FDA applicant

Fabersanitas, S.A.

15-50004 Zaragoza-Spain, ES3 decisions1985–19850 recalls

FDA records 3 decisions for Fabersanitas, S.A. (15-50004 Zaragoza-Spain, ES) in 1985: 3 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and GAA (Needle, Aspiration And Injection, Disposable). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Fabersanitas, S.A. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Fabersanitas, S.A.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Fabersanitas, S.A.

Which product codes does it file in?

What has FDA decided for it lately?