510(k) Report

FDA applicant

Promedex, Inc.

Fort Woth, TX3 decisions1990–19910 recalls

FDA records 3 decisions for Promedex, Inc. (Fort Woth, TX) from 1990 to 1991: 3 510(k) clearances. Most are in product codes MFD (Cannula, Intrauterine Insemination) and KYA (System, Thermographic, Liquid Crystal…). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Promedex, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Promedex, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Promedex, Inc.’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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