510(k) Obstetrics & Gynecology Devices

FDA 510(k) Cleared Obstetrics & Gynecology Devices

This page lists all 4453 medical devices in the Obstetrics & Gynecology specialty that have been submitted to the FDA through the 510(k) premarket notification process. Fetal monitors, breast pumps, IUDs and gynecological surgical instruments.

• 4440 devices cleared as substantially equivalent to a predicate device.
• Average time to FDA decision: 160 days.
• Records available from 1976 to the present.
• Filter by product code using the sidebar to narrow results by device type.