510(k) General Hospital Devices

FDA 510(k) Cleared General Hospital Devices

This page lists all 17707 medical devices in the General Hospital specialty that have been submitted to the FDA through the 510(k) premarket notification process. Infusion pumps, IV sets, syringes and general-purpose hospital equipment.

• 17683 devices cleared as substantially equivalent to a predicate device.
• Average time to FDA decision: 128 days.
• Records available from 1976 to the present.
• Filter by product code using the sidebar to narrow results by device type.