FDA 510(k) Decisions During August, 2013  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K131707 08/22/2013 3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS 3B MEDICAL, INC ALEX LUCIO
K132365 08/20/2013 SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION ACCEL SPINE AEKTA PATEL
K122553 08/05/2013 MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM ACON LABORATORIES, INC. QIYI XIE
K131052 08/16/2013 TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS) ACTUATED MEDICAL, INC. DEBORA DEMERS, PH.D.
K130627 08/21/2013 SWING-OFF SCREW ADVANCED INTERVENTIONAL TECHNOLOGY, LLC EDUARDO MARCH
K130165 08/30/2013 PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0 ADVANCED PLANIMETRIC SERVICES, LLC MARTIN WENDELKEN
K130887 08/13/2013 S4C NAVIGATION INSTRUMENTS AESCULAP IMPLANT SYSTEM, INC. LISA M BOYLE
K123882 08/14/2013 AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR AGELESS HEALTH INDUSTRIAL VICTOR WAN
K131408 08/29/2013 CR 12-X DIGITIZER AGFA HEALTHCARE N.V. SHAEANN CAVANAGH
K131313 08/07/2013 ACTIVE BREATHING COORDINATOR AKTINA MEDICAL CORP. TONY SPACCAROTELLA
K131515 08/14/2013 ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT ALFA WASSERMANN HYMAN KATZ, PH.D.
K131351 08/15/2013 ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC HYMAN KATZ
K131488 08/19/2013 ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC HYMAN KATZ
K123834 08/13/2013 EASYSTAND BANTAM MEDIUM ALTIMATE MEDICAL, INC. STACEY FRANK
K131144 08/15/2013 AMECO SHEATH INTRODUCER AMECO MEDICAL INDUSTRIES RAYMOND J KELLY
K123699 08/12/2013 FAHL TRACHEOSTOMY TUBES (MULTIPLE) ANDREAS FAHL MEDIZINTECHNIK-VERTRIEB GMBH CLAUDIA WINTERSCHLADEN
K131049 08/27/2013 ZRP APEX DENTAL MATERIALS, INC. CHRIS KULTON
K132263 08/19/2013 AXERA 2 ACCESS SYSTEM ARSTASIS, INC. DEBRA COGAN
K132099 08/22/2013 ARTHROCARE COBLATOR IQ DLR SPINEWAND, ARTHROCARE COBLATOR IQ DLG SPINEWAND ARTHROCARE CORPORATION SHIRLEY HYINK
K131205 08/09/2013 ARTHROCARE HEAD AND NECK COBLATION WAND ARTHROCARE CORPORATION MITCHELL A DHORITY
K131360 08/07/2013 INTEGRA TITANIUM BONE WEDGE ASCENSION ORTHOPEDIC KYLA KARA
K130693 08/14/2013 AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM ASEPTICO, INC. CHERIE TREGONING
K131842 08/20/2013 STERICAN CANNULA B. BRAUN MEDICAL, INC. KIMBERLY SMITH
K132374 08/30/2013 BAYLIS MEDICAL RF PERFORATION PROBE V2.0 BAYLIS MEDICAL COMPANY INC. MEGHAL KHAKHAR
K131301 08/02/2013 BD FACS SAMPLE PREP ASSISTANT III BECTON DICKINSON & CO. KIMBERLY LIEDTKE
K130268 08/23/2013 BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO. EMILY HOWARD
K132256 08/07/2013 BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B BECTON, DICKINSON AND COMPANY GREGORY P PAYNE, RAC
K132259 08/07/2013 BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B BECTON, DICKINSON AND COMPANY GREGORY P PAYNE, RAC
K123061 08/13/2013 ACE MONOPOLAR ATTACHMENT BIOECONEER INC. MICHAEL LEE
K131930 08/05/2013 JBAIDS ANTHRAX DETECTION KIT BIOFIRE DIAGNOSTICS, INC. CYNTHIA PHILLIPS
K123947 08/29/2013 ARCHITECT IVANCOMYCIN BIOKIT S.A. GUILLEM ANGLERILL
DEN130013 08/21/2013 VITEK MS BIOMERIEUX, INC. Nancy Weaver
K124067 08/21/2013 VITEK MS BIOMERIEUX, INC. NANCY WEAVER
K130033 08/01/2013 TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO BIOMET MANUFACTURING CORP. ELIZABETH WRAY
K131674 08/08/2013 PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING BIOMET MICROFIXATION ELIZABETH WHEELER
K130126 08/06/2013 SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM BIOMET, INC. TRACY B JOHNSON
K130610 08/30/2013 SIRIUS FEMORAL STEM BIOMET, INC. BECKY EARL
K131221 08/28/2013 LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/400 BIOMONDE ROSINA ROBINSION, RN, MED, RAC
K130716 08/28/2013 BIORETEC ACTIVASCREW INTERFERENCE BIORETEC LTD MARI RUOTSALAINEN
K130602 08/14/2013 LASSO NAV DUO LOOP CATHETER BIOSENSE WEBSTER, INC. JOHN JIMENEZ
K131978 08/23/2013 SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL BIOTRONIK, INC. JON BRUMBAUGH
K130484 08/09/2013 MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER BOSTON SCIENTIFIC CORP. ANDREW NGUYEN
K123047 08/06/2013 BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET BRACCO DIAGNOSTIC, INC. TRACEY ALEXANDER
K130792 08/30/2013 LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM C.R. BARD, INC. CHRISTOPH WAGNER VON HOFF
K131493 08/02/2013 SIDEKICK AND USHER SUPPORT CATHETERS C.R. BARD, INC. TIMOTHY WADE
K131523 08/22/2013 CRYOBALLOON FOCAL ABLATION SYSTEM C2 THERAPEUTICS PETER GARCIA-MEZA
K131101 08/26/2013 ITERO SOFTWARE CADENT, LTD. AN ALIGN TECHNOLOGY COMPANY MANAS M LELE
K123443 08/13/2013 PRECISE SHP DIODE LASER CAO GROUP, INC. ROBERT K LARSEN
K131538 08/08/2013 CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM CAPTIVA SPINE RICH JANSEN
K123571 08/01/2013 CARDIO VISION MICS AORTIC CLAMPS CARDIOMEDICAL GMBH ANGELIKA SCHERP
K132413 08/29/2013 MZ1000 CAREFUSION MICHELLE J BADAL, RAC
K130027 08/22/2013 DISPOSABLE NEUTRAL ELECTRODE GP202 CATHAY MANUFACTURING CORP. ZHANG HUI
K131325 08/16/2013 QUATTRO GL SUTURE ANCHOR CAYENNE MEDICAL, INC. KERESHMEH SHAHRIARI
K130752 08/15/2013 DYNASENSE SYSTEM CENTAURI MEDICAL, INC. LORI ADELS
DEN130005 08/08/2013 QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS CENTERS FOR DISEASE CONTROL AND PREVENTION ELIZABETH HAMELIN
K122282 08/08/2013 QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS CENTERS FOR DISEASE CONTROL AND PREVENTION ELIZABETH HAMELIN
K130461 08/28/2013 STALIF X CENTINEL SPINE INC. JUSTIN EGGLETON
K131305 08/01/2013 CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE CHISON MEDICAL IMAGING CO., LTD. BOB LEIKER
K123436 08/26/2013 FIRST RESPONSE EARLY RESULT PREGNANCY TEST CHURCH & DWIGHT CO., INC. JOSEPH CICCONE
K131363 08/30/2013 ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM CILAG GMBH INTERNATIONAL OYINKAN DONALDSON
K130046 08/06/2013 CLEARSPEC SINGLE USE VAGINAL SPECULUM CLEARSPEC LLC IRA DUESLER
K132281 08/30/2013 REVASC THROMBECTOMY DEVICE CODMAN & SHURTLEFF, INC. AMARILYS MACHADO
K132061 08/02/2013 RESTORELLE M, RESTORELLE XL COLOPLAST CORP. TIM CRABTREE
K130137 08/23/2013 BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER COLTENE/WHALEDENT EDWARD A KROLL
K131198 08/27/2013 TIPI OTC CONTIPI LTD. JONATHAN KAHAN
K132334 08/16/2013 TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET COOK, INC. SEAN SPENCE
K131378 08/30/2013 SUS (STENFILCON A) CONTACT LENS COOPERVISION, INC. ANNETTE NELSON
K131522 08/09/2013 CORE PEDICLE SCREW SYSTEM CORE-NEXUS LISA PETERSON
K131532 08/12/2013 ELECTROMAGNETIC TRANSMITTING STYLET CORPAK MEDSYSTEMS STEPHANIE WASIELEWSKI
K123756 08/16/2013 COVAGEN COVALON TECHNOLOGIES LTD. CHRISTOPHER FREDRIC
K132360 08/27/2013 KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER COVIDIEN ASHLEY GONCALO
K131614 08/29/2013 REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM COVIDIEN DANIEL CAMPION
K131170 08/28/2013 SONICISION STERILIZATION TRAY COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE DAVID HORTON
K131079 08/01/2013 CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC CREGANNA MEDICAL DEVICES CHRISTINE NICHOLS
K130089 08/09/2013 CROSSTREES PVA POD CROSSTREES MEDICAL, INC. JANICE M HOGAN
K123830 08/16/2013 INTERMITTENT PNEUMATIC COMPRESSION DEVICE DALIAN LABTEK SCIENCE & DEVELOPMENT CO., LTD. DORIS DONG
K131945 08/08/2013 GE DATEX-OHMEDA AVANCE CS2 DATEX-OHMEDA JAMES P RASKOB
K130244 08/23/2013 DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM DELBIO INCORPORATION NICKY PAN
K131197 08/27/2013 EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS DENTAL MORELLI TARA CONRAD
K130814 08/01/2013 RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM DEPUY MITEK, A JOHNSON & JOHNSON COMPANY KRISTINE CHRISTO
K131464 08/13/2013 EXTRICARE NPWT FOOT DRESSING DEVON MEDICAL INC. RUTH WU
K130779 08/15/2013 LVIVO EF SYSTEM DIACARDIO, LTD GEORGE HATTUB
K130163 08/16/2013 D-LUX DIADENT GROUP INTERNATIONAL GIL JUN, HONG
K131441 08/09/2013 LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II DIASORIN, INC. SANDRA ZIMNIEWICZ
K132234 08/28/2013 LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II DIASORIN, INC. JOHN ESKDALE
K122562 08/09/2013 E-TENG MODEL EOR 1 E-TENG TECHNOLOGY, INC. JUNNATA CHANG
K131818 08/30/2013 VITAL SIGNS MONITOR EDAN INSTRUMENTS, INC. QUEENA CHEN
K131376 08/27/2013 SMARTCOAT 2.5% NAF VARNISH ELEVATE ORAL CARE STEVE PARDUE
K130301 08/22/2013 LATEX SURGEON'S GLOVES (POWDERED AND POWDER FREE) ELIMEDICAL DEVICES (FUJIAN) INC. DIANA HONG
K131949 08/26/2013 AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES ENCISION, INC. JIM LEWIS
K132535 08/23/2013 AUTOBAND LIGATOR ENDOCHOICE, INC. DANIEL HOEFER
K130793 08/16/2013 NEWA SKIN THERAPY SYSTEM ENDYMION MEDICAL LTD YORAM LEVY
K130900 08/13/2013 EVICEL APPLICATION DEVICE ETHICON INC (ON BEHALF OF OMRIX BIOPHARACEUTICALS LTD) SHIKHA GOLA
K132054 08/23/2013 GYNECARE TVT EXACT CONTINENCE SYSTEM ETHICON, INC. SUSAN LIN
K131616 08/29/2013 EZ3D-I, E3 EWOO SOFT CO., LTD DAVE KIM
K131594 08/29/2013 EZDENTI-I; E2; PRORA VIEW EWOO SOFT CO., LTD DAVE KIM
K131570 08/15/2013 ORTHOVISION EWOO SOFT CO., LTD DAVE KIM
K122337 08/06/2013 OVUSENSE FERTILITY FOCUS LTD PENNY NORTHCUTT
K131657 08/22/2013 FLOWER SMALL AND MEDIUM IMPLANT SET FLOWER ORTHOPEDICS CORPORATION JANICE M HOGAN
K131875 08/06/2013 MENICON NECT CONTACT LENS CASE FORESIGHT REGULATORY STRATEGIES ELLEN M BEUCLER
K131611 08/29/2013 FRESENIUS DRY ACID DISSOLUTION UNITS FRESENIUS MEDICAL CARE NORTH AMERICA DENISE OPPERMANN
K123814 08/13/2013 HUMELOCK II CEMENTED SHOULDER SYSTEM FX SOLUTIONS JEAN-JACQUES MARTIN
K122627 08/22/2013 GIO DIGITAL PRESSURE GUAGES GALEMED CORP. TOM SHANKS
K131527 08/26/2013 LOGIQ S8 GE HEALTHCARE BRYAN BEHN
K131223 08/28/2013 CARESCAPE MONITOR B650 GE HEALTHCARE FINLAND OY JOEL KENT
K131414 08/28/2013 CARESCAPE MONITOR B850 GE HEALTHCARE FINLAND OY JOEL KENT
K131576 08/30/2013 OPTIMA CT660 GE MEDICAL SYSTEMS, LLC HELEN PENG
K132200 08/14/2013 PRO HMPV+ ASSAY GEN-PROBE PRODESSE, INC EMILY ZIEGLER
K132159 08/14/2013 PROADENO+ ASSAY GEN-PROBE PRODESSE, INC EMILY ZIEGLER
K132237 08/26/2013 PRODESSE PROFAST+ ASSAY GEN-PROBE PRODESSE, INC. EMILY ZIEGLER
K132129 08/09/2013 PRODESSE PROFLU+ ASSAY GEN-PROBE PRODESSE, INC. EMILY ZIEGLER
K132238 08/26/2013 PROPARAFLU+ ASSAY GEN-PROBE PRODESSE, INC. EMILY ZIEGLER
K130374 08/29/2013 OMNI-VUE 2 SYSTEM GENESIS DIGITAL IMAGING, INC. CARL ALLETTO
K130516 08/23/2013 CARDIODAY GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG BERT SCHADOW
K123864 08/12/2013 GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM GIVEN IMAGING LTD. TIM THOMAS
K130392 08/15/2013 KINEX BIOACTIVE GLOBUS MEDICAL INC. SARAH MARIE FITZGERALD
K130682 08/13/2013 MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT HAGER & MEISINGER GMBH WIEBKE STOLTEN
K123076 08/09/2013 PROFTHAND MECHANICAL WHEELCHAIR HARMONY HILL INTERNATIONAL TINA LAI
K130685 08/09/2013 HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY HITACHI CHEMICAL DIAGNOSTICS, INC. ERIKA AMMIRATI
K131581 08/22/2013 MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK) HOLOGIC, INC. SARAH FAIRFIELD
K131736 08/22/2013 MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK) HOLOGIC, INC. SARAH FAIRFIELD
K131870 08/14/2013 GLIDE DEVICE HOME SKINOVATIONS LTD. AHAVA STEIN
K123604 08/16/2013 ABG III MONOLITHIC HIP STEM HOWMEDICA OSTEONICS CORP COLLEEN BURDEL
K131419 08/09/2013 ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM I-SENS, INC. CHAE YUN LIM
K130696 08/21/2013 CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM I-SENS, INC. CHAE YUN LIM
K131722 08/07/2013 I.T.S. EXTREMITY FIXATION SYSTEMS I.T.S. GMBH AL LIPPINCOTT
K131279 08/09/2013 ICONACY I-HIP SYSTEM ICONACY ORTHOPEDIC IMPLANTS, LLC MARC E RUHLING
K123724 08/28/2013 DERMISEB CREAM IGI LABORATORIES, INC. FREDERICK WEISS
K131097 08/22/2013 LEGACY3 6MM LENGTH IMPLANTS IMPLANT DIRECT SYBRON MANUFACTURING LLC INES ARAVENA
K130846 08/08/2013 MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN INDUSTRIAL CLOTHINGS, LTD. S.N. HARI
K131277 08/28/2013 SEVIIN FRACTURE SHOULDER INGEN ORTHOPEDICS LLC PERRY A GEREMAKIS
K130635 08/26/2013 SEVIIN SURFACE REPLACEMENT SHOULDER INGEN ORTHOPEDICS LLC PERRY A GEREMAKIS
K123987 08/27/2013 IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET INNOVATIVE MEDICAL TECHNOLOGIES, INC. BRAD BROWN
K131294 08/29/2013 OMNIPOD INSULIN MANAGEMENT SYSTEM INSULET CORPORATION TARA N TURNEY
K131184 08/30/2013 INTEGRA LICOX PTO2 MONITOR INTEGRA LIFESCIENCES CORP. ELIZABETH MCMENIMAN
K130821 08/09/2013 INTEL-GE CARE INNOVATIONS CONNECT RCM INTEL-GE CARE INNOVATIONS LLC MAUREEN GLYNN
K131584 08/21/2013 IMDX FLU A/B AND RSV FOR ABBOTT M2000 INTELLIGENT MEDICAL DEVICES, INC FRAN WHITE
K130140 08/01/2013 INTRA-LOCK OP DENTAL IMPLANT INTRA-LOCK INTERNATIONAL DIANA TAYLOR
K130266 08/29/2013 ENDOWRIST ONE VESSEL SEALER INTUITIVE SURGICAL, INC. CRYSTAL ONG
K132359 08/30/2013 MRI PATIENT MONITORING SYSTEM INVIVO CORPORATION RUSTY KELLY
K130436 08/20/2013 MULTILINK HYBRID ABUTMENT CEMENT IVOCLAR VIVADENT AG DONNA MARIE HARTNETT
K124014 08/09/2013 SUREFIX INTERSPINOUS FUSION SYSTEM JG SPINE, LLC JOHN KAPITAN
K130931 08/30/2013 EASY DAY (METHAFILCON A) 1-DAY SOFT (HYDROPHILIC) CONTACT LENS JIANGSU HORIEN CONTACT LENS CO., LTD. JENNIFER REICH
K131124 08/28/2013 COLIGN JILIN CORONADO MEDICAL LTD. ERIC CHIEN
K131784 08/30/2013 RANGE SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K131254 08/20/2013 KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE KIMBERLY-CLARK CORP. MARCIA JOHNSON
K113806 08/20/2013 KIMGUARD ONE STEP STERILIZATION WRAP KIMBERLY-CLARK HEALTH CARE CHRISTOPHER B SWANSON
K130936 08/22/2013 AERODR SYSTEM WITH P-31 KONICA MINOLTA MEDICAL & GRAPHIC, INC. RUSSEL MUNVES
K131430 08/30/2013 CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL KURARAY NORITAKE DENTAL INC. MICHIO TAKIGAWA
K131432 08/22/2013 CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND; CLEARFIL KURARAY NORITAKE DENTAL INC. MICHIO TAKIGAWA
K131068 08/27/2013 TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID KURARAY NORITAKE DENTAL INC. MICHIO TAKIGAWA
K123999 08/28/2013 ILLUMASK ACNE LIGHT THERAPY MASK LA LUMIERE, LLC ROBERT SEIPLE, RAC
K130798 08/23/2013 PRE-FORMED GUIDEWIRES LAKE REGION MEDICAL, INC. MATHEW PEXA
K132190 08/05/2013 EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME LEMAITRE VASCULAR, INC. ANNA KASSERIS
K123473 08/13/2013 HOPER PTCA BALLOON CATHETER LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD ARTHUR GODDARD
K132204 08/22/2013 INSUFLOW SYNERGY XL PORT LEXION MEDICAL, LLC. BERNARD HORWATH
K131048 08/28/2013 LIDCO CNAP MODULE LIDCO LTD. GREGORY SPELLER
K123563 08/20/2013 LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM MAGELLAN DIAGNOSTICS STUART NAYLOR
K131158 08/21/2013 CORVIEW MARREK, INC JEREMY M FOTHERINGHAM
K130345 08/01/2013 AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING MAYER LABORATORIES, INC. DAVID P MAYER
K131310 08/22/2013 GMK FULL PE TIBIAL COMPONENTS MEDACTA INTERNATIONAL ADAM GROSS
K130299 08/15/2013 GMK HINGE MEDACTA INTERNATIONAL ADAM GROSS
K130687 08/15/2013 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER MEDICAL COMPONENTS INC JESSICA LEO
K131687 08/16/2013 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET MEDICAL COMPONENTS INC JESSICA LEO
K130179 08/08/2013 MP VIAL ADAPTER 13MM MEDIMOP MEDICAL PROJECTS, LTD. ILANIT GOLDGRABER
K131155 08/28/2013 UGFT3; FHT7 MEDISIM LTD. MOSHE YARDEN
K122885 08/29/2013 MEDISIZE GOLD HEATER AND BOOSTER T-PIECE MEDISIZE BV IFFAT NOOR
K132332 08/22/2013 MOUNTAINEER OCT SPINAL SYSTEM MEDOS INTERNATIONAL SARL KIRSTEN LEHMULLER
K131517 08/02/2013 MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING MEDRAD, INC. / BAYER MEDICAL CARE, INC. LISA A EWING
K131425 08/14/2013 NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER MEDTRONIC NAVIGATION, INC. REGINA HOLMES
K130608 08/07/2013 QUADCUT MEDTRONIC NAVIGATION, INC. SHARON MCDERMOTT
K132111 08/06/2013 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA LAUREN KAMER
K131878 08/23/2013 LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM MEDYSSEY USA, INC. RICH JANSEN
K123988 08/15/2013 ANYONETM INTERNAL IMPLANT SYSTEM MEGAGEN IMPLANT CO., LTD APRIL LEE
K123792 08/30/2013 HORIZON XVU (FFR) MENNEN MEDICAL LTD. IFAT SHWARTS
K132226 08/09/2013 METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT MERETE MEDICAL GMBH EMMANUEL ANAPLIOTIS
K132409 08/29/2013 CONCIERGE GUIDING CATHETER MERIT MEDICAL SYSTEMS, INC. VICKI GODWIN
K130076 08/22/2013 PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS MERZ DENTAL GMBH
K131085 08/22/2013 CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000 MESPERE LIFESCIENCES INC. HELEN TAN
K124010 08/23/2013 ACCUSONIC ADVANTAGE METRON MEDICAL AUSTRALIA PTY LTD DAVID MITCHELL
K131247 08/14/2013 MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM MFS - MEDICAL FLOW SYSTEMS LTD OFER SHAY
K122766 08/20/2013 THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY MICROGENICS CORP. KAREN LEE
K123605 08/16/2013 SMARTFLOW CATHETER MRI INTERVENTIONS, INC. EDWARD F WADDELL
K123904 08/07/2013 PROTHELIAL MUELLER MEDICAL INTERNATIONAL LLC RICKY W MCCULLOUGH MD
K131391 08/21/2013 JUSHA-M32 MEDICAL DISPLAY NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD MIKE GU
K131345 08/07/2013 TIARRAY DENTAL IMPLANT SYSTEM NASSEO, INC. ALLISON C KOMIYAMA
K131694 08/08/2013 NMI PORT II CATHETER NAVILYST MEDICAL, INC. BRANDON M BRACKETT
K132587 08/29/2013 MD242C2 24" DIAGNOSTIC IMAGING LCD MONITOR NED DISPLAY SOLUTIONS LTD. TONY HSU
K131471 08/28/2013 SELF-COMPRESSIVE SCREW NEOSTEO JD WEBB
K131374 08/23/2013 TEMPUS(TM) CERVICAL PLATE SYSTEM NEUROSTRUCTURES, LLC MEREDITH MAY
K131415 08/09/2013 LIVE VIEW PANEL (LVP) NEUROTRONICS, INC. DAVID PEZET
K123797 08/27/2013 NT1D VITAL SIGNS MONITOR NEW TECH, INC. DIANA HONG
K131082 08/26/2013 INTERFORM INTERBODY CAGE SYSTEM NEXT ORTHOSURGICAL J.D. WEBB
K131061 08/28/2013 RESTORE BUNION CORRECTION SYSTEM NEXTREMITY SOLUTIONS JANET WEBB
K132072 08/15/2013 TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM NIPRO DIAGNOSTICS, INC. BETH FOSTER
K131641 08/28/2013 MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP) NIPRO MEDICAL CORPORATION JESSICA OSWALD-MCLEOD
K123347 08/02/2013 NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0 NORMED MEDIZIN-TECHNIK GMBH DAVID C FURR
K123766 08/15/2013 NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN NOVO NORDISK INC. LOIS KOTKOSKIE, PH. D
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