FDA applicant

Natus Manufacturing Limited

Gort, IE4 decisions2015–20240 recalls

FDA records 4 decisions for Natus Manufacturing Limited (Gort, IE) from 2015 to 2024: 4 510(k) clearances. Most are in product codes IKT (Electrode, Needle, Diagnostic Electromyograph) and GXY (Electrode, Cutaneous). Its devices cite 4 predicates, 0 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, physical medicine panel, where it files most

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

FDA decisions per year

1in 2024

2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Natus Manufacturing Limited by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Natus Manufacturing Limited’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Natus”

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

Natus Medical, Inc. 23 Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) 13 Natus Neurology Incorporated 5 Natus Medical Denmark Aps 1 Natus Nicolet Ireland, Ltd. 1

Natus Manufacturing Limited

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Natus”