CELOX PRO, CELOX PRO OTC, CELOX HEMOSTATIC GRANULES, CELOX PRO HEMOSTATIC GRANULES, OMNI STAT PRO— 510(k) K093593

Substantially Equivalent

Medtrade Products Limited

FDA 510(k) clearance K093593 for CELOX PRO, CELOX PRO OTC, CELOX HEMOSTATIC GRANULES, CELOX PRO HEMOSTATIC GRANULES, OMNI STAT PRO, Substantially Equivalent on 2010-01-20. Applicant: Medtrade Products Limited.

Clearance details

Applicant: Medtrade Products Limited
Product code: Code QSY
Advisory panel: Unknown
Date received: 2009-11-19
Decision date: 2010-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crewe, Cheshire, GB

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.