Bracco Injeneering S.A.

FDA Regulatory Profile

Bracco Injeneering S.A. appears in FDA public data with 1 recall, 2 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0654-2019, Class II) was initiated on November 12, 2018. Its most recent 510(k) clearance was granted on January 22, 2016.

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0654-2019Class IIEmpower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT¿, EmpoweNovember 12, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K151048CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient SetJanuary 22, 2016
K133147BRACCO INJEENERING TRANSFER SETJune 20, 2014