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

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    LASERSONICS LASER CYSTOSCOPE MODEL FCY-6-35

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

    S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VANTAGE INDIRECT OPHTHALMOSCOPE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 14, 2014

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 7, 2010

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 6, 2012

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014