510(k) Report

FDA applicant

Ensi-Med International Pty., Ltd.

Seaford, Victoria, AU1 decision2001–20010 recalls

FDA records 1 decision for Ensi-Med International Pty., Ltd. (Seaford, Victoria, AU) in 2001: 1 510(k) clearance. All are in product code MEG (Syringe, Antistick). 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 Ensi-Med International Pty., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ensi-Med International Pty., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ensi-Med International Pty., Ltd. 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?

  • MEGSyringe, Antistick1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K003348E.N.S.I. Retractable Safety SyringeEnsi-Med International Pty., Ltd. · 20013cite it

What has FDA decided for it lately?

  • K003348E.N.S.I. Retractable Safety SyringeEnsi-Med International Pty., Ltd. · 2001

The one decision as Ensi-Med International Pty., Ltd. →