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

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    QUAN. COLOR. DETER. OF SERUM ALBUMIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    Ambu

    FDA UDI
    Bosma Enterprises·10818634025163·Ambu aScope 4 Broncho Regular 5.0/2.2 5/Box

    INSTRUMED RETRACTORS

    FDA 510(k)
    FDA Class 2 ·Neurology

    ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 24, 2014

    SLIMLINE 200

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code GEX·September 30, 2012

    ESSURE

    FDA Adverse Event
    Injury ·BAYER·Product code HHS·May 14, 2015

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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