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FUJIFILM
FUJIFILM CORPORATION · Model ES-450WE5 · UDI-DI 04547410330977
10
510(k) clearances
54
Adverse events
2
Recalls
25
Facilities
Description
This product is a medical Endoscope for the lower digestive tract. It is intended for observation, diagnosis, and endoscopic treatment of the rectum and large intestine at medical facilities under management of physicians.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-04-06 | Pentax Medical Company | Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the U |
| 2016-04-06 | Pentax Medical Company | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel. |
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Get your free API keyRead the docsData 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.