BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE

    FDA 510(k)
    FDA Class 2 ·Hematology

    NA

    FDA UDI
    STERILMED, INC.·10888551009331·BUR

    ESCOTEK-EST 301A ULTRA-SONIC UNIT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    YD STRIP GP U20

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GEMSTAR 7 SP REFURB

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 22, 2014

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·October 12, 2010

    PULSE GEN MODEL 102

    FDA Adverse Event
    Death ·CYBERONICS, INC.·Product code LYJ·December 14, 2012

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024