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FUJIFILM

FUJIFILM CORPORATION · Model EN-450T5 · UDI-DI 04547410330960

FDA Prescription

510(k) clearances

796

Adverse events (10 deaths)

Recalls

Facilities

Description

This device is intended for the visualization of the upper and lower digestive tracts, specially for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine, large intestine and rectum.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.