FDA applicant

Aea Srl

Angeli De Rosora, IT3 decisions2014–20210 recalls

FDA records 3 decisions for Aea Srl (Angeli De Rosora, IT) from 2014 to 2021: 3 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and LHI (Set, I.V. Fluid Transfer). Its devices cite 8 predicates, 0 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2021

2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Aea Srl by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Aea Srl

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?