BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    MICROFLATOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704293883·

    CHEMISTRY, COULTER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ASR ACETABULAR CUPS 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·October 4, 2012

    VALIANT CAPTIVIA

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·May 14, 2015

    RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KNQ·July 27, 2010

    Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.

    FDA Enforcement
    Class II ·Terminated·Abbott Vascular·October 3, 2012

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024