Bracco Diagnostics Inc

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
2
Inspections
7
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0609-2018Class IIE-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manufactured by E-Z-EM CaMarch 8, 2018
D-1083-2014Class IIIVoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-December 16, 2013
D-914-2013Class IIITagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx OnJuly 19, 2013
D-885-2013Class IIGastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound IodJune 21, 2013
D-1684-2012Class IICARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogeniJune 1, 2012
D-1665-2012Class IIMultihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for April 16, 2012
D-1663-2012Class IIIBracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx only, ManufactApril 16, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFRMarch 3, 2025
K181343HeartSee Cardiac P.E.T. Processing SoftwareJune 12, 2018