BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    InBody Blood pressure monitor, Model BPBIO480KV

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·November 3, 2014

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·August 17, 2011

    SILICONE ROUND DRAIN

    FDA Adverse Event
    Injury ·CR BARD INC·Product code GBX·July 5, 2013

    Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·February 14, 2024