BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    SPQ(TM) TEST SYSTEM FOR PREALBUMIN

    FDA 510(k)
    FDA Class 1 ·Immunology

    SUPPLEMENTAL FEEDING SYSTEM

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    PROPPER SERACULT

    FDA 510(k)
    FDA Class 2 ·Hematology

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 19, 2014

    BV PULSERA

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NORTH AMERICA·Product code IZL·October 25, 2010

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 22, 2012

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015

    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