Centerline Biomedical, Inc. - FDA 510(k) Cleared Devices

Centerline Biomedical, Inc. develops FDA-cleared endovascular navigation technology with a manufacturing facility in Cleveland, US. The company specializes in Cardiovascular devices designed to reduce radiation exposure and improve procedural accuracy during interventional procedures.

Centerline Biomedical has received 6 FDA 510(k) clearances from 6 total submissions since its first clearance in 2019. The company remains active, with its most recent clearance in 2026. All submissions focus on Cardiovascular devices, reflecting the company's core expertise in intra-operative positioning and navigation systems.

The company's primary technology platform is the Intra-Operative Positioning System (IOPS®), which provides real-time 3D image guidance and interactive navigation capabilities. This system addresses occupational hazards associated with traditional fluoroscopy-based procedures by significantly decreasing radiation exposure for interventional teams.

Explore the complete regulatory history, device names, product codes, and clearance dates in the database below.