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

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    IMMUNOGL. FRCT. OF RABBIT ANTISER.-C4

    FDA 510(k)
    FDA Class 2 ·Immunology

    ORION DIGITAL IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    QUIDEL MOLECULAR HMPV ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    REALSEAL

    FDA Adverse Event
    Injury ·SYBRONENDO·Product code KIF·May 15, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012

    ENDOSCOPIC TRANSBRONCHIAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code FCG·August 17, 2010

    PHENOM CATHETER

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code QJP·February 27, 2026

    Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00, 979105, 14-441045-00, and 14-444000S

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 4, 2018