BEUDAMED
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    ANTI-HUMAN LAMBDA SERUM

    FDA 510(k)
    FDA Class 2 ·Immunology

    Infrared Thermometer, Breeze model

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CAPILLARYS NEONAT HB (PN 2006)

    FDA 510(k)
    FDA Class 2 ·Hematology

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 5, 2014

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code LWS·October 15, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·May 22, 2015

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025