BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    X-RAY TUBE - PANOBEAM

    FDA 510(k)
    FDA Class 2 ·Dental

    TEST, LACTATE DEHYDROGENASE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SOFTDISO

    FDA 510(k)
    FDA Class 2 ·Radiology

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·March 7, 2014

    MINIARC SINGLE-INCISION SLING

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·October 1, 2012

    DEXTRUS 4135

    FDA Adverse Event
    Other ·BIOTRONIK SE & CO. KG·Product code NVZ·July 19, 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