BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    SKILCRAFT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    iSLEEVE Introducer Set

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DILUTOR TRANSPORTER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·May 2, 2023

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·May 2, 2023

    INTERNAL PADDLES OPTION FOR DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 29, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 25, 2010

    OT ULTRASMART METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 20, 2012

    Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025