FDA applicant

Natus Nicolet Ireland, Ltd.

Gort, County Galway, IE1 decision2013–20131 recall

FDA records 1 decision for Natus Nicolet Ireland, Ltd. (Gort, County Galway, IE) in 2013: 1 510(k) clearance. All are in product code LGZ (Warmer, Thermal, Infusion Fluid). Its devices cite 1 predicate, 0 of them its own earlier devices. 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, general hospital panel, where it files most

How often FDA has decided Natus Nicolet Ireland, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2016

2013high 1 (2016) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Natus Nicolet Ireland, Ltd. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Natus Nicolet Ireland, Ltd.’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 Manufacturing Limited 4 Natus Medical Denmark Aps 1

Natus Nicolet Ireland, Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Natus”