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

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    CHILDREN'S SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    CORONIS COLOR 3MP AND MDCC 3120-DL

    FDA 510(k)
    FDA Class 2 ·Radiology

    SILENTSLEEP

    FDA 510(k)
    FDA Class 1 ·Dental

    CAPSURE SENSE

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

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·October 8, 2010

    MA204

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·October 31, 2012

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

    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