FDA applicant
Armstrong Medical, Ltd.
FDA records 1 decision for Armstrong Medical, Ltd. (Coleraine, IE) in 2012: 1 510(k) clearance. All are in product code CAF (Nebulizer (Direct Patient Interface)). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Armstrong Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2012
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like Armstrong Medical, 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 “Armstrong”
FDA records each applicant name separately; these may or may not be the same firm.