BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    brAIn™ Shoulder Positioning

    FDA 510(k)
    FDA Class 2 ·Radiology

    TheraCal DC

    FDA 510(k)
    FDA Class 2 ·Dental

    HEMOCATH

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

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 11, 2014

    ASR ACETABULAR IMPLANT 56

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 12, 2011

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 23, 2013

    Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area.

    FDA Enforcement
    Class II ·Terminated·Atrium Medical Corporation·February 22, 2017