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

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    IC MICROASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    ME-TOO OXYGEN CONCENTRATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ASSERACHROM IX:AG

    FDA 510(k)
    FDA Class 2 ·Hematology

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 10, 2014

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 7, 2010

    PINNACLE

    FDA Adverse Event
    Malfunction ·TOLLOS (FORMERLY T.H.E. MEDICAL)·Product code FNG·November 28, 2012

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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