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BIG EASY, MASK

INNOVATION INSTITUTE, LLC · Model 33-90004 · UDI-DI 00850055775015

BSJ
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.

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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.