BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    FINDRWIRZ GUIDE WIRE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Regent

    FDA UDI
    SPINAL ELEMENTS·00840916114985·Regent ACP 3-Level, 64mm

    MCC-MIV ONE 2 ONE SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ACCU-CHEK COMPLETE METER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SEE H10 NARRATIVE

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·September 11, 2017

    UNKNOWN LINER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·February 10, 2015

    BARD ACCESS SYSTEM

    FDA Adverse Event
    Malfunction ·BARD ACCESS SYSTEMS·Product code LJS·April 22, 2013

    SWIFT-LOCK ANCHOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·April 22, 2011

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code NIQ·July 22, 2008

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014