BEUDAMED
    12 results · 24ms · Sources: EU EUDAMED, US FDA

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    BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS

    FDA 510(k)
    FDA Class 2 ·Immunology

    URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TETHER ACFS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    C & B FORMULA

    FDA UDI
    AMERICAN TOOTH INDUSTRIES·D772ATI400404660·C & B FORMULA 4 OZ SHADE 66

    NAMILON POWDER

    FDA UDI
    AMERICAN TOOTH INDUSTRIES·D772ATI200404660·NAMILON POWDER 4 OZ SHADE 66

    PYROPLAST POWDER

    FDA UDI
    AMERICAN TOOTH INDUSTRIES·D772ATI100404660·PYROPLAST POWDER 4 OZ SHADE 66

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·March 13, 2013

    PFC SIGMA STAB INS SZ3 8MM

    FDA Adverse Event
    Injury ·DEPUY - RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC·Product code JWH·May 8, 2008

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·April 5, 2011

    SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

    FDA Enforcement
    Class II ·Terminated·Unomedical As·July 1, 2015

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018