FDA applicant

Medel S.P.A.

Cary, NC4 decisions2006–20090 recalls

FDA records 4 decisions for Medel S.P.A. (Cary, NC) from 2006 to 2009: 4 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and HGX (Pump, Breast, Powered). 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, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2009

2007high 1 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Medel S.P.A.

Which product codes does it file in?

What has FDA decided for it lately?