BEUDAMED
    10 results · 18ms · Sources: EU EUDAMED, US FDA

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    C-ARM X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    NA

    FDA UDI
    KEY SURGICAL, INC.·00849771052296·K-Wire and Steinmann Pin Dispensers, No Dispen...

    HORIZON Therapy System

    FDA 510(k)
    FDA Class 2 ·Neurology

    FRAXEL III SR LASER SYSTEM AND ACCESSORIES

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

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code NIU·November 16, 2017

    ARCHITECT I2000SR ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·October 3, 2012

    ALLEGRETTO WAVE EYE-Q

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code LZS·December 18, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2015

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code NIU·September 11, 2013

    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