FDA applicant

Esaote Biomedica Spa

Cambridge, MA4 decisions1990–19940 recalls

FDA records 4 decisions for Esaote Biomedica Spa (Cambridge, MA) from 1990 to 1994: 4 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and DXJ (Display, Cathode-Ray Tube, Medical). 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, cardiovascular panel, where it files most

How often FDA has decided Esaote Biomedica Spa’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Esaote Biomedica Spa since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Esaote”

FDA records each applicant name separately; these may or may not be the same firm.

Esaote, S.p.A. 69 Esaote Europe B.V. 7 Esaote Biomedica Elettronica 1

Esaote Biomedica Spa

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?

Other applicant names beginning “Esaote”