FDA Device Intelligence
Home › Drägerwerk AG & Co. KGaA › Mask ComfortStar6stand,w.hook

Mask ComfortStar6stand,w.hook

Drägerwerk AG & Co. KGaA · Model MP01516 · UDI-DI 04048675035640

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.

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.