FDA applicant
Alm S.A.
FDA records 3 decisions for Alm S.A. (Rochester, NY) from 2003 to 2004: 3 510(k) clearances. All are in product code FSY (Light, Surgical, Ceiling Mounted). Its devices cite 3 predicates, 0 of them its own earlier devices. 7 recalls are linked to its devices.
FDA’s records also spell it “Alm”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Alm S.A.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Alm S.A. since 2007.
Recalls per year
2in 2023
Class I Class II/III not classified
Planning a device like Alm S.A.’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) Report