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

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    GUTTA GUN

    FDA 510(k)
    FDA Class 1 ·Dental

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489125563·PowerChem Neoprene Exam Gloves, Extra Extra Large

    AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER

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

    Optum TeleHealth Application

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·March 11, 2024

    AUTOPULSE® LI-ION BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC·Product code DRM·April 24, 2014

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 27, 2012

    FINELINE II

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVN·July 27, 2010

    K-FILE M-ACCESS 25MM 030

    FDA Adverse Event
    Malfunction ·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EKS·December 8, 2025

    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