FDA applicant

Intl. Business Machines

Mchenry, IL8 decisions1977–19830 recalls

FDA records 8 decisions for Intl. Business Machines (Mchenry, IL) from 1977 to 1983: 8 510(k) clearances. Most are in product codes GKT (Separator, Automated, Blood Cell, Diagnostic) and LOS (Unnamed device). 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, hematology panel, where it files most

How often FDA has decided Intl. Business Machines’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Intl. Business Machines since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Intl. Business Machines

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?