FDA applicant
Medelec, Ltd.
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
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
Class I Class II/III not classified
Planning a device like Medelec, 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) ReportOther applicant names beginning “Medelec”
FDA records each applicant name separately; these may or may not be the same firm.