BEUDAMED
    7 results · 29ms · Sources: EU EUDAMED, US FDA

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    QuickVue COVID-19 Test

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RELIANT LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS

    FDA 510(k)
    FDA Class 2 ·Radiology

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 1, 2011

    TRUERESULT

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·July 15, 2013

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022