510(k) Report

FDA applicant

Medelec, Ltd.

Old Woking, Surrey, DE8 decisions1992–19971 recall

FDA records 8 decisions for Medelec, Ltd. (Old Woking, Surrey, DE) from 1992 to 1997: 8 510(k) clearances. Most are in product codes GWQ (Full-Montage Standard Electroencephalograph) and GWF (Stimulator, Electrical, Evoked Response). 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 Medelec, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medelec, Ltd. since 2007.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medelec, 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 “Medelec”

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