BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    ENDOSCOPIC TRAY

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    Real Time Image Gating System for Proton Beam Therapy Systems

    FDA 510(k)
    FDA Class 2 ·Radiology

    DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·October 3, 2012

    ALLEGRETTO WAVE EYE-Q

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code LZS·December 18, 2013

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD.·Product code MCM·July 27, 2010

    Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

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

    GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·June 25, 2014