FDA applicant
Neuro-Diagnostic Assoc.
FDA records 2 decisions for Neuro-Diagnostic Assoc. (Laguna Beach, CA) from 1997 to 1998: 2 510(k) clearances. Most are in product codes GWF (Stimulator, Electrical, Evoked Response) and LLN (Device, Vibration Threshold Measurement). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Neuro-Diagnostic Assoc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Neuro-Diagnostic Assoc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Neuro-Diagnostic Assoc.’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 “Neuro-Diagnostic”
FDA records each applicant name separately; these may or may not be the same firm.