BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    NERVEL-NERVE CONDUCTION VELOCITY METER

    FDA 510(k)
    FDA Class 2 ·Neurology

    1.5T PEDIATRIC HEAD AND SPINE ARRAY MODEL

    FDA 510(k)
    FDA Class 2 ·Radiology

    Reveal LINQ

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GAMMA XL

    FDA Adverse Event
    Death ·DRAEGER MEDICAL SYSTEMS, INC.·Product code MHX·April 10, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·September 26, 2012

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·July 14, 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

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Model Number U228, VISIONIST CRT-P EL MRI

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