BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    TRAY, FOLEY CATHETER

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

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110669·COAXIAL IRR-ASP- TIP 90 DEG- W/ SILICONE

    GORE DrySeal Flex Introducer Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO INFINITY EXPLORER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GORE DRYSEAL FLEX INTRODUCER SHEATH

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DYB·October 19, 2020

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code DYB·October 6, 2016

    BATTERY OSCILLATOR

    FDA Adverse Event
    Malfunction ·NI·Product code GEY·April 19, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 26, 2012

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 16, 2010

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DYB·May 30, 2023

    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