FDA applicant

Corcym S.r.l.

Saluggia, IT5 decisions1993–20261 recall

FDA records 5 decisions for Corcym S.r.l. (Saluggia, IT) from 1993 to 2026: 3 510(k) clearances and 2 original PMA approvals. Most are in product codes KRH (Ring, Annuloplasty) and LWR (Heart-Valve, Non-Allograft Tissue). Its devices cite 5 predicates, 1 of them its own earlier devices. 1 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, cardiovascular panel, where it files most

How often FDA has decided Corcym S.r.l.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007high 2 (2026) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2016

2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Corcym S.r.l.’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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Other applicant names beginning “Corcym”

FDA records each applicant name separately; these may or may not be the same firm.

Corcym Canada Corp 2

Corcym S.r.l.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Corcym”