510(k) Report

FDA applicant

Medennium, Inc.

Irvine, CA1 decision2002–20020 recalls

FDA records 1 decision for Medennium, Inc. (Irvine, CA) in 2002: 1 510(k) clearance. All are in product code LZU (Plug, Punctum). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

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

FDA decisions per year

No FDA decision for Medennium, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • LZUPlug, Punctum1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K022043Smart Plug, Model 500; Smartplug Forceps, Model 502; Push Rod, Model 503Medennium, Inc. · 20022cite it

What has FDA decided for it lately?

  • K022043Smart Plug, Model 500; Smartplug Forceps, Model 502; Push Rod, Model 503Medennium, Inc. · 2002

The one decision as Medennium, Inc. →