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

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    ALLOY DISPOS-A-CAP DENTAL SCHOOL CAP

    FDA 510(k)
    FDA Class 2 ·Dental

    CARDINAL HEALTH

    FDA Adverse Event
    Malfunction ·CAREFUSION 207, INC.·Product code CAI·November 19, 2009

    SEQUENTIAL PRESSURE CUFF

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STOPCOCK, ONE WAY

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

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·May 22, 2019

    VALIANT CAPTIVIA

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·April 24, 2014

    OEM UNKNOWN

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code GAM·September 26, 2012

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·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