FDA applicant

Nortex USA, Inc.

Washington, DC1 decision1986–19860 recalls

FDA records 1 decision for Nortex USA, Inc. (Washington, DC) in 1986: 1 510(k) clearance. All are in product code EEJ (Guard, Disk). 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, dental panel, where it files most

How often FDA has decided Nortex USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nortex USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Nortex USA, Inc.

Which product codes does it file in?

What has FDA decided for it lately?