FDA Device Intelligence
HomeMERCURY ENTERPRISES, INC. › Deluxe Full Face Mask

Deluxe Full Face Mask

MERCURY ENTERPRISES, INC. · Model 10-57100 · UDI-DI 10641043571002

BSJ Prescription
10
510(k) clearances
115
Adverse events
1
Recalls
161
Facilities

Recalls

DateFirmReason
2011-09-12Engineered Medical Systems,IncThe mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.