FDA Product Code NEU: Marker, Radiographic, Implantable
Under FDA product code NEU, implantable radiographic markers are cleared for use in surgical and radiation oncology procedures.
These small metal clips or seeds are placed at the margins of surgical excision sites or tumor beds to provide a permanent radiographic landmark visible on X-ray, CT, and fluoroscopy for post-operative radiation targeting, surveillance imaging, and repeat surgery planning.
NEU devices are Class II medical devices, regulated under 21 CFR 878.4300 and reviewed by the FDA General & Plastic Surgery panel.
Leading manufacturers include Merit Medical Systems, Inc., Stryker Endoscopy and Bard Peripheral Vascular, Inc..
List of Marker, Radiographic, Implantable devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Marker, Radiographic, Implantable devices (product code NEU). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General & Plastic Surgery FDA review panel. Browse all General & Plastic Surgery devices →