FDA applicant

Biosystems S.A.

Barcelona, ES7 decisions1995–20200 recalls

FDA records 7 decisions for Biosystems S.A. (Barcelona, ES) from 1995 to 2020: 7 510(k) clearances. Most are in product codes MMK (Container, Sharps) and DDG (Transferrin, Antigen, Antiserum, Control). No recall is linked to its devices.

FDA’s records also spell it “Biosystems”.

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 Biosystems S.A.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2020

2007high 2 (2020) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Biosystems 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

Other applicant names beginning “Biosystems”

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

Biosystems Assoc. 1

Biosystems S.A.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Biosystems”