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

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    Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)

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

    COMPUTED RADDIOGRAPHY SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    THE FINGER GUARD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    APOLLO GENERATOR

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code GWG·June 11, 2015

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·May 23, 2016

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·May 23, 2016

    I-STAT 6+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2017

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code ITJ·October 8, 2014

    CAPSURE Z NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 7, 2013

    8800

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD.·Product code JAA·June 22, 2011

    7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior related to swallowing in the pharyngeal area for medical and pedagogical applications.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·July 26, 2017

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023