K232806

Substantially Equivalent

HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388)

Applicant: Owens & Minor (O&M) Halyard, Inc.
Product code: FXX
Advisory panel: General, Plastic Surgery
Date received: 2023-09-12
Decision date: 2024-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mechanicsville, VA, US

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.