BEUDAMED
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    3Shape Scan Bodies

    FDA UDI
    3shape Trios A/S·05902729751612·XiVE - Regular platform - Connection: 3,4

    RADKOR DXG-650R

    FDA 510(k)
    FDA Class 1 ·Radiology

    AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    Dandy Scan Body

    FDA UDI
    Coremedtech ApS·05744003810277·Dandy Scan body, by CoreMedTech, for dental Int...

    Agfa Computed Radiography Systems with DX-G Digitizer. DX-G Digitizers haved the same intended use as the predicate devices. they are intended to use in providing diagnostic images to aid the physician with diagnosis. DX-G Digitizers provide the ability to use both standand needle phosphor image plates and can be used with either Musica or Musica 2. In the US, Agfa's Computed Radiography Systems with DX-G Digitizers are not intended for use in mammography.

    FDA Recall
    Terminated ·AGFA Corp.·Product code MQB·December 6, 2011

    DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium.

    FDA Recall
    Terminated ·AGFA Corp.·Product code MQB·October 8, 2010

    EV1000

    FDA Adverse Event
    Malfunction ·EDWARDS LIFE SCIENCES·Product code DSB·June 24, 2025

    FLOTRAC, VAMP

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXG·October 19, 2023

    FLOTRAC, VAMP

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXG·October 19, 2023

    FLOTRAC, VAMP

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXG·October 19, 2023

    PEDIASAT

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code DRE·December 10, 2025

    EV1000

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES IRVINE·Product code DSB·June 3, 2025

    EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code DQE·October 28, 2025

    EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code DQE·December 23, 2025

    FLOTRAC

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXG·October 23, 2023

    FLOTRAC

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, DR·Product code DQE·December 20, 2023

    EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DQE·October 19, 2023

    EV1000

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES IRVINE·Product code DSB·January 28, 2026

    VIGILANCE II CCO-SV02/CEDV MONITOR

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXG·November 10, 2016

    APCO9 CABLE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXG·November 14, 2016