FDA applicant
Aerogen (Ireland), Ltd.
FDA records 3 decisions for Aerogen (Ireland), Ltd. (Dangan Galway, IE) from 2007 to 2010: 3 510(k) clearances. All are in product code CAF (Nebulizer (Direct Patient Interface)). No recall is linked to its devices.
FDA’s records also spell it “Aerogen Ireland, Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Aerogen (Ireland), Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2010
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Aerogen (Ireland), Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Aerogen”
FDA records each applicant name separately; these may or may not be the same firm.