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

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    SIMPLASTIN EXCEL

    FDA 510(k)
    FDA Class 2 ·Hematology

    SGPT REAGENT SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DENTSPLY G-106 CAVITRON ULTRASONIC

    FDA 510(k)
    FDA Class 2 ·Dental

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 10, 2014

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·October 7, 2010

    LIFEPAK CR® PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·December 10, 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