510(k) Report

FDA applicant

Mayaguez Medical Center

Trophy Club, TX10 decisions1993–19930 recalls

FDA records 10 decisions for Mayaguez Medical Center (Trophy Club, TX) in 1993: 10 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and GCY (Apparatus, Suction, Single Patient Use…). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Mayaguez Medical Center’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mayaguez Medical Center since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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