4 results
·
6ms
·
Sources: EU EUDAMED, US FDA
WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
FDA Enforcement
Class I
·Terminated·Biosense Webster, Inc.·September 5, 2018
TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).
FDA Enforcement
Class I
·Terminated·Laax, Inc.·April 29, 2015
TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).
FDA Enforcement
Class I
·Terminated·Laax, Inc.·April 29, 2015
CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is suitable for service in hospital, transport and homecare as a source of continuous or intermittent positive pressure ventilator support, delivered invasively or non-invasively. These ventilators are restricted medical devices intended for operation by a trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations.
FDA Enforcement
Class I
·Terminated·CareFusion 203, Inc.·October 1, 2014