Company ยท US
Mallinckrodt Manufacturing, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2020 to 2025. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 3, 2025 | K242578 | EVOLVE Nitric Oxide Delivery System Mallinckrodt Manufacturing, LLC | MRN |
| Dec 6, 2023 | K222930 | Evolve Nitric Oxide Delivery System Mallinckrodt Manufacturing, LLC | MRN |
| Apr 20, 2023 | K211153 | Inomax DSIR Mallinckrodt Manufacturing, LLC | MRN |
| Jun 17, 2020 | K200389 | INOmax DSIR Plus Mallinckrodt Manufacturing, LLC | MRN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 9, 2023 | Mallinckrodt Manufacturing LLC Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators. Open, Classified |
BZO | None listed |
| Jul 6, 2017 | Mallinckrodt Manufacturing LLC Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC
Adjunct to sutures in vascular surgery. Terminated |
NBE | None listed |