510(k) Report

FDA applicant

Odam

France, FR6 decisions1983–19980 recalls

FDA records 6 decisions for Odam (France, FR) from 1983 to 1998: 6 510(k) clearances. Most are in product codes LDD (Dc-Defibrillator, Low-Energy, (Including…) and MHX (Monitor, Physiological, Patient (With…). Its devices cite 5 predicates, 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

FIG. A — Illustration, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Odam since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Odam 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?

  • LDDDc-Defibrillator, Low-Energy, (Including Paddles)3decisions
  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)2decisions
  • DYCVectorcardiograph1decision

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

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.

What has FDA decided for it lately?

All 6 as Odam →