CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING— 510(k) K120930

Substantially Equivalent

Medtrade Products , Ltd.

FDA 510(k) clearance K120930 for CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING, Substantially Equivalent on 2012-10-26. Applicant: Medtrade Products , Ltd..

Clearance details

Applicant: Medtrade Products , Ltd.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2012-03-27
Decision date: 2012-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheshire, GB

Download summary PDF View on FDA.gov ↗

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.