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

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    HICHEM ISE DILUENT KIT 70008

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ITE HEARING AID, SAAPHIRE MODEL

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

    REPAIR KIT QUINTON TRIPLE LUMEN RIGHT ATRIAL CATHE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·January 11, 2013

    ECHELON 60

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·January 10, 2011

    ENDURANT

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·July 23, 2014

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020