BEUDAMED
    8 results · 33ms · Sources: EU EUDAMED, US FDA

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    CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3

    FDA 510(k)
    FDA Class 2 ·Hematology

    OMKNEE SYSTEM, POROUS COATED

    FDA 510(k)

    WEILL CEMENTLESS THREADED ACETABULAR CUP

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 8.5 F

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL·Product code DYB·January 22, 2024

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 25, 2014

    PULSE GEN MODEL UNK

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·November 5, 2010

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 20, 2012

    Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025