BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    CRITIKON 48-HOUR AIR ELIMINATING FILTER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VACUUM WAND AND UNI-READER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    HEKTOEN ENTERIC AGAR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SENSIA SR

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NVZ·June 10, 2014

    SIGMA 300 DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·October 8, 2010

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·November 29, 2012

    SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024

    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