DeviceClearance

K143287

Substantially Equivalent

Fluidshield* Surgical Mask with Expanded Chamber

Applicant
Halyard Health, Inc.
Product code
FXX
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Alpharetta, GA, 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, through . 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.