BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    AUTORANGE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Swiss LithoClast Trilogy

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

    PERFADEX WITH THAM

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

    RESTORE SENSOR SURESCAN MRI

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·April 30, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 29, 2007

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCO·Product code CBK·October 5, 2012

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021