FDA applicant
Wilshire Medical Products
FDA records 12 decisions for Wilshire Medical Products (Dallas, TX) from 1993 to 1995: 12 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and MGQ (Dressing, Wound And Burn, Hydrogel W/Drug…). Its devices cite 5 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 Wilshire Medical Products’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Wilshire Medical Products since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Wilshire Medical Products’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 “Wilshire”
FDA records each applicant name separately; these may or may not be the same firm.