43 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PVH and ASK-15703-PNYP
FDA Enforcement
Class II
·Terminated·Arrow International Inc·June 6, 2018
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PVH and ASK-15703-PNYP
FDA Recall
Terminated
·Arrow International Inc·Product code FOZ·April 11, 2018
Precision Bipolar Device ClearGlide EVH Small (endoscopic vessel harvesting system) The kit included three Precision BiPolar Devices, an Optical Vessel Dissector, a Small Ultra Retractor and a Vessel Dissector. Datascope Cardiac Assist Sterile R Manufactured for: Datascope Cardiac Assist 15 Law Drive Fairfield, NJ 07004
FDA Recall
Terminated
·Datascope Corporation·Product code GEI·May 7, 2007
The ClearGlide EVH small with Scissors. The kit includes three Precision Bipolar Devices, an Optical Vessel Dissector, a Small Ultra Retractor, a Vessel Dissector, and the ENDOPATH 5mm curved scissors. Datascope Cardiac Assist Sterile Manufactured for: Datascope Cardiac Assist 15 Law Drive Fairfield, NJ 07004
FDA Recall
Terminated
·Datascope Corporation·Product code GEI·May 7, 2007
Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470 Indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels oft he extremities, dissection of ducts and other structures int he extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external to the parietal pleura including nerves blood vessels and other tissues of the chest wall.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code GEI·October 30, 2013
Sorin / Clearglide EVH Long View, REF KTV22, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004. The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of blood vessels. Device is a single patient use bipolar instrument that uses a bipolar electrosurgical generator and is used predominately for endoscopic harvesting of the saphenous vein from the leg for coronary bypass surgery.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code GEI·November 25, 2009
Sorin / Clearglide EVH Low Profile, REF KTV16, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004. The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of blood vessels. Device is a single patient use bipolar instrument that uses a bipolar electrosurgical generator and is used predominately for endoscopic harvesting of the saphenous vein from the leg for coronary bypass surgery.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code GEI·November 25, 2009
Sorin / Clearglide EVH Small, REF KTV15, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004. The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of blood vessels. Device is a single patient use bipolar instrument that uses a bipolar electrosurgical generator and is used predominately for endoscopic harvesting of the saphenous vein from the leg for coronary bypass surgery.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code GEI·November 25, 2009
Sorin / Clearglide EVH Small with Scissor, REF KTV17, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004. The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of blood vessels. Device is a single patient use bipolar instrument that uses a bipolar electrosurgical generator and is used predominately for endoscopic harvesting of the saphenous vein from the leg for coronary bypass surgery.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code GEI·November 25, 2009
Sorin / Clearglide EVH Low Profile with Scissor, REF KTV18, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004. The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of blood vessels. Device is a single patient use bipolar instrument that uses a bipolar electrosurgical generator and is used predominately for endoscopic harvesting of the saphenous vein from the leg for coronary bypass surgery.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code GEI·November 25, 2009
Sorin / Clearglide EVH Long View with Scissor, REF KTV23, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004. The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of blood vessels. Device is a single patient use bipolar instrument that uses a bipolar electrosurgical generator and is used predominately for endoscopic harvesting of the saphenous vein from the leg for coronary bypass surgery.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code GEI·November 25, 2009
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Enforcement
Class II
·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Enforcement
Class II
·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Enforcement
Class II
·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Enforcement
Class II
·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Enforcement
Class II
·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Enforcement
Class II
·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Enforcement
Class II
·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101863MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Enforcement
Class II
·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Enforcement
Class II
·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020