BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD)

    FDA 510(k)
    FDA Class 2 ·Immunology

    TXP TRANSPORTER FAMILY AND RELATED ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EVOLUT R TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 3, 2020

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·May 22, 2014

    UNKNOWN ZIMMER HIP

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code JDI·November 2, 2010

    THERMODILUTION CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DYG·December 18, 2012

    TCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash cards: 914-698 (Defective Device Component)

    FDA Recall
    Terminated ·Radiometer America Inc·Product code KLK·April 7, 2006