510(k) Report

FDA applicant

Fidia Farmaceutici S.P.A.

Abano Terme6 decisions1997–20200 recalls

FDA records 6 decisions for Fidia Farmaceutici S.P.A. (Abano Terme) from 1997 to 2020: 3 510(k) clearances and 3 original PMA approvals. Most are in product codes MOZ (Acid, Hyaluronic, Intraarticular) and NUC (Lubricant, Personal). Its devices cite 5 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Fidia Farmaceutici”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

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

FDA decisions per year

1in 2020

2010: 12015: 22019: 12020: 1
2007high 2 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Fidia Farmaceutici 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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Other applicant names beginning “Fidia”

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