FDA Device Intelligence
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Mask, Gas, Anesthetic

FDA product code BSJ · Class 1 · Anesthesiology

1,222
Registered devices
115
Adverse events
1
Recalls
51
510(k) clearances

Devices with this code

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

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.