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

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    BIO-GUARD AB COATED CATHETER

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

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704289367·

    LINDE INTEGRATED VALVE (LIV)

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    ULTRACHEM ENZYMATIC CHOLESTEROL OXIDASE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 10, 2014

    ASKU

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·October 9, 2010

    TALENT STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·December 10, 2012

    Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX

    FDA Enforcement
    Class I ·Ongoing·Baxter Healthcare Corporation·March 12, 2025

    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