FDA applicant

Galix Biomedical Instrumentation, Inc.

Miami Beach, FL6 decisions1998–20100 recalls

FDA records 6 decisions for Galix Biomedical Instrumentation, Inc. (Miami Beach, FL) from 1998 to 2010: 6 510(k) clearances. Most are in product codes MLO (Electrocardiograph, Ambulatory, With Analysis…) and DPS (Electrocardiograph). 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 Biomedical Instrumentation, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Galix Biomedical Instrumentation, Inc.’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 “Galix”

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

Galix Instrumentacion Biomedica 2

Galix Biomedical Instrumentation, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Galix”