BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    TDX (R) DIGOXIN NXT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331136269·hohmann retractor, 15.0 mm wide, 6" (15.0 cm)

    VIKY

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

    FlowTriever Retrieval/Aspiration System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 18, 2014

    CAPSURE SP

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 26, 2010

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 20, 2012

    OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·June 26, 2024

    SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024