FDA applicant
Derma Sciences Canada, Inc.
FDA records 3 decisions for Derma Sciences Canada, Inc. (Toronto, Orntario, CA) from 2006 to 2008: 3 510(k) clearances. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 1 predicate, 1 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Derma Sciences Canada, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2008
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Derma Sciences Canada, Inc.’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 “Derma”
FDA records each applicant name separately; these may or may not be the same firm.