FDA applicant
Covalon Technologies, Ltd.
FDA records 4 decisions for Covalon Technologies, Ltd. (Waxhaw, NC) from 2006 to 2026: 4 510(k) clearances. Most are in product codes KGN (Wound Dressing With Animal-Derived Material (S)) and FRO (Dressing, Wound, Drug). Its devices cite 5 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Covalon Technologies, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2013
2026 so far, outlined.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Covalon Technologies, 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) Report