510(k) Report

FDA applicant

The Magstim Company, Ltd.

Carmarthenshire, GB27 decisions1992–20256 recalls

FDA records 27 decisions for The Magstim Company, Ltd. (Carmarthenshire, GB) from 1992 to 2025: 27 510(k) clearances. Most are in product codes OBP (Transcranial Magnetic Stimulator) and ETN (Stimulator, Nerve). Since 2016 its 510(k)s took a median of 141 days from receipt to decision, against 132 for FDA’s reviews in the same codes and years. Its devices cite 37 predicates, 20 of them its own earlier devices. 6 recalls are linked to its devices.

FDA’s records also spell it “Magstim Company, Ltd.”, “The Magstim Company Limited”, “Magstim Company Limited”.

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 The Magstim Company, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2007: 12008: 12009: 12013: 12015: 12017: 22018: 22019: 22021: 22023: 32024: 12025: 2
2007high 3 (2023) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

4in 2020

2017: 12018: 12020: 4
2007high 4 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — The Magstim Company, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Other applicant names beginning “The”

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