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.
Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IrelandLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 9 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Mallinckrodt and its 19 subsidiaries with 172 510(k) clearances, 115 drug applications, 11 drug recalls, 10 device recalls and 2 complete response letters. The most recent is a 510(k) clearance dated Jan 3, 2025: EVOLVE Nitric Oxide 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.: 310, 20 entities
510(k) clearances: 172
Drug applications: 115
Drug recalls: 11
Device recalls: 10
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Mallinckrodt and its 19 subsidiaries
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
42017Records4
220182018Records2vs 2017−2
62019Records6vs 2018+4
320202020Records3vs 2019−3
22021Records2vs 2020−1
520222022Records5vs 2021+3
62023Records6vs 2022+1
420242024Records4vs 2023−2
32025Records3vs 2024−1
420262026 to dateRecords4
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
