BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SKIN BARRIER FILM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MED GRAVITY SET, IMED PUMP SET

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

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·June 1, 2022

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 22, 2025

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 21, 2014

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 25, 2013

    MITEK VERSALOK TI ANCHOR

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code HWC·August 5, 2011