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

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    CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STONE, INSTRUMENT HONING

    FDA 510(k)

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 18, 2014

    SURE-VUE SERUM/URINE HCG-STAT

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

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·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