FDA applicant

American Medical Electronics, Inc.

Richardson, TX14 decisions1989–19950 recalls

FDA records 14 decisions for American Medical Electronics, Inc. (Richardson, TX) from 1989 to 1995: 14 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and JDR (Staple, Fixation, Bone). 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, orthopedic panel, where it files most

How often FDA has decided American Medical Electronics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Medical Electronics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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American Medical Electronics, Inc.

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?