17 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Cardica C-Port xA Plus Anastomosis System
FDA UDI
AESDEX, LLC·11814900001007·C-Port xA Plus Anastomosis System
Cardica PAS-Port Proximal Anastomosis System
FDA UDI
AESDEX, LLC·11814900000017·PAS-Port Proximal Anastomosis System
Cardica C-Port Flex-A Plus Distal Anastomosis System
FDA UDI
AESDEX, LLC·11814900001502·C-Port FLEX-A Plus Distal Anastomosis System
MicroCutter 30 Curved Tip White Reload
FDA UDI
AESDEX, LLC·11814900003117·MicroCutter 30 Curved Tip White Reload is compa...
Dextera MicroCutter 5/80 Stapler
FDA UDI
AESDEX, LLC·11814900003025·Endoscopic Surgical Stapler
MicroCutter 30 White Reload
FDA UDI
AESDEX, LLC·11814900003100·MicroCutter 30 White Reload is compatible with ...
MicroCutter 30 Curved Tip Blue Reload
FDA UDI
AESDEX, LLC·11814900003216·MicroCutter 30 Curved Tip Blue Reload is compat...
Cardica Vein/Aorta Gauge
FDA UDI
AESDEX, LLC·11814900000031·The Vein/Aorta Gauge is a product that will ass...
MicroCutter 30 Blue Reload
FDA UDI
AESDEX, LLC·11814900003209·MicroCutter 30 Blue Reload is compatible with t...
CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
FDA Adverse Event
Death
·AESDEX, LLC·Product code FZP·May 15, 2020
CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
FDA Adverse Event
Injury
·AESDEX, LLC·Product code FZP·February 14, 2019
CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
FDA Adverse Event
Injury
·AESDEX, LLC·Product code FZP·March 3, 2020
CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
FDA Adverse Event
Injury
·AESDEX, LLC·Product code FZP·July 12, 2019
AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100. The Cardica C-Port xA PLUS Anastomosis System, delivers a series of clips that create an anastomosis between a small target vessel (e.g. coronary artery) and conduit (e.g. saphenous vein graft). The stainless steel clips create a complete end-to-side anastomosis that is functionally equivalent to a hand-sutured interrupted stitch anastomosis. The system consists of one Anastomosis Device and one Retractor Mount.
FDA Recall
Terminated
·AESDEX·Product code FZP·April 2, 2018
AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number: FG-000150 The Cardica C-Port Flex-A PLUS Distal Anastomosis System, delivers a series of clips that create an anastomosis between a small target vessel and conduit. The stainless steel clips create a complete end-to-side anastomosis that is functionally equivalent to a hand-sutured interrupted stitch anastomosis. The system consists of one Anastomosis Device and one Retractor Mount. The system is designed with a flexible shaft to facilitate access to difficult to reach coronary targets.
FDA Recall
Terminated
·AESDEX·Product code FZP·April 2, 2018
AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100. The Cardica C-Port xA PLUS Anastomosis System, delivers a series of clips that create an anastomosis between a small target vessel (e.g. coronary artery) and conduit (e.g. saphenous vein graft). The stainless steel clips create a complete end-to-side anastomosis that is functionally equivalent to a hand-sutured interrupted stitch anastomosis. The system consists of one Anastomosis Device and one Retractor Mount.
FDA Enforcement
Class II
·Terminated·AESDEX·July 25, 2018
AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number: FG-000150 The Cardica C-Port Flex-A PLUS Distal Anastomosis System, delivers a series of clips that create an anastomosis between a small target vessel and conduit. The stainless steel clips create a complete end-to-side anastomosis that is functionally equivalent to a hand-sutured interrupted stitch anastomosis. The system consists of one Anastomosis Device and one Retractor Mount. The system is designed with a flexible shaft to facilitate access to difficult to reach coronary targets.
FDA Enforcement
Class II
·Terminated·AESDEX·July 25, 2018