FDA applicant

Flexmedics

Minneapolis, MN20 decisions1986–19990 recalls

FDA records 20 decisions for Flexmedics (Minneapolis, MN) from 1986 to 1999: 20 510(k) clearances. Most are in product codes EJF (Bracket, Metal, Orthodontic) and DQX (Wire, Guide, Catheter). Its devices cite 2 predicates, 1 of them its own earlier devices. 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, dental panel, where it files most

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

FDA decisions per year

No FDA decision for Flexmedics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Flexmedics

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?