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

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    SILICONE SUMP DRAIN 20 & 40 FRENCH

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MONDEAL

    FDA UDI
    MONDEAL Medical Systems GmbH·04050435063978·MCD Screw 4.0 x 24 mm cannulated M3 partia...

    Critical Cover

    FDA UDI
    Alpha Pro Tech, Inc.·10817583022230·Coverall, AlphaGuard, Blue, Inset Sleeve, Zip C...

    WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH

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

    RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE·Product code CAW·May 30, 2014

    SCREW

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·November 20, 2012

    V200 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC·Product code CBK·June 12, 2015

    CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is suitable for service in hospital, transport and homecare as a source of continuous or intermittent positive pressure ventilator support, delivered invasively or non-invasively. These ventilators are restricted medical devices intended for operation by a trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations.

    FDA Recall
    Terminated ·Product code CBK·August 8, 2014