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

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    NORSEN DEBRIDER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    QUINTEX CERVICAL PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GALILEO NEO

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·May 20, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 6, 2012

    CCU BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·August 26, 2010

    Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

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