AESDEX
AESDEX appears in FDA public data with 2 recalls, 0 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2433-2018, Class II) was initiated on April 2, 2018.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 0
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2433-2018 | Class II | AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100. The Cardica C | April 2, 2018 |
| Z-2434-2018 | Class II | AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number: FG-000150 The | April 2, 2018 |