510(k) Report

FDA applicant

Dermatec, Inc.

Trumbull, CT4 decisions1983–19860 recalls

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, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

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.

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

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.

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