510(k) Report

FDA applicant

Nordion International, Inc.

Kanata, Ontario, CA2 decisions1995–19960 recalls

FDA records 2 decisions for Nordion International, Inc. (Kanata, Ontario, CA) from 1995 to 1996: 2 510(k) clearances. All are in product code MOT (Irradiator, Blood To Prevent Graft Versus Host…). Its devices cite 1 predicate, 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

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

FDA decisions per year

No FDA decision for Nordion International, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Nordion International, 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?

  • MOTIrradiator, Blood To Prevent Graft Versus Host Disease2decisions

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K963497Gammacell 3000 Elan, Version 1.0 and Gammacell 1000 Elite, Version 1.0Nordion International, Inc. · 19961cites it
  • K952291Gammacell 3000 ElanNordion International, Inc. · 19951cites it

What has FDA decided for it lately?

  • K963497Gammacell 3000 Elan, Version 1.0 and Gammacell 1000 Elite, Version 1.0Nordion International, Inc. · 1996
  • K952291Gammacell 3000 ElanNordion International, Inc. · 1995

All 2 as Nordion International, Inc. →