PRIMED Surgical Masks and PRIMED Procedure Masks— 510(k) K240286

Substantially Equivalent

Primed Medical Products, Inc.

FDA 510(k) clearance K240286 for PRIMED Surgical Masks and PRIMED Procedure Masks, Substantially Equivalent on 2024-08-26. Applicant: Primed Medical Products, Inc..

Clearance details

Applicant: Primed Medical Products, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2024-02-01
Decision date: 2024-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edmonton, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

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.