BEUDAMED
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    Filters Regulation: Us FDA ×

    CRYOcheck Factor VIII Deficient Plasma with VWF

    FDA 510(k)
    FDA Class 2 ·Hematology

    VIDEO SYSTEM CENTER

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

    MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code PJE·June 4, 2025

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code PJE·June 3, 2025

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code PJE·June 3, 2025

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·November 6, 2008

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 25, 2011

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code IOR·July 12, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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