BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    MICROZYME TSH ENZYME IMMUNOASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517824752·CoRoent XL Sizer, 11x18x55mm 10°

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756373289·HEART PACK

    IMAGEN Parainfluenza Virus Types 1, 2 and 3

    FDA UDI
    OXOID LIMITED·05032384502974·

    PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ATAMA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·January 11, 2013

    ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT)

    FDA Adverse Event
    Injury ·GUIDANT ENDOVASCULAR SOLUTIONS·Product code MIH·November 18, 2010

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 2, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021