FDA approved systems - listing
The Surgical Robotics Technology site has a list of FDA cleared surgical robot systems: "FDA approval means that the U.S. Food and Drug Administration has reviewed the robot’s safety, effectiveness, and performance for specific surgical procedures. Most surgical robots are cleared through the FDA’s 510(k) process, which requires them to be substantially equivalent to an existing approved device. This clearance ensures the robot meets regulatory standards for use in surgery, but it doesn’t guarantee better outcomes or apply to every type of procedure. It means the device can be legally marketed and used for its approved indications." Source: Surgicalroboticstechnology.com







