1 device · 1 company · 2026
Product code GWF: Stimulator, Electrical, Evoked Response
1 device under product code GWF, 2026, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Stimulator, Electrical, Evoked Response. 21 CFR 882.1870, Class II. MAUDE held 3,348 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| SafeOp 3: Neural Informatix SystemK252842 · 510(k) | Alphatec Spine, Inc. | Neurology | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.