BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    Hailie Sensor

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    POLYMOBIL PLUS

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHINEERS AG·Product code IZL·February 24, 2026

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·July 28, 2011

    6000CMS IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·June 11, 2013

    MOBILETT ELARA MAX

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE GMBH·Product code IZL·December 18, 2020

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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