4 results
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16ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·October 30, 2013
Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter laboratory table. Product Usage: The Sensei X Robotic Catheter System is an electromechanical software controlled system designed to facilitate navigation and control of Hansen Medicals robotically steerable catheters for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems.
FDA Enforcement
Class II
·Terminated·Hansen Medical Inc·January 7, 2015
Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
FDA Enforcement
Class II
·Terminated·Hansen Medical Inc·April 22, 2015
Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical Magellan System is a robotic control system that enables positioning and visualization of a Magellan Catheter and an off-the-shelf guide wire while allowing a physician to remain seated and away from the x-ray radiation source. The Accessory Kits contain disposable components that keep the Magellan Catheters and 3rd-party guide wires performing smoothly during system operation.
FDA Enforcement
Class II
·Terminated·Hansen Medical Inc·May 4, 2016