BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    EMG/NCV & EVOKED RESPONSE, DESIGN W/

    FDA 510(k)
    FDA Class 2 ·Neurology

    O-MAR

    FDA 510(k)
    FDA Class 2 ·Radiology

    VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RETROFLEX 3 INTRODUCER SHEATH SET

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYB·June 2, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·November 21, 2012

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·September 24, 2010

    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