6 results
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19ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code FDT·July 21, 2017
Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code FET·June 30, 2015
Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment.
FDA Enforcement
Class II
·Terminated·Fujinon Inc·November 6, 2013
Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastrointestinal electronic video endoscopes.
FDA Recall
Terminated
·Fujinon Inc·Product code FDF·March 27, 2006
Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment.
FDA Recall
Terminated
·Fujinon Inc·Product code FDS·July 31, 2013
Fujinon Endoscope Series; Model # EPX-4400 and EPX-4400HD. Digital processing of images from endoscope.
FDA Recall
Terminated
·Fujinon Inc·January 7, 2011