510(k) Report

FDA applicant

General Medical Mfg. Co.

Richmond, VA1 decision1994–19940 recalls

FDA records 1 decision for General Medical Mfg. Co. (Richmond, VA) in 1994: 1 510(k) clearance. All are in product code MLW (Warmer, Peritoneal Dialysate). 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 General Medical Mfg. Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for General Medical Mfg. Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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