FDA applicant

Regtec

St. Petersburg, FL1 decision1986–19860 recalls

FDA records 1 decision for Regtec (St. Petersburg, FL) in 1986: 1 510(k) clearance. All are in product code GDB (Endoscope, Fiber Optic). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Regtec since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Regtec

Which product codes does it file in?

What has FDA decided for it lately?