FDA applicant
Dermatec, Inc.
FDA records 4 decisions for Dermatec, Inc. (Trumbull, CT) from 1983 to 1986: 4 510(k) clearances. All are in product code NAD (Dressing, Wound, Occlusive). 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 Dermatec, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Dermatec, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Dermatec, 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) Report