BEUDAMED
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    FLEXIFLO QUANTUM ENTERAL PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BALLOON CATHETERS

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

    FERNO-WASHINGTON BASKET STRETCHER, MODEL 71-W

    FDA 510(k)
    FDA Class 1 ·General Hospital

    COULTER® AC*T SERIES ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·February 5, 2013

    DEXTRUS

    FDA Adverse Event
    Injury ·EXTERNAL MANUFACTURER·Product code NVN·January 3, 2011

    ESSURE

    FDA Adverse Event
    Injury ·ESSURE·Product code HHS·July 14, 2014

    Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026