FDA applicant

Med Gen, Inc.

Boca Raton, FL2 decisions2001–20010 recalls

FDA records 2 decisions for Med Gen, Inc. (Boca Raton, FL) in 2001: 2 510(k) clearances. Most are in product codes FQM (Bandage, Elastic) and FMQ (Restraint, Protective). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Med Gen, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Med Gen, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Med Gen, 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?