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

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    AMYLASE ULTRAZYME PLUS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EndoWrist Stapler 45 System and Stapler 45 Reloads

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

    GENTIAN CYSTATIN C IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    WECH HEM-O-LOK XL ENDO 10, APPLIER

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

    M2A-MAGNUM MOD HD SZ 48MM

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

    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