BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    COMPUTER ECG TERMINAL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704293777·

    NA

    FDA UDI
    KEY SURGICAL, INC.·10849771049910·Steinmann Pins, Single diamond, 3 shank end, 0....

    EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BM.IRIS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·April 24, 2014

    ALMA HARMONY

    FDA Adverse Event
    Injury ·ALMA HARMONY·Product code GEX·October 1, 2012

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·May 13, 2015

    dS Breast 7ch 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024