FDA applicant

Keilei Intl., Inc.

Dover, NJ5 decisions1989–19910 recalls

FDA records 5 decisions for Keilei Intl., Inc. (Dover, NJ) from 1989 to 1991: 5 510(k) clearances. Most are in product codes NAB (Gauze / Sponge,Nonresorbable For External Use) and FRO (Dressing, Wound, Drug). 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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Keilei 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?