BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    AZIDE FREE BLOOD DILUTING REAGENT

    FDA 510(k)
    FDA Class 1 ·Hematology

    RELAXATION COURSE MODEL 1000

    FDA 510(k)
    FDA Class 2 ·Neurology

    BEMITT, MODEL 0001

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code LTJ·April 24, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 2, 2012

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·July 28, 2010

    ACCOLADE SR SL MRI (Model L310)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025