FDA applicant

Galix Instrumentacion Biomedica

Buenos Aires, AR2 decisions1991–19910 recalls

FDA records 2 decisions for Galix Instrumentacion Biomedica (Buenos Aires, AR) in 1991: 2 510(k) clearances. All are in product code DSH (Recorder, Magnetic Tape, Medical). 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, cardiovascular panel, where it files most

How often FDA has decided Galix Instrumentacion Biomedica’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Galix Instrumentacion Biomedica since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Galix”

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

Galix Biomedical Instrumentation, Inc. 6

Galix Instrumentacion Biomedica

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Galix”