TOPSEAL HEMOSTATIC DRESSING, MODEL 11150— 510(k) K033291

Substantially Equivalent

Radi Medical Systems AB

FDA 510(k) clearance K033291 for TOPSEAL HEMOSTATIC DRESSING, MODEL 11150, Substantially Equivalent on 2004-03-17. Applicant: Radi Medical Systems AB.

Clearance details

Applicant: Radi Medical Systems AB
Product code: Code QSY
Advisory panel: Unknown
Date received: 2003-10-14
Decision date: 2004-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uppsala, SE

Download summary PDF View on FDA.gov ↗

Adverse events under product code QSY

product code QSY

Death: 5
Other: 1
Total: 6

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.