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

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    NICOLET VIKING

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    VITROS

    FDA UDI
    ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750030156·VITROS Chemistry Products HCY 2 Reagent

    NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VISION

    FDA 510(k)
    FDA Class 2 ·Radiology

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 13, 2014

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·November 21, 2012

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·September 23, 2010

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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