BEUDAMED
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    Spectralis HRA+OCT and Variants

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM

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

    MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PFC SIGMARP STB TB IN 3 20.0

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code NJL·October 24, 2023

    ONE TOUCH ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·October 6, 2008

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 27, 2013

    837- KIN AIR MED SURGE PULSE

    FDA Adverse Event
    Malfunction ·KCI·Product code INX·August 1, 2011

    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems·October 10, 2018