FDA applicant
Dideco S.P.A.
FDA records 33 decisions for Dideco S.P.A. (Waltham, MA) from 1995 to 2005: 33 510(k) clearances. Most are in product codes DTZ (Oxygenator, Cardiopulmonary Bypass) and CAC (Apparatus, Autotransfusion). Its devices cite 46 predicates, 23 of them its own earlier devices. 12 recalls are linked to its devices.
FDA’s records also spell it “Dideco S.R.L.”, “Dideco”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Dideco S.P.A.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Dideco S.P.A. since 2007.
Recalls per year
7in 2011
Class I Class II/III not classified
Planning a device like Dideco S.P.A.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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