BEUDAMED
    15 results · 20ms · Sources: EU EUDAMED, US FDA

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    DUPONT DIMENSION AMYLASE METHOD

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Xcaliber Bone Screws

    FDA UDI
    ORTHOFIX SRL·18054242511007·SELF DRILLING XCALIBER CYLINDRICAL SCREW SHAFT ...

    Xcaliber Bone Screws

    FDA UDI
    ORTHOFIX SRL·18054242511991·SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D...

    LARGE AO COUPLING ASNIS III HALL FITTING

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·September 25, 2012

    Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNI-THREAD SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNKNOWN SHELL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·August 8, 2018

    28MM DIA COCR MOD HD -6MM NK

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·August 6, 2018

    UNKNOWN TAPERLOC STEM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·August 7, 2018

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·December 30, 2010

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD.·Product code MCM·February 4, 2013

    COULTER ACT DIFF ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·July 17, 2014

    ARCOS 17X190MM SPL TPR DIST

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·August 7, 2018

    ARCOS CON SZ C STD 70MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·August 6, 2018

    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