FDA applicant

Eb Neuro S.P.A.

Indianpolis, IN13 decisions2001–20240 recalls

FDA records 13 decisions for Eb Neuro S.P.A. (Indianpolis, IN) from 2001 to 2024: 13 510(k) clearances. Most are in product codes GWL (Amplifier, Physiological Signal) and MNR (Ventilatory Effort Recorder). Its devices cite 22 predicates, 13 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, neurology panel, where it files most

How often FDA has decided Eb Neuro S.P.A.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2007high 2 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Eb Neuro S.P.A. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Eb Neuro S.P.A.

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?