Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA files no records under this name; these are its 3 companies' records, each linked to the record.
As of Nov 15, 2026, FDA's public records list Bracco Imaging and its 3 subsidiaries with 31 510(k) clearances, 13 drug recalls and 4 device recalls. The most recent is a 510(k) clearance dated Aug 3, 2026: VueJect® Ultrasound Enhancing Agent Delivery System.
Group recordsLabelled by a language model (which subsidiaries belong to the group) from the firm's FDA names. It is not an FDA field.: 48, 4 entities
510(k) clearances: 31
Drug recalls: 13
Device recalls: 4
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Bracco Imaging and its 3 subsidiaries
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
22017Records2
420182018Records4vs 2017+2
32019Records3vs 2018−1
220202020Records2vs 2019−1
12021Records1vs 2020−1
020222022Records0vs 2021−1
02023Records0vs 2022+0
120242024Records1vs 2023+1
12025Records1vs 2024+0
320262026 to dateRecords3
Latest Records
Newest first across sources; each opens the record
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