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

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    MIGHTY MAN (DYNAMIC LINKERS)

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

    HEMOSIL F11 & FV DNA CONTROL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MQF·November 30, 2018

    TROJAN PLEASURE PACK LUBRICATED CONDOMS

    FDA Adverse Event
    Injury ·CHURCH & DWIGHT CO., INC.·Product code HIS·October 29, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 7, 2013

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·January 26, 2011

    CAPSURE SP NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·August 8, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021