inforMED
MNKClass I

Endoscopic Bite Block

Gastroenterology, Urology · 21 CFR 876.1500

To prevent patient from biting down in order to protect fragile endoscope equipment, patient's teeth and gums, and endscopist's fingers when inserting endoscope orally.

MDR events161All time
Recalls0All time
Registered firms126Currently listed
510(k) clearances6All time

Recent MDR events

161 adverse event reports on file

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Event type breakdown

Malfunction132
Injury25
Unspecified4

Most-reported manufacturers

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Aizu Olympus Co., Ltd.46Teleflex Medical29Jiangsu Jianyu Health Medical Co Ltd28Boston Scientific Corporation16Keymed (medical And Industrial Equipment) Ltd.8United States Endoscopy Group, Inc.8Olympus Medical Systems Corp.5Teleflex Incorporated3

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

126 firms currently registered for this product code

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510(k) clearances

6 clearances for this product code

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