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-sonnet-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 INO Therapeutics with 15 510(k) clearances and 5 device recalls. The most recent is a device recall dated Jul 9, 2018: Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage; De….
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.
| Jul 9, 2018 | Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage; Device Classification: The INOmeter is an accessory toClass II · INOmeters affixed to the INOflo cylinders in Lot 17FP-0570 were programmed with an incorrect expiration date (11/2017). | Device recalls |
| May 2, 2013 | INOMAX DSIR (DELIVERY SYSTEM)K130605 · MRN | 510(k) clearances |
| Nov 7, 2012 | INOBLENDERK122689 · MRO | 510(k) clearances |
| Sep 24, 2012 | INOMAX DS (DELIVERY SYSTEM)K121021 · MRN | 510(k) clearances |
| Feb 29, 2012 | INOMAX DS(DELIVERY SYSTEMSK113272 · MRN | 510(k) clearances |
| Jun 24, 2011 | INOMAX DSIR (DELIVERY SYSTEM)K110344 · MRN | 510(k) clearances |
| Jun 23, 2011 | INOMAX DS(IR) (DELIVERY SYSTEM)K110635 · MRN | 510(k) clearances |
| Apr 15, 2010 | INOMAX DSK093922 · MRN | 510(k) clearances |
| Mar 10, 2010 | INOMAX DS (DELIVERY SYSTEM), MODEL 10003K092545 · MRN | 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
