FDA applicant

Ceracarta Spa

Stillwater, MN1 decision2010–20100 recalls

FDA records 1 decision for Ceracarta Spa (Stillwater, MN) in 2010: 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 Ceracarta Spa’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Ceracarta Spa by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Ceracarta Spa

Which product codes does it file in?

What has FDA decided for it lately?