BEUDAMED
    12 results · 29ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO MAMMAPRINT

    FDA 510(k)
    FDA Class 2 ·Immunology

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B5820802520·AWL

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221024831·Unitek(TM) Lingual Sheaths Slotted Tube UR/LL D...

    MAGNUM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    INSIGHT 4000 ENDOSCOPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RD SET GE - 12

    FDA Adverse Event
    Malfunction ·Product code DQA·August 13, 2021

    LANX SPINOUS PROCESS FUSION PLATE

    FDA Adverse Event
    Injury ·LANX, INC.·Product code KWP·March 17, 2011

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013

    EON RECHARGEABLE IPG

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·April 7, 2011

    SYNCHROMED EL

    FDA Adverse Event
    Malfunction ·RICE CREEK MANUFACTURING·Product code LKK·July 22, 2008

    HANDLE CEV102910R DIA 10MM ANG W/RATCHET [MXI/XOM]

    FDA Adverse Event
    Injury ·XOMED MICROFRANCE MFG·Product code GCJ·December 20, 2013

    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