131072 07/09/2013 ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC COLOPLAST A/S BRIAN SCHMIDT
K131467 07/18/2013 ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA SHAH
K130360 07/15/2013 CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION CONSTANT CARE, LLC SETH A MAILHOT
K130420 07/12/2013 SOLEA CONVERGENT DENTAL, INC CARRIE HETRICK
K124030 07/01/2013 COOK HOLMIUM LASER FIBER COOK INCORPORATED CONNIE RICE
K122091 07/29/2013 COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK, INC. SEAN SPENCE
K130766 07/17/2013 ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE COOK, INC. DAVID LEHR
K131520 07/11/2013 NEXUS ANTERIOR CERVICAL PLATE SYSTEM CORE-NEXUS LISA PETERSON
K131361 07/29/2013 WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET COVIDIEN STACEY A STRAND
K130623 07/26/2013 BARRX CHANNEL RFA ENDOSCOPIC CATHETER COVIDIEN LLC RICHELLE HOVER
K131705 07/01/2013 ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO HEALTHCARE KATHERINE ROBERTSON
K130906 07/17/2013 ENDOFLIP CATHETER CROSPON, LTD. PAUL DRYDEN
K131150 07/30/2013 CURA COMPENSATOR CURA MEDICAL TECHNOLOGIES, LLC THOMAS H FARIS
K130315 07/12/2013 IPULSE HAIR REMOVAL SYSTEM CYDEN LIMITED DAVID BRODERICK
K130431 07/25/2013 COMPRESSYN BAND DALLEN MEDICAL, INC. AL MEMMOLO
K130083 07/17/2013 DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE DEMETECH CORP. ANTHONY J DIMERCURIO
K130186 07/15/2013 DENTEK EASY BRUSH WITH FLUORIDE DENTEK ORAL CARE, INC. LINDA GILES
K130680 07/26/2013 ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS DENTSOLL, INC. DAVID C FURR
K122424 07/05/2013 ISUS IMPLANT SUPRASTRUCTURES DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K130862 07/23/2013 CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM DENTSPLY INTL., INC. HELEN LEWIS
K131191 07/22/2013 4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS DEPUY MITEK, A JOHNSON & JOHNSON COMPANY SUSAN KAGAN
K131974 07/25/2013 HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM) DEPUY MITEK, A JOHNSON & JOHNSON COMPANY KRISTINE CHRISTO
K131743 07/01/2013 CIRONA DVT FOOT GARMENT DEVON MEDICAL INC. RUTH WU
K123364 07/15/2013 25OH VITAMIN D TOTAL ELISA TEST DIASOURCE IMMUNOASSAYS, S.A. NAPOLEON MONCE
K131572 07/22/2013 MICRO AMBULATORY ECG RECORDER DIMETEK DIGITAL MEDICAL TECHNOLOGIES LTD JIMMY GUAN
K131248 07/11/2013 ETCH GEL DMG AMERICA, LLC PAMELA PAPINEUA, RAC
K131498 07/25/2013 IQQA-LIVER MULTIMODALITY SOFTWARE EDDA TECHNOLOGY, INC. DANIEL KAMM, P.E.
K123714 07/24/2013 EDWARDS EMBOL-X INTRODUCER SHEATH EDWARDS LIFESCIENCES, LLC. LUKE MEIDELL
K131090 07/03/2013 2MP COLOR LCD MONITOR, RADIFORCE MX215 EIZO CORPORATION HIROAKI HASHIMOTO
K122202 07/01/2013 ELLEX 2RT ELLEX MEDICAL PTY. LTD. KEVIN HOWARD
K123366 07/12/2013 SURGITRON 4.0 DUAL RF S5-IEC ELLMAN INTERNATIONAL, INC. ALISON SATHE
K131480 07/03/2013 EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM EMERGE MEDICAL VICTORIA TRAFKA
K124055 07/19/2013 T1040 AKA AURAWAVE ENDURANCE THERAPEUTICS BRAD BREZDEN
K123234 07/05/2013 ERMIS STERILIZATION CONTAINER SYSTEM ERMIS MEDIZINTECHNIK ANDRE WEINGERL
K130068 07/19/2013 DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) ESSEX INDUSTRIES, INC. D/B/A ESSEX CRYOGENICS OF MISSOURI KEN SEISE
K123660 07/17/2013 25-OH VITAMIN D ELISA EUROIMMUN US KATHRYN KOHL
K131185 07/15/2013 ANA SCREEN ELISA (IGG) EUROIMMUN US MICHAEL LOCKE
K131595 07/26/2013 EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM EUROTROL B.V. PAUL KOOIJMANS
K131130 07/19/2013 NAVIGATION PIN EVERGREEN ORTHOPEDIC RESEARCH LAB JEFF STEPHANIAN
K131575 07/03/2013 EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT EXACTECH, INC. PATRICK HUGHES
K130339 07/11/2013 CLINICAL ALERT NOTIFICATION EXTENSION , INC TIM GEE
K130001 07/25/2013 CARE SU01A SUCTION ASPIRATOR FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. GANG WU
K123831 07/29/2013 OPHTACATH KIT FRANCE CHIRURGAE INSTRUMENTATION BARBARA S FANT
K124035 07/03/2013 2008K@HOME HEMODIALYSIS MACHINE FRESENIUS MEDICAL CARE NORTH AMERICA DENISE OPPERMANN
K123631 07/23/2013 MFP-051 GC AMERICA, INC. MARK HEISS
K131514 07/12/2013 GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM GE VINGMED ULTRASOUND AS BRYAN BEHN
K131264 07/26/2013 KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS GEBR. BRASSELER GMBH & CO. KG ERELA DANA
K130088 07/18/2013 PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM GENORAY CO., LTD. JAE KIM
K113126 07/17/2013 ACRYLIC HERBST APPLIANCE GERGENS ORTHODONTIC LAB KAREN E WARDEN, PHD
K130785 07/26/2013 SEER 1000 GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG BERT SCHADOW
K131338 07/10/2013 DERMA HOOD GLOBALMEDIA GROUP, LLC NICHOLAS CAMPBELL
K130478 07/26/2013 SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS GLOBE MEDICAL, INC. SARAH MARIE FITZGERALD
K131449 07/30/2013 COALITION SPACER GLOBUS MEDICAL, INC. CHRISTINA KICHULA
K131763 07/15/2013 TRUSCOPE SERIES PATIENT MONITOR GUANGDONG BIOLIGHT MEDITECH CO., LTD. DIANA HONG
K131754 07/31/2013 WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40) GUANGZHOU WONDFO BIOTECH CO., LTD. JOE SHIA
K130473 07/05/2013 NITRILE POWDER FREE EXAMINATION GLOVE (ABLU) HARTALEGA SDN BHD NURUL AISYAH KONG BT ABDULLAH
K123881 07/11/2013 HEARTSINE SAMARITAN PAD 350P HEARTSINE TECHNOLOGIES, INC. JAMES MCGUINNESS
K131233 07/16/2013 HERMES MEDICAL IMAGING SUITE V5.3 HERMES MEDICAL SOLUTIONS, AB JOAKIM ARWIDSON
K123641 07/03/2013 CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH HERTART HENRIK DORGE
K131424 07/12/2013 MIPLATFORM MEDICAL IMAGING SUITE HINACOM SOFTWARE AND TECHNOLOGY, LTD. YI ISABELLE SUN
K123471 07/05/2013 ETII SA FIXTURE SYSTEM HIOSSEN INC. PATRICK LIM
K131463 07/08/2013 WRIST AUTOMATIC BLOOD PRESSURE MONITOR HONSUN (NANTONG) CO., LTD SELINA QIAN
K123171 07/03/2013 ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT HORIBA ABX S.A.S. CAROLINE FERRER
K130059 07/29/2013 ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP IBI ISRAEL BIOMEDICAL INNOVATIONS LTD. ELISSA BURG
K131549 07/26/2013 CHEMOLOCK, CHEMOLOCK PORT ICU MEDICAL INC KATHERINE KENNER
K130224 07/18/2013 ICT IMRIS, INC. DANIEL BIANK
K131805 07/18/2013 INPULSE LASER INCISIVE INC. KATHY MAYNOR
K130181 07/31/2013 GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM INFOPIA CO., LTD PRISCILLA CHUNG
K131620 07/25/2013 JONES-FX FRACTURE SYSTEM INSTRATEK, INC. JEFF SEAVEY
K123753 07/17/2013 IMDX VANR FOR ABBOTT M2000 INTELLIGENT MEDICAL DEVICES, INC FRAN WHITE
K120977 07/03/2013 DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC INTERNATIONAL TECHNIDYNE CORP. LAWRENCE PICCIANO
K122532 07/30/2013 DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES INTUITIVE SURGICAL, INC. MELISSA S GONZALEZ
K131382 07/15/2013 EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL INVIVO CORPORATION RUSTY KELLY
K131282 07/11/2013 NEXUS HEMORRHOID LIGATOR INX MEDICAL PAUL DRYDEN
K123787 07/17/2013 GREENCROSS SURGICAL MASK JINGZHOU HAIXIN GREEN CROSS MEDICAL PRODUCTS CO.,LTD XIANGYANG SONG
K131137 07/18/2013 21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5) JVC KENWOOD CORPORATION TSUKASA TASHIRO
K121310 07/11/2013 MESOTHELIUM DENTAL MEMBRANE KENSEY NASH CORPORATION LORI BURNS, MS, RAC
K131448 07/26/2013 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION KOELIS LAETITIA GERVAIS
K131117 07/26/2013 ZIRMON SERIES KUWOTECH CO., LTD PRISCILLA CHUNG
K131547 07/12/2013 LANX FUSION SYSTEM LANX, INC. ALAN BURKHOLDER
K123177 07/03/2013 STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM LASERSTIM, INC. DAVID C FURR
DEN110019 07/15/2013 NEBA SYSTEM LEXICOR MEDICAL TECHNOLOGY, LLC E. HOWARD MERRY
K112711 07/15/2013 NEBA SYSTEM LEXICOR MEDICAL TECHNOLOGY, LLC E. HOWARD MERRY
K131077 07/17/2013 LIFE SPINE PLATEAU SPACER SYSTEM LIFE SPINE RANDY LEWIS
K130305 07/24/2013 LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE LINA MEDICAL APS RICHARD GILLIS
K131035 07/02/2013 Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM LINVATEC CORPORATION D/B/A CONMED LINVATEC JOY LOVETT
K123332 07/18/2013 NAOMI-CT LK CONSULTING GROUP PRISCILLA CHUNG
K131666 07/05/2013 ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING MAQUET CARDIOPULMONARY AG SARAH BETZ
K130300 07/01/2013 HEATER-COOLER UNIT HCU 40 MAQUET CARDIOPULMONARY AG HELDER A SOUSA
K130855 07/29/2013 PTFE SUPER SHEATH INTRODUCER MARTECH MEDICAL PRODUCTS ALEXIS ERAZO
K123908 07/31/2013 OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES MATRIX SURGICAL USA JULIE STEPHENS
K123721 07/26/2013 GMK REVISION EXTENSION MEDACTA INTERNATIONAL ADAM GROSS
K131671 07/05/2013 MECTALIF MEDACTA INTERNATIONAL ADAM GROSS
K124000 07/30/2013 MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM MEDAPPS INC., DBA ALERE CONNECT KENT DICKS
K130923 07/31/2013 5F DIGNITY CT TITANIUM PORT MEDICAL COMPONENTS INC SARAH SHAFFER
K123807 07/23/2013 SHARPSCAN MEDICAL ENGINEERING DEVELOPMENT SOLUTIONS, INC. TIM CORESSEL
K132040 07/31/2013 VIAL CONNECTOR 13MM CLOSED COLLAR MEDIMOP MEDICAL PROJECTS, LTD. ILANIT GOLDGRABER
K130381 07/29/2013 ANGIOJET ULTRA POWER PULSE KIT MEDRAD, INC. AMRA RACIC
K123027 07/25/2013 CAPSTONE(R) SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. LEE GRANT
K131269 07/10/2013 DLP CORONARY OSTIAL PERFUSION CANNULAE MEDTRONIC, INC. KEVIN T LAM
K130805 07/03/2013 MENICON UNIQUE PH MULTI-PURPOSE SOLUTION MENICON CO. LTD. ELLEN M BEUCLER
K131853 07/17/2013 MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER MENTOR WORLDWIDE LLC MANCHI CHEUNG
K131401 07/02/2013 BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER MERCATOR MEDSYSTEMS, INC. PLAMENA ENTCHEVA-DIMITROV, PHD
K131710 07/29/2013 MERIT HYDROPHILIC GUIDE WIRE MERIT MEDICAL SYSTEMS, INC. MARTHA FOLAN
K132041 07/31/2013 REXTAR X META BIOMED, INC. BLIX WINSTON
K123343 07/11/2013 THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS MICROGENICS CORP. KAREN LEE
K131278 07/11/2013 MONTERIS MEDICAL NEUROBLATE SYSTEM MONTERIS MEDICAL, INC. CRAIG COOMBS
K131955 07/30/2013 NEUROBLATE(TM) SYSTEM MONTERIS MEDICAL, INC. CRAIG COOMBS
K130706 07/25/2013 DUOFLEX COIL SUITE (1.5T) MR INSTRUMENTS, INC. ROBERT BECK
K131942 07/31/2013 NMI PICC III CATHETER, NMI HPICC III CATHETER NAVILYST MEDICAL, INC. LORRAINE M HANLEY
K131688 07/18/2013 NEOCLOSE HASSON, NEOCLOSE UNIVERSAL NEOSURGICAL LTD ORLA BRENNAN
K130919 07/02/2013 SENSUS NEUROMETRIX, INC. RAINER MAAS
K130806 07/12/2013 NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE NEUROVISION MEDICAL PRODUCTS, INC. CHRISTINE VERGELY
K130399 07/18/2013 CERTUS 140 CERTUSURGGT SURGICAL TOOL NEUWAVE MEDICAL, INC. DAN KOSEDNAR
K130879 07/09/2013 NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUS NEXUS MEDICAL, LLC HEATHER TURNER
K131417 07/12/2013 FACET FIXX NEXXT SPINE LLC KAREN E WARDEN PHD
K131542 07/24/2013 NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC NOVABAY PHARMACEUTICALS, INC PATSY J TRISLER
K124062 07/10/2013 QDC-PRO, AND NOX-RIP NOX MEDICAL KOLBRUN E OTTOSDOTTIR
K131238 07/02/2013 AFFIX SPINOUS PROCESS PLATE SYSTEM NUVASIVE, INC. SHEILA BRUSCHI
K130460 07/11/2013 NXSTAGE DOSING CALCULATOR NXSTAGE MEDICAL, INC. NNAMDI NWACHUKWU
K131742 07/24/2013 HEM-6131 OMRON HEALTHCARE, INC. PAUL DRYDEN
K130656 07/03/2013 IFUSION OPTOVUE, INC. WILLIAM "BILL" JACKSON
K130920 07/02/2013 CORRECT PLUS 1 PENTRON CLINICAL WENDY GARMAN
K122402 07/16/2013 LPP (LOW PROFILE PORT) PFM MEDICAL, INC SALVADORE PALOMARES, RAC
K131738 07/10/2013 IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H PHADIA AB CARINA MAGNUSSON
K130553 07/03/2013 ABSOCLEAR PHARMAPLAST S.A.E. CYNTHIA PRITCHARD
K132087 07/24/2013 PERCUNAV SYSTEM PHILIPS HEALTHCARE DAVE SZCZUPAKOWSKI
K123599 07/12/2013 INGENUITY DIGITAL PET/CT PHILIPS HEALTHCARE (CLEVELAND) MICHAEL S PRETO
K131263 07/24/2013 XPERGUIDE PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. JOS V VROONHOVEN
K130353 07/01/2013 PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION) PIPELINE ORTHOPEDICS TERRY POWELL
K130667 07/24/2013 POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL PREVENTIVE CARE, INC. ANIL SEGAT
K130442 07/03/2013 NEWTOM VGI AND NEWTOM 5G QR S.R.L. BERTHOIN CLAUDE
K123983 07/03/2013 FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS QUALIGEN, INC. MICHAEL S POIRIER
K131081 07/03/2013 CYBER TM FAMILY QUANTA SYSTEM SPA MAURIZIO BIANCHI
K130256 07/02/2013 MDK MULTI-APPLICATIONS PLATFORM QUANTA SYSTEM SPA MAURIZIO BIANCHI
K131606 07/05/2013 SOFIA INFLUENZA A+B FIA QUIDEL CORP. JOHN D TAMERIUS, PH.D.
K131599 07/05/2013 QUICK VUE INFLUENZA QUIDEL CORPORATION JOHN D TAMERIUS, PH.D.
K130962 07/24/2013 R&D 5D RETIC HEMATOLOGY CONTROL R & D SYSTEMS, INC. AMBREEN ATHAR
K130144 07/31/2013 ABL90 FLEX RADIOMETER MEDICAL APS MARTIN GABLER
K131776 07/18/2013 ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3 RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K131999 07/26/2013 HBA1C CONTROL, LEVEL 1 AND LEVEL 2 RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K130935 07/02/2013 DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA RAYENCE CO., LTD DAVE KIM
K130079 07/19/2013 MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER REFLECTANCE MEDICAL INC NANDINI MURTHY
K131087 07/12/2013 SHARPSTANK REUSABLE SHARPS CONTAINER REHRIG PACIFIC COMPANY DAVID OLMSTEAD
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