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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    API 20E/UNISCEPT 20E

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SwishPlus® Implant

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307106227·Ø3.7 x 8 Platform 3.5mmD

    TEC1410 ANATOMICAL PROGRAMMING GENERATOR-MODIFICAT

    FDA 510(k)
    FDA Class 1 ·Radiology

    GLYC-AFFIN GP

    FDA 510(k)
    FDA Class 2 ·Hematology

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·January 22, 2013

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 5, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·December 7, 2010

    SwishPlus Implant Intended for use in support for fixed bridgework.

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·March 28, 2018