FDA applicant

Esaote Europe B.V.

Carmel, IN7 decisions2006–20160 recalls

FDA records 7 decisions for Esaote Europe B.V. (Carmel, IN) from 2006 to 2016: 7 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and ITX (Transducer, Ultrasonic, Diagnostic). Its devices cite 27 predicates, 6 of them its own earlier devices. 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 Europe B.V.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Esaote Europe B.V.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

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 Biomedica Spa 4 Esaote Biomedica Elettronica 1

Esaote Europe B.V.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Esaote”