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

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    CK-1 ULTRAZYME PLUS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EVOLUTION Revision CCK System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LENS SET, MENTOR TRIAL

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    M2A-MAGNUM PF CUP 54ODX48ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·April 24, 2014

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·September 27, 2012

    FINELINE II

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVN·July 27, 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

    GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·June 25, 2014