FDA applicant

American Pacemaker Corp.

Mchenry, IL14 decisions1977–19820 recalls

FDA records 14 decisions for American Pacemaker Corp. (Mchenry, IL) from 1977 to 1982: 14 510(k) clearances. Most are in product codes DXY (Implantable Pacemaker Pulse-Generator) and DTB (Permanent Pacemaker Electrode). 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 American Pacemaker Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Pacemaker Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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American Pacemaker Corp.

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?