510(k) Report

FDA applicant

Wilshire Medical Products

Dallas, TX12 decisions1993–19950 recalls

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, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

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.

FIG. 1 — Wilshire Medical Products by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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Other applicant names beginning “Wilshire”

FDA records each applicant name separately; these may or may not be the same firm.