BEUDAMED
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    DOBBHOFF ENTERIC FEEDING BAG

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

    URESTA PESSARY

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    2 JET SET

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    BRYAN CERVICAL DISC SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code MJO·April 30, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 10, 2012

    HEARTSTART FRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 19, 2015

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)

    FDA Enforcement
    Class II ·Terminated·Philips North America Llc·November 17, 2021