FDA applicant

American Medical Corp.

Minnetonka, MN3 decisions1991–19920 recalls

FDA records 3 decisions for American Medical Corp. (Minnetonka, MN) from 1991 to 1992: 3 510(k) clearances. Most are in product codes FAE (Prosthesis, Penile) and BXB (Exerciser, Powered). 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 Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Medical Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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American Medical Corp.

Which product codes does it file in?

What has FDA decided for it lately?