FDA applicant

Nexstim OY

Helsinki, FI4 decisions2009–20192 recalls

FDA records 4 decisions for Nexstim OY (Helsinki, FI) from 2009 to 2019: 4 510(k) clearances. Most are in product codes GWF (Stimulator, Electrical, Evoked Response) and OBP (Transcranial Magnetic Stimulator). Its devices cite 5 predicates, 2 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Nexstim Plc”.

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 Nexstim OY’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

2in 2017

2009high 2 (2017) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Nexstim OY by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nexstim OY’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 “Nexstim”

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

Nexstim Oyj 2

Nexstim OY

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?

What has been recalled?

Other applicant names beginning “Nexstim”