BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    ROTAVIRUS LATEX AGGLUTINATION ASSAY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PAJUNK MULTISTIM SENSOR NERVE STIMULATORS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TRIS BUFFERED SALINE

    FDA 510(k)
    FDA Class 2 ·Hematology

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 10, 2014

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·October 4, 2010

    MA204

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·November 2, 2012

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026