FDA applicant

Esa, Inc.

Bedford, MA7 decisions1987–20043 recalls

FDA records 7 decisions for Esa, Inc. (Bedford, MA) from 1987 to 2004: 7 510(k) clearances. Most are in product codes CHQ (Chromatographic/Fluorometric Method…) and LEQ (Detectors, Electrochemical, Liquid…). 3 recalls are linked to its devices, 1 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Esa, Inc. since 2007.

Recalls per year

1in 2018

2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

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Esa, 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?

What has been recalled?