BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    Aveli

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Mepilex® Up

    FDA UDI
    Mölnlycke Health Care AB·07333350795542·Mepilex Up, 15x15 cm US

    UNITE BIOMATRIX

    FDA 510(k)
    FDA Unclassified ·Unknown

    MODIFICATION TO ELECSYS FSH II CALSET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 15, 2011

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    UNKNOWN·Product code ITJ·October 30, 2014

    OUTBACK RE-ENTRY CATHETER

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code DQY·July 9, 2013

    TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The TriForce Peripheral Crossing Set is intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral interventions. This device is also intended for injection of radiopaque contrast media for the purpose of angiography.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023