Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Bracco ImagingLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Bracco Diagnostics with 13 drug recalls and 5 510(k) clearances. The most recent is a 510(k) clearance dated Mar 3, 2025: HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow ….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 3, 2025 | HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4K243881 · KPS | 510(k) clearances |
| Jun 12, 2018 | HeartSee Cardiac P.E.T. Processing SoftwareK181343 · KPS | 510(k) clearances |
| Mar 8, 2018 | E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manufactured by E-Z-EM Canada Inc. for E-Z-EM Inc. a subsidiary oClass II · Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during sta | Drug recalls |
| Feb 14, 2014 | BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATORK132192 · FCX | 510(k) clearances |
| Aug 6, 2013 | BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SETK123047 · FCX | 510(k) clearances |
| Nov 3, 2011 | BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATORK111648 · FCX | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
