FDA applicant

Biosystems Assoc.

La Jolla, CA1 decision1985–19850 recalls

FDA records 1 decision for Biosystems Assoc. (La Jolla, CA) in 1985: 1 510(k) clearance. All are in product code FRO (Dressing, Wound, Drug). No recall is linked to its devices.

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

How often FDA has decided Biosystems Assoc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biosystems Assoc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Biosystems”

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

Biosystems S.A. 7

Biosystems Assoc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Biosystems”