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 MallinckrodtLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Mallinckrodt Manufacturing LLC with 4 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Jan 3, 2025: EVOLVE Nitric Oxide Delivery System.
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.
| Jan 3, 2025 | EVOLVE Nitric Oxide Delivery SystemK242578 · MRN | 510(k) clearances |
| Dec 6, 2023 | Evolve Nitric Oxide Delivery SystemK222930 · MRN | 510(k) clearances |
| Aug 8, 2023 | Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.Class I · The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen. | Device recalls |
| Apr 20, 2023 | Inomax DSIRK211153 · MRN | 510(k) clearances |
| Jun 17, 2020 | INOmax DSIR PlusK200389 · MRN | 510(k) clearances |
| Oct 17, 2014 | Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC Adjunct to sutures inClass II · Product was improperly labeled leading to improper storage. | Device recalls |
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
