FDA applicant

Bertone & Assoc.

Mchenry, IL1 decision1983–19830 recalls

FDA records 1 decision for Bertone & Assoc. (Mchenry, IL) in 1983: 1 510(k) clearance. All are in product code GZK (Electrode, Nasopharyngeal). 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, neurology panel, where it files most

How often FDA has decided Bertone & Assoc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bertone & Assoc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Bertone & Assoc.

Which product codes does it file in?

What has FDA decided for it lately?