510(k) Report

FDA applicant

Derma Sciences Canada, Inc.

Toronto, Orntario, CA3 decisions2006–20082 recalls

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, last Nov 3, 2026

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

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2026

2022: 12026 (partial year): 1
2007high 1 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Derma Sciences Canada, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Derma”

FDA records each applicant name separately; these may or may not be the same firm.