BURTON MEDICALFebruary 20, 2026

FDA 483 - BURTON MEDICAL - February 20, 2026

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Record Details

An FDA inspection of BURTON MEDICAL in Addison, IL, a manufacturer of medical devices, identified one significant observation. The firm failed to provide required information to the Global Unique Device Identification Database by not registering its APEX LED Class II surgical light device. This indicates a compliance issue related to device identification and tracking.

Company: BURTON MEDICAL
Inspection Date: February 20, 2026
Product Type: Device
Office: FDA District Office — Chicago, Illinois
Person: Hammam A. Abdallah

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