FDA 510(k) Decisions During June, 2013  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K130185 06/07/2013 4WEB OSTEOTOMY BONE WEDGE 4-WEB, INC. RICH JANSEN, PHARM, D.
K130664 06/21/2013 HYRDROMAX HMEF A-M SYSTEMS PAUL DRYDEN
K130094 06/27/2013 FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM ABBOTT DIABETES CARE DAVID G LAMBERT
K122449 06/13/2013 ENTERAL NUTRITION WARMER ACACIA, INC. FERGIE FERGUSON
K131300 06/07/2013 THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER ACCESS SCIENTIFIC, LLC ALBERT MISAJON
K123354 06/28/2013 REVITIVE IX Actegy Ltd JOHN J SMITH
K131380 06/10/2013 ACUMED TOTALW RIST FUSION PLATING SYSTEM ACUMED LLC BRITTANY CUNNINGHAM
K122809 06/17/2013 ADVIN MULTI-DRUG SCREEN TEST CASSETTE, DIP CARD AND CUP ADVIN BIOTECH EDWARD TUNG
K122791 06/04/2013 LYOPLANT ONLAY AESCULAP, INC. DENISE ADAMS
K112598 06/20/2013 AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) AMERICAN SURGICAL COMPANY, LLC MICHAEL ALOUANE
K121642 06/06/2013 WIZARD 230 NASAL PILOW MASK APEX MEDICAL CORP. FRANK LIN
K130050 06/18/2013 TITAN REVERSE SHOULDER SYSTEM ASCENSION ORTHOPEDIC SUSAN WALTON
K121101 06/20/2013 SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT ASTORIA-PACIFIC,INC. CHARLES A PETERSON
K121343 06/14/2013 MODULAP LOOP ATC TECHNOLOGIES, INC. JOHN GILLESPIE
K121214 06/14/2013 ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM BECKMAN COULTER, INC. KERRIE OETTER
K123404 06/27/2013 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML) BECTON, DICKINSON & CO. MONICA E GIGURERE
K123266 06/26/2013 BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN Becton, Dickinson and Company MONICA E GIGUERE
K124038 06/21/2013 BEDSIDE PAEDIATRIC EARLY WARNING SYSTEM (BEDSIDEPEWS) BEDSIDE CLINICAL SYSTEMS INC DIANE SUDDUTH
K121284 06/14/2013 CHABNER XRT GARMENTS BFFL CO. INC EVAN P PHELPS
K130944 06/07/2013 ISR'OBOT MONA LISA BIOBOT SURGICAL PTE LTD JOHN BABY
K130914 06/21/2013 FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL BIOFIRE DIAGNOSTICS, INC. BETH LINGENFELTER
K122979 06/04/2013 VIDAS LYME IGM BIOMERIEUX SA CATHERINE FRITSCH
K130310 06/21/2013 CERTAIN BELLATEK PROVISIONAL ABUTMENTS BIOMET 3I JACQUELYN A HUGHES, RAC
K130309 06/17/2013 RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM BIOMET MICROFIXATION CHRISTINE SCIFERT
K130298 06/18/2013 BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM BIOPRO, INC. AL LIPPINCOTT
K123559 06/28/2013 SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM Biotest Medical Corp. FRED LEE
K123653 06/03/2013 SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED) BISCO, INC. Michelle Schiltz-Taing
K130382 06/05/2013 HEARTSTRING III PROXIMAL SEAL SYSTEM Boston Scientific Corporation MARK DINGER
K123810 06/14/2013 PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM CARBOFIX ORTHOPEDICS LTD. YAEL RUBIN
K130927 06/18/2013 DURABLUE STERILIZATION WRAP CARDINAL HEALTH 200, LLC LAVENIA FORD
K131092 06/24/2013 STEALTH 360 ORBITAL PAD SYSTEM CARDIO SYSTEMS, INC. MAUREEN MCDONNELL
K130567 06/11/2013 DR LONG LENGTH IMAGING SOFTWARE CARESTREAM HEALTH, INC. CAROLYN WAGNER
K130464 06/07/2013 CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR CARESTREAM HEALTH,INC. CAROLYN WAGNER
K130549 06/26/2013 INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR CARL ZEISS MEDITEC INC SARAH HARRINGTON
K130894 06/20/2013 XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE CEPHEID RAINER ZIERMANN PH.D.
K131303 06/11/2013 DISPOSABLE CIRCULAR STAPLER CHANGZHOU CITY ZHIYE MEDICAL DEVICES INSTITUTE CO. CHARLIE MACK
K123427 06/28/2013 NIRVANA D PERSONAL LUBRICANT (TBD) CHURCH & DWIGHT CO., INC. EMILY PEREZ
K131005 06/25/2013 EBA2 FEMORAL NAILING SYSTEM CITIEFFE S.R.L. CLAUDE BERTHION
K131528 06/11/2013 NON-PYROGENIC ULTRASOUND TRANSDUCER COVER CIVCO MEDICAL INSTRUMENTS CO., INC. AMANDA STAHLE
K131443 06/19/2013 COALIGN INNOVATIONS ACCULIF XL IBF CAGE COALIGN INNOVATIONS, INC. JUSTIN EGGLETON
K120892 06/10/2013 DISPOSABLE 330PSI EXTENSION LINES COEUR, INC. DEBRA F MANNING
K123481 06/06/2013 AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE CONVATEC INC KATRINA FIEDLER
K122917 06/28/2013 CODA BALLOON CATHETER COOK, INC. ELYSIA EASTON
K123394 06/06/2013 CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING CORELEADER BIOTECH CO., LTD. VINCENT HUANG
K121436 06/06/2013 DAS MEDICAL EQUIPMENT DRAPES DAS MEDICAL, LLC ARMOND GROVES
K124018 06/14/2013 AMIA AUTOMATED PD SYSTEM DEKA RESEARCH & DEVELOPMENT CORP. ROGER A LEROUX
K131683 06/27/2013 HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM) DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY KRISTINE CHRISTO
K130912 06/14/2013 OMNICUT RESECTION BLADE DEPUY MITEK, A JOHNSON & JOHNSON COMPANY TATYANA KORSUNSKY
K131556 06/26/2013 DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET DIAZYME LABORATORIES Abhijit Datta
K123785 06/07/2013 DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET DIAZYME LABORATORIES Abhijit Datta
K130722 06/20/2013 AIRCAST VENAFLOW ELITE SYSTEM DJO, LLC LORRI TROTTER
K123431 06/17/2013 DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D DREAMCON CO., LTD ALBERT REGO
K120727 06/21/2013 MFM-CMS CENTRAL MONITORING SYSTEM EDAN INSTRUMENTS INC RANDY JIANG
K130099 06/21/2013 TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019 ENCORE MEDICAL, L.P. WILLIAM GARZON
K122820 06/18/2013 VIKY UP ENDOCONTROL HUGUEL CARINE
K122748 06/11/2013 ENGLER 25K SERIES ULTRASONIC INSERTS ENGLER ENGINEERING CORP. JOEL KATZ
K130503 06/11/2013 PATHASSIST LED LIGHT FIBER Entellus Medical, Inc. KAREN E PETERSON
K121628 06/25/2013 EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI) EPI MOBILE HEALTH SOLUTIONS (S) PTE LTD KARL M NOBERT
K123261 06/12/2013 EUROIMMUN ANTI-NRNP/SM ELISA (IGG) EUROIMMUN US KATHRYN KOHL
K131153 06/18/2013 EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP EVENFLO FEEDING INCORPORATED WADE HALMA
K130328 06/05/2013 F&P SIMPLUS FULL FACE MASK FISHER & PAYKEL HEALTHCARE LIMITED SUE CHO
K130507 06/03/2013 FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER FOOTPRINT MEDICAL INC. CLYDE N BAKER
K130542 06/14/2013 SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS FUJIFILM MEDICAL SYSTEM U.S.A., INC. JYH-SHYAN LIN
K131267 06/19/2013 VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10 GE HEALTHCARE BRYAN BEHN
K123144 06/18/2013 VIVO 50 GE HEALTHCARE, BREAS MEDICAL AB SHLOMI DELER
K130584 06/26/2013 MONITOR B40 GE MEDICAL SYSTEMS CHINA CO., LTD. CASARSA ROBERT
K131395 06/19/2013 TRANSTEK BLOOD PRESSURE MONITOR GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD LEO WANG
K130191 06/12/2013 MINT HANSBIOMED CORPORATION APRIL LEE
K130563 06/18/2013 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR HEALTH & LIFE CO., LTD. SARAH SU
K130564 06/19/2013 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR HEALTH & LIFE CO., LTD. SARAH SU
K122473 06/03/2013 TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 HILL-ROM ANN WATERHOUSE
K123627 06/28/2013 ET SMARTFIT ABUTMENT HIOSSEN INC. PATRICK LIM
K120945 06/07/2013 HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST HITACHI CHEMICAL DIAGNOSTICS, INC. CHARLES TSOU
K131051 06/07/2013 HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) HITACHI CHEMICAL DIAGNOSTICS, INC. ERIKA AMMIRATI
K131217 06/07/2013 S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN HITACHI CHEMICAL DIAGNOSTICS, INC. CHARLES TSOU
K130397 06/20/2013 ARROW GPSCATH BALLOON DILATATION CATHETER HOTSPUR TECHNOLOGIES ERIC ANKERUD, JD
K130008 06/25/2013 DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING I.T.S. GMBH AL LIPPINCOTT
K123253 06/18/2013 IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D IMMUNODIAGNOSTIC SYSTEMS LTD. MICK FENTON
K130295 06/21/2013 LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM. INFOPIA CO., LTD Priscilla Chung
K130598 06/05/2013 INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER INSPIRX, INC. PAUL DRYDEN
K130290 06/04/2013 MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE INTEL-GE CARE INNOVATIONS LLC MAUREEN GLYNN
K130795 06/20/2013 TITAN INTERACOUSTICS A/S ERIK NIELSEN
K131131 06/21/2013 E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM INTROMEDIC CO., LTD STEVE KWON
K130726 06/07/2013 DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK INTUITIVE SURGICAL, INC. MELISSA S GONZALEZ
K123158 06/21/2013 ION MAGNUM GENIUS ION GENIUS INC XANYA SOFRA-WEISS
K122521 06/11/2013 PREVENT SEAL ITENA CLINICAL LOUIS-PAUL MARIN
K122551 06/14/2013 PROVITEMP ITENA CLINICAL LOUIS-PAUL MARIN
K131291 06/14/2013 TORC BODY JOHARI DIGITAL HEALTHCARE, LTD. POOJA JOHARI
K122983 06/26/2013 KSEA BIPOLAR ELECTRODE KARL STORZ ENDOSCOPY-AMERICA, INC. WINKIE WONG
K131589 06/27/2013 KEELER SLIT LAMP H-SERIES KEELER LTD. NICKIE POWER
K122653 06/26/2013 MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES KIMBERLY-CLARK CORPORATION DAVID LEE
K130599 06/05/2013 WART FREEZE KONINKLIJKE UTERMOHLEN NV KENNETH R MICHAEL
K131568 06/28/2013 SUDO PATH LD TECHNOLOGY LLC ALBERT MAAREK
K130630 06/13/2013 PLATEAU SPACER SYSTEM TITANIUM LIFE SPINE, INC RANDY LEWIS
K123842 06/24/2013 LAWMAX DILATOR LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. LILY SHI
K131112 06/07/2013 LIMACORPORATE SMR CTA HUMERAL HEADS LIMACORPORATE S.P.A. CHERYL HASTINGS
K130642 06/12/2013 SMR 3-PEGS GLENOIDS LIMACORPORATE S.P.A. CHERYL HASTINGS
K121481 06/25/2013 INFINI RADIOFREQUENCY SYSTEM LUTRONIC CORPORATION JHUNG WON VOJIR
K123127 06/14/2013 VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 MAINE STANDARDS CO. JAMES W CHAMPLIN
K123288 06/26/2013 HEMOCONCENTRATOR MAQUET CARDIOPULMONARY AG INGRID RICHTER
K123292 06/11/2013 T3 MEDCOMP TIMOTHY HOLWICK
K122973 06/12/2013 AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE MEDGYN PRODUCTS, INC. STEPHANIE BLAIR
K124046 06/03/2013 VALVED TEARAWAY INTRODUCER GENERATION II MEDICAL COMPONENTS INC TIMOTHY HOLWICK
K130877 06/20/2013 EXPEDIUM SPINE SYSTEM MEDOS INTERNATIONAL SARL KIRSTEN LEHMULLER
K131321 06/05/2013 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA LAUREN KAMER
K130640 06/04/2013 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. KRISTI FRISCH
K123423 06/05/2013 ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT MERIDIAN BIOSCIENCE, INC. Michelle L Smith
K130566 06/19/2013 BASIXTOUCH MERIT MEDICAL SYSTEMS, INC. DAN W LINDSAY
K130259 06/07/2013 BEARING NSPVA EMBOLIZATION PARTICLES MERIT MEDICAL SYSTEMS, INC. LINDA VARROSO
K130791 06/07/2013 PRELUDE SHEATH INTRODUCER MERIT MEDICAL SYSTEMS, INC. MICHAELA RIVKOWICH
K123007 06/19/2013 VERI-Q MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM, VERI-Q PLUS MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM MICOBIOMED CO, LTD Priscilla Chung
K123016 06/18/2013 VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS MICOBIOMED CO, LTD Priscilla Chung
K123518 06/05/2013 ABBOTT CARBAMAZEPINE ASSAY Microgenics Corporation KAREN LEE
K131346 06/06/2013 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K130577 06/17/2013 AZUR PUSHABLE 18 & 35 SYSTEM MICROVENTION, INC. CYNTHIA VALENZUELA
K131115 06/07/2013 ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIRE NDS SURGICAL IMAGING JIM LENG
K130816 06/21/2013 INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE) NEURO RESOURCE GROUP, INC. DAVID TURNER
K122503 06/25/2013 PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON NEURO THERM, INC. F. DAVID ROTHKOPF
K130774 06/19/2013 UNIVERSAL DISTAL RADIUS SYSTEM NEWCLIP TECHNICS J.D. WEBB
K130416 06/12/2013 NEXUS TKO-6P LUER ACTIVATED DEVICE NEXUS MEDICAL, LLC HEATHER TURNER
K120954 06/05/2013 NOBELPROCERA PEEK ABUTMENTS NOBEL BIOCARE AB PHUONG NGUYEN SON
K131509 06/28/2013 ZOE FLUID STATUS MONITOR NONINVASIVE MEDICAL TECHNOLOGIES, INC. MARC O'GRIOFA
K130995 06/14/2013 NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY NUANCE MEDICAL, LLC MARC S LIEBERMAN
K130281 06/21/2013 OAK RIDGE PRODUCTS SHARP CONTAINER OAK RIDGE PRODUCTS, LLC TIBOR B KOVARI
K130819 06/19/2013 CLL- V1 LIGHT SOURCE OLYMPUS WINTER & IBE GMBH SHERI L MUSGNUNG
K131181 06/25/2013 OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE OMEGA LABORATORIES, INC. ROBERT J BARD, JD, RAC, CQE
K121902 06/06/2013 NATRATONE ORELLE CORPORATION LTD PATRICIA COOMBES
K120931 06/06/2013 CRITICAL CARE VENTILATOR ORICARE, INC. DAVID JAMISON
K122588 06/12/2013 VUSION CS PLUS ORTHO DEVELOPMENT CORP. TOM HAUETER
K130446 06/07/2013 FASTBRACES CERAMIC BRACKETS ORTHODONTIC DESIGN AND PRODUCTION, INC. RICHARD MERRELL
K124023 06/10/2013 STARBAND ORTHOMERICA PRODUCTS, INC. DAVID L HOOPER
K130217 06/20/2013 ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM ORTHOPEDIATRICS, CORP. MARK FOX
K130380 06/13/2013 ORTHOSENSOR KNEE BALANCER ORTHOSENSOR, INC. KIMBERLEE WASHBURN
K130104 06/13/2013 GUIDEWIRE, PURSUER SERIES Oscor Inc. MILA DOSKOCIL
K131445 06/18/2013 OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM OSTEOMED LP BLESSON ABRAHAM
K123885 06/03/2013 OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR OSTEOMED LP PIEDAD PENA
K130443 06/14/2013 I-MAX TOUCH 3D OWANDY Claude Berthoin
K131141 06/27/2013 EARPROBE PATH MEDICAL GMBH JOHANN OSWALD
K122997 06/26/2013 23GA CURVED ILLUMINATING LASER PROBE PEREGRINE SURGICAL LTD. RYAN O'LEARY
K123275 06/28/2013 IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM PHADIA AB MARTIN MANN
K123576 06/07/2013 IMR SOFTWARE APPLICATION PHILIPS HEALTHCARE (CLEVELAND) CHRISTINE ANDERSON
K130638 06/28/2013 ALLURACLARITY XPER FD SERIES X-RAY SYSTEM PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. KLIEN VAN DAM
K130992 06/14/2013 PINNACLE3 RADIATION THERAPY PLANNING SYSTEM PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. DIANE SUDDUTH
K130849 06/14/2013 INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN MARKUS STACHA
K130499 06/18/2013 IU22 DIAGNOSTIC ULTRASOUND SYSTEM PHILIPS ULTRASOUND, INC. JESSICA STENBERG
K130790 06/27/2013 LYRIC2 PHONAK LLC JOHN J SMITH
K124012 06/04/2013 INFILL OBLIQUE TLIF DEVICE PINNACLE SPINE GROUP, LLC Rebecca K Pine
K131100 06/27/2013 STREAMLINE TL SPINAL SYSTEM PIONEER SURGICAL TECHNOLOGY, INC SARAH MCINTYRE
K130427 06/05/2013 PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM PIONEER SURGICAL TECHNOLOGY, INC. SARAH MCINTYRE
K131237 06/13/2013 PIPELINE TOTAL HIP SYSTEM PIPELINE ORTHOPEDICS TERRY POWELL
K131543 06/20/2013 TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED PROCTER & GAMBLE CO. KATHLEEN BLIESZNER
K131524 06/23/2013 PROTEUS PATCH INCLUDING INGESTIBLE SENSOR PROTEUS DIGITAL HEALTH, INC. ZAHEDEH HATAMKHANY
K130487 06/25/2013 FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE PYNG MEDICAL CORP. Michele Tyler
K130787 06/13/2013 QUANTUM DENTAL IMPLANT SYSTEM QUANTUM BIOENGINEERING, LTD. LINDA SCHULZ
K131619 06/28/2013 QUICKVUE INFLUENZA A+B QUIDEL CORP. JOHN D TAMERIUS
K123793 06/17/2013 SOFIA STREP A FIA QUIDEL CORPORATION JOHN D TAMERIUS, PH.D.
K131329 06/06/2013 VECTOR PTA BALLOON DILATATION CATHETER R4 VASCULAR, INC. LAURIE LEWANDOWSKI
K130337 06/19/2013 RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3 RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG
K130773 06/05/2013 TEMPUS PRO PATIENT MONITOR REMOTE DIAGNOSTIC TECHNOLOGIES LTD. CHRIS HANNAN
K130002 06/28/2013 SURECALL LABOR MONITOR REPRODUCTIVE RESEARCH TECHNOLOGIES, LP J. HARVEY KNAUSS
K122715 06/17/2013 STELLAR 150 RESMED GERMANY INC. JIM CASSI
K131287 06/24/2013 CARDIOSLEEVE RIJUVEN CORP E.J. Smith
K123106 06/20/2013 DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A SAMSUNG ELECTRONICS CO., LTD. CHARLIE MACK
K123105 06/07/2013 XGEO GU60 SAMSUNG ELECTRONICS CO., LTD. CHARLIE MACK
K122567 06/19/2013 JOULE 810/940/980 MULTI-PLATFORM SYSTEM SCITON, INC. JAY M PATEL
K131654 06/27/2013 STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER SENORX, INC. SARAH MCCARTNEY
K130015 06/13/2013 SHASER V-MINI HAIR REMOVAL SYSTEM SHASER, INC. SARAH HACKETT
K130833 06/21/2013 DP-20 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM; DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN
K130695 06/19/2013 Z5 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD WU ZICUI
K131569 06/14/2013 PG-800A SERIES SHENZHEN PANGO ELECTRONIC CO., LTD Diana Hong
K130739 06/06/2013 ACUSON S2000 AND S3000 DIAGNOSTIC ULTRASOUND SYSTEMS SIEMENS MEDICAL SOLUTIONS USA, INC. SHELLY PEARCE
K123520 06/11/2013 MAMMOMAT INSPIRATION PRIME SIEMENS MEDICAL SOLUTIONS USA, INC. PATRICIA D JONES
K123598 06/28/2013 SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION SMITH & NEPHEW, INC. Bradley Heil
K130193 06/14/2013 FRAXEL DIAL 1550/1927 LASER SYSTEM SOLTA MEDICAL, INC. Raymond Lee
K130025 06/11/2013 SONENDO ENDOTHERAPY SYSTEM SONENDO, INC. DAN W MILLER
K130801 06/14/2013 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM SONOSCAPE COMPANY LIMITED TOKI WU
K131213 06/21/2013 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM SONOSCAPE COMPANY LIMITED TOKI WU
K131103 06/06/2013 XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR SORIN GROUP ITALIA S.R.L. SCOTT LIGHT
K130279 06/20/2013 REFORM PEDICLE SCREW SYSTEM SPINAL USA MEREDITH MAY
K130545 06/18/2013 MULTI LEAD TRIAL CABLE ST. JUDE MEDICAL Lakshmi Padmanabhan
K122365 06/04/2013 ULTRACHECK CURVE BLOOD PRESSURE CUFFS STATCORP MEDICAL WAYNE EMMERT
K130724 06/28/2013 CODIAGNOSTIX IMPLANT PLANNING SOFTWARE STRAUMANN USA ELAINE ALAN
K130808 06/28/2013 STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS STRAUMANN USA ELAINE ALAN
K123843 06/05/2013 NEUROEPG SYSTEM STROHL MEDICAL TECHNOLOGIES JIM GRECO
K130907 06/10/2013 HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM Stryker Trauma AG ESTELA CELI
K121920 06/27/2013 LASERBRUSH SUNETICS INTERNATIONAL MARKETING GROUP, LLC JOHN CARULLO
K131314 06/25/2013 DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM) SWISSRAY MEDICAL AG TODD SHOPP
K130902 06/14/2013 EMORY CARDIAC TOOLBOX 3.2 SYNTERMED, INC. KENNETH VAN TRAIN
K131193 06/18/2013 ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM TACTILE SYSTEMS TECHNOLOGY INC DAVE HALVERSON
K121045 06/19/2013 HUMAN ALBUMIN CSF KIT THE BINDING SITE GROUP, LTD. JILL CONSTANTINE
K122965 06/03/2013 HUMAN CAERULOPLASMIN KIT THE BINDING SITE GROUP, LTD. JILL CONSTANTINE
K122950 06/14/2013 LASER HELMET THERADOME INC. LARRY PETERSEN
K130850 06/25/2013 PRIMI AND SECONDI SUPPORT CATHETERS THERMOPEUTIX INC. JASON FORD
K123101 06/05/2013 TRC-50DX RETINAL CAMERA TOPCON MEDICAL SYSTEMS, INC. MAUREEN O'CONNELL
K130645 06/06/2013 AQUILION PRIME, V5.00 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
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