SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING— 510(k) K143001

Substantially Equivalent

Argentum Medical

FDA 510(k) clearance K143001 for SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING, Substantially Equivalent on 2014-11-07. Applicant: Argentum Medical.

Clearance details

Applicant: Argentum Medical
Product code: Code FRO
Advisory panel: Unknown
Date received: 2014-10-17
Decision date: 2014-11-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Geneva, IL, 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.