AESDEX

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2433-2018Class IIAesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100. The Cardica CApril 2, 2018
Z-2434-2018Class IIAesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number: FG-000150 TheApril 2, 2018