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

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    VOLUME VENTILATOR

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    KENDALL CO2NFIRM NOW CO2 DETECTOR

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

    Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    PULSE GEN MODEL 102

    FDA Adverse Event
    Death ·CYBERONICS, INC.·Product code LYJ·February 4, 2013

    ULTRAPRO MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·December 23, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·July 17, 2014

    T5-NT, Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·April 25, 2018

    T5 Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·April 25, 2018