MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY— 510(k) K110546

Substantially Equivalent

Derma Sciences, Inc.

FDA 510(k) clearance K110546 for MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY, Substantially Equivalent on 2011-07-27. Applicant: Derma Sciences, Inc..

Clearance details

Applicant: Derma Sciences, Inc.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2011-02-25
Decision date: 2011-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.