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

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    SWIVEL HEAD ADJUSTABLE CRUTCH

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Galaxy UNYCO System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OT ULTRALINK METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·October 3, 2012

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 24, 2014

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·July 19, 2010

    NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·August 14, 2024

    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

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025