Stereotaxis, Inc. - FDA 510(k) Cleared Devices

Stereotaxis, Inc. is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. The company develops robotic systems, instruments, and information solutions for the interventional laboratory. Stereotaxis operates with a manufacturing facility in St. Louis, Missouri.

The company has received 28 FDA 510(k) clearances from 28 total submissions, with no denied submissions on record. Cardiovascular devices represent 89% of the company's regulatory portfolio. Stereotaxis has maintained continuous FDA 510(k) activity since its first clearance in 2002, with the most recent clearance in 2026, demonstrating sustained innovation and market presence.

The company's cleared device portfolio includes robotic magnetic navigation systems, steerable catheter control systems, and robotically navigated mapping and ablation catheters. Recent clearances include the GenesisX and Genesis robotic systems, the MAGiC Sweep EP mapping catheter, and the Synchrony workstation platform. These technologies support cardiac ablation, electrophysiology mapping, and interventional cardiology procedures.

Explore the complete list of device names, product codes, and clearance dates in the 510(k) database to review Stereotaxis's full regulatory history.

510(k) submissions have been managed by Access Point Technologies as regulatory consultant.