FDA applicant

Compumedics Neuro Science Pty, Ltd.

Findley, MN1 decision2000–20001 recall

FDA records 1 decision for Compumedics Neuro Science Pty, Ltd. (Findley, MN) in 2000: 1 510(k) clearance. All are in product code OLT (Non-Normalizing Quantitative…). 1 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, neurology panel, where it files most

How often FDA has decided Compumedics Neuro Science Pty, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Compumedics Neuro Science Pty, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Compumedics Neuro Science Pty, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Compumedics”

FDA records each applicant name separately; these may or may not be the same firm.

Compumedics Limited 9 Compumedics USA, Ltd. 3 Compumedics Ptd, Ltd. 1 Compumedics Germany Gmgh 1

Compumedics Neuro Science Pty, Ltd.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Compumedics”