Bracco Injeneering S.A.
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 2
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0654-2019 | Class II | Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT¿, Empowe | November 12, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K151048 | CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set | January 22, 2016 |
| K133147 | BRACCO INJEENERING TRANSFER SET | June 20, 2014 |