BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    ISOLIGHT

    FDA 510(k)
    FDA Class 1 ·Dental

    FUKUDA DENSHI EH-11

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RIONET HEARING AID HB-34AS

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 25, 2014

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Death ·CORDIS LLC (PR)·Product code NIQ·January 3, 2013

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·November 4, 2010

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020