FDA applicant

Esaote Biomedica Elettronica

Cambridge, MA1 decision1989–19890 recalls

FDA records 1 decision for Esaote Biomedica Elettronica (Cambridge, MA) in 1989: 1 510(k) clearance. All are in product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Esaote Biomedica Elettronica since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Esaote Biomedica Elettronica 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 Spa 4

Esaote Biomedica Elettronica

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Esaote”