FDA applicant
Excel Tech., Ltd.
FDA records 58 decisions for Excel Tech., Ltd. (Oakville, CA) from 1985 to 2006: 58 510(k) clearances. Most are in product codes GWQ (Full-Montage Standard Electroencephalograph) and GEX (Powered Laser Surgical Instrument). Its devices cite 9 predicates, 6 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
How often FDA has decided Excel Tech., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Excel Tech., Ltd. since 2007.
Recalls per year
1in 2015
Class I Class II/III not classified
Planning a device like Excel Tech., 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 “Excel”
FDA records each applicant name separately; these may or may not be the same firm.