BONDEASE TOPICAL SKIN ADHESIVE— 510(k) K141157

Substantially Equivalent

Optmed, Inc.

FDA 510(k) clearance K141157 for BONDEASE TOPICAL SKIN ADHESIVE, Substantially Equivalent on 2015-12-22. Applicant: Optmed, Inc..

Clearance details

Applicant: Optmed, Inc.
Product code: Code MPN
Advisory panel: General, Plastic Surgery
Date received: 2014-05-05
Decision date: 2015-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

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Adverse events under product code MPN

product code MPN

Injury: 856
Other: 1
Total: 857

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.