BEUDAMED
    213 results · 31ms · Sources: EU EUDAMED, US FDA

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    SIGNA ADVANTAGE MAGNETIC RESONANCE SYSTEM M1090GF

    FDA 510(k)
    FDA Class 2 ·Radiology

    3) Signa Advantage (K911959 Signa Advantage 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

    AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE

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

    QuantX Breast MRI Biopsy Guidance Plugin

    FDA 510(k)
    FDA Class 2 ·Radiology

    HISTOACRYL BLUE 0.5ML

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·November 22, 2019

    HISTOACRYL BLUE 0.5ML

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·December 6, 2019

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    FDA Adverse Event
    Malfunction ·REYNOSA MANUFACTURING·Product code FKX·May 13, 2014

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code MMI·December 1, 2010

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·January 11, 2013

    HISTOACRYL BLUE 0.5ML

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·June 27, 2019

    HISTOACRYL BLUE 0.5ML

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·October 17, 2019

    HISTOACRYL BLUE 0.5ML

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·April 18, 2019

    HISTOACRYL BLUE 0.5ML

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·April 18, 2019

    HISTOACRYL BLUE 0.5ML

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·April 18, 2019

    HISTOACRYL BLUE TISSUE ADHESIVE

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL SA·Product code MPN·January 23, 2020

    HISTOACRYL BLUE 0.5ML

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·September 23, 2019

    HISTOACRYL BLUE 0.5ML

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·March 8, 2019

    HISTOACRYL BLUE 0.5ML

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·August 6, 2019

    HISTOACRYL BLUE 0.5ML

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·September 3, 2019

    HISTOACRYL BLUE 0.5ML

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL SA·Product code MPN·December 10, 2018