FDA applicant

Esi, Inc.

Hasbrouck Heights, NJ3 decisions1981–20080 recalls

FDA records 3 decisions for Esi, Inc. (Hasbrouck Heights, NJ) from 1981 to 2008: 3 510(k) clearances. Most are in product codes ITX (Transducer, Ultrasonic, Diagnostic) and IWJ (System, Applicator, Radionuclide, Manual). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Esi”.

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

FIG. A — Illustration, radiology panel, where it files most

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

FDA decisions per year

2in 2008

2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Esi, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?