inforMED
NZPClass II

Sealant, Microbial

General, Plastic Surgery · 21 CFR 878.4370

Intended to isolate the site of a surgical incision from microbial contamination and indicated to reduce the risk of skin flora contamination of the surgical incision throughout a surgical procedure.

MDR events12All time
Recalls0All time
Registered firms10Currently listed
510(k) clearances4All time

Recent MDR events

12 adverse event reports on file

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Event type breakdown

Malfunction10
Injury2

Most-reported manufacturers

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Avanos Medical, Inc.3Halyard Health3Adhezion Biomedical /h.b. Fuller Medical Adhesive Technologies, Llc1Avanos Medical Inc.1H.b. Fuller Medical Adhesive Technologies, Llc1Halyard (lab) Irvine1Halyard (lab), Formerly Known As Kimberly Clark1Kimberly-clark Health Care1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

10 firms currently registered for this product code

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510(k) clearances

4 clearances for this product code

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