FDA applicant

American Medtech

Washington, DC1 decision1997–19970 recalls

FDA records 1 decision for American Medtech (Washington, DC) in 1997: 1 510(k) clearance. All are in product code LKY (Device, External Penile Rigidity). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for American Medtech since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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American Medtech

Which product codes does it file in?

What has FDA decided for it lately?