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

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    POLY/PLATINUM WIRE PISTON

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    JAIN SUTURE/VESIBAND ORGANIZER

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

    FOXELL PLUS MULTIPLE(PERSONAL TOUCH), MODIFICATION

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PINNACLE SECTOR II CUP 56MM

    FDA Adverse Event
    Injury ·DEPUY SYNTHES·Product code KWA·February 6, 2013

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·January 3, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·July 18, 2014

    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