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

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    ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    KETAC-CEM IN REF. TO K802048

    FDA 510(k)
    FDA Class 2 ·Dental

    E. COLI PNA FISH

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ORG-9200A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PLUM A+ DRIVER ED 2

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·February 4, 2014

    ATTAIN STARFIX

    FDA Adverse Event
    Death ·MPRI·Product code OJX·October 23, 2012

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·August 16, 2010

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022