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Sign in to claim this brandMallinckrodt Manufacturing, LLC
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 6603 Femrite Dr, MADISON, WI, 53718
- Website
- mnk.com
- —
- —
- [email protected]
- Phone
- +1(877)566-9466
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3004531588
- DUNS Number
- 828331780
Catalogue (72)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| INOmax | 10021 | FDA UDI | Class II | Active |
| INOmax | 81125 | FDA UDI | Class I | Active |
| INOmax | 81093 | FDA UDI | Class I | Active |
| INOmax DSIR Plus | 10007 | FDA UDI | Class II | Active |
| INOmax | 91353 | FDA UDI | Class I | Active |
| INOmax | 10071 | FDA UDI | Class II | Active |
| INOmax | 91425 | FDA UDI | Class I | Active |
| INOmax | 81090 | FDA UDI | Class I | Active |
| INOmax | 81088 | FDA UDI | Class I | Active |
| INOmax | 10020 | FDA UDI | Class II | Active |
| INOmax | 81087 | FDA UDI | Class I | Active |
| INOmax | 50312 | FDA UDI | Class II | Active |
| INOmax | 91351 | FDA UDI | Class II | Active |
| INOmax | 81092 | FDA UDI | Class I | Active |
| INOmax | 50403 | FDA UDI | Class I | Active |
| INOmax | 50387 | FDA UDI | Class I | Active |
| INOmax | 10107 | FDA UDI | Class II | Active |
| EVOLVE Nitric Oxide Delivery System | K242578 | FDA 510(k) | Class II | Active |
| EVOLVE Nitric Oxide Delivery System | K240410 | FDA 510(k) | Class II | Active |
| Evolve Nitric Oxide Delivery System | K222930 | FDA 510(k) | Class II | Active |
| Inomax DSIR | K211153 | FDA 510(k) | Class II | Active |
| INOmax DSIR Plus | K200389 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Aug 8, 2023 | Z-2450-2023 | — | open, classified | The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen. |
| Oct 17, 2014 | Z-2687-2017 | — | terminated | Product was improperly labeled leading to improper storage. |