BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    MT One

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

    Costco

    FDA UDI
    Bernafon AG·05711584089583·CAPTO 1 MNR T, 2.4G NFM DPB MAC COSTC

    LUCINA-MELODI

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SIROCCO THERMAL REGULATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    I-STAT E3+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·March 31, 2020

    SUR-FIT NATURA POUCH

    FDA Adverse Event
    Other ·CONVATEC·Product code EZQ·October 20, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 25, 2011

    INTERLOCK?-35

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - CORK·Product code KRD·June 27, 2013

    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