TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE— 510(k) K080648

Substantially Equivalent

Ore-Medix, LLC

FDA 510(k) clearance K080648 for TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE, Substantially Equivalent on 2008-05-07. Applicant: Ore-Medix, LLC.

Clearance details

Applicant: Ore-Medix, LLC
Product code: Code QSY
Advisory panel: Unknown
Date received: 2008-03-07
Decision date: 2008-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Midvale, UT, US

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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.