SILVERMED ANTIMICROBIAL SILVER HYDROGEL— 510(k) K073019

Substantially Equivalent

Argentis Biomedical Incorporated

FDA 510(k) clearance K073019 for SILVERMED ANTIMICROBIAL SILVER HYDROGEL, Substantially Equivalent on 2008-09-16. Applicant: Argentis Biomedical Incorporated.

Clearance details

Applicant: Argentis Biomedical Incorporated
Product code: Code FRO
Advisory panel: Unknown
Date received: 2007-10-25
Decision date: 2008-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montvale, NJ, US

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.