BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    MASK, SURGICAL, FACE, DISPOSABLE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    REVERA WOUND CARE, MODEL MDW0060

    FDA 510(k)
    FDA Unclassified ·Unknown

    KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 12, 2007

    PENUMBRA SYSTEM REPERFUSION CATHETER 054

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code NRY·October 3, 2012

    INTELLIVUE MP2

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·March 5, 2014

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015