FDA applicant

Omnitron Intl., Inc.

Lajke Charles, LA7 decisions1988–19920 recalls

FDA records 7 decisions for Omnitron Intl., Inc. (Lajke Charles, LA) from 1988 to 1992: 7 510(k) clearances. Most are in product codes JAQ (System, Applicator, Radionuclide…) and KXK (Source, Brachytherapy, Radionuclide). 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Omnitron Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Omnitron Intl., Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?