FDA applicant

Regu-Tech Assoc., Inc.

Allendale, NJ3 decisions1996–19970 recalls

FDA records 3 decisions for Regu-Tech Assoc., Inc. (Allendale, NJ) from 1996 to 1997: 3 510(k) clearances. Most are in product codes HEB (Tampon, Menstrual, Unscented) and KKO (Ring, Teething, Fluid-Filled). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Regu-Tech Assoc., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Regu-Tech Assoc., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Regu-Tech Assoc., Inc.

Which product codes does it file in?

What has FDA decided for it lately?