inforMED
FSRClass II

Light, Headband, Surgical

Ophthalmic · 21 CFR 886.4335

MDR events100All time
Recalls0All time
Registered firms21Currently listed
510(k) clearances4All time

Recent MDR events

100 adverse event reports on file

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Event type breakdown

Malfunction87
Injury11
Unspecified2

Most-reported manufacturers

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Integra Lifesciences (ireland) Ltd.48Unspecified14Integra York, Pa Inc.14Integra Burlington, Ma, Inc.7Integra Lifesciences(ireland)4Baxter Healthcare Corporation1Integra Burlington Ma, Inc.1Integra Burlington, Ma, Inc1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

21 firms currently registered for this product code

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510(k) clearances

4 clearances for this product code

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