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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    HENRY SCHEIN SURGICAL MASK

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

    LARGE FACE ANEROID SPHYGMOMANOMETER, WALL MODEL, DESK MODEL, MOBILE STAND MODEL, MODEL 41XX, 42XX, 43XX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Servo-air 4.0 Ventilator System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 7, 2013

    GEM VR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·February 15, 2011

    ATTAIN ABILITY

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·August 8, 2014

    2) Signa Advantage SP (K942604 Signa Advantage SP MR System) A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·November 9, 2010