FDA applicant
Axcan Scientific Corp.
FDA records 5 decisions for Axcan Scientific Corp. (Walker, MI) from 1982 to 1984: 5 510(k) clearances. Most are in product codes HFF (Aspirator, Endometrial) and HIG (Insufflator, Hysteroscopic). 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 Axcan Scientific Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Axcan Scientific Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Axcan Scientific Corp.’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