510(k) Report

FDA applicant

Med-Dex Intl.

Irvine, CA4 decisions1988–19890 recalls

FDA records 4 decisions for Med-Dex Intl. (Irvine, CA) from 1988 to 1989: 4 510(k) clearances. Most are in product codes LDQ (Unnamed device) and KGX (Tape And Bandage, Adhesive). 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-Dex Intl.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Med-Dex Intl. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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