FDA applicant

Egnell, Inc.

Mchenry, IL10 decisions1981–19850 recalls

FDA records 10 decisions for Egnell, Inc. (Mchenry, IL) from 1981 to 1985: 10 510(k) clearances. Most are in product codes BTA (Pump, Portable, Aspiration (Manual Or Powered)) and FMZ (Incubator, Neonatal). 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 Egnell, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Egnell, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Egnell, 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?