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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 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| INOmax | 91343 | FDA UDI | Class I | Active |
| INOblender | 10004 | FDA UDI | Class II | Active |
| INOmax | 10041 | FDA UDI | Class II | Active |
| INOmax | 50417 | FDA UDI | Class I | Active |
| INOmax | 90855 | FDA UDI | Class II | Active |
| INOmax | 91349 | FDA UDI | Class I | Active |
| INOmax | 50280 | FDA UDI | Class II | Active |
| INOmax | 10090 | FDA UDI | Class II | Active |
| INOmax DSIR Plus MRI | 10074 | FDA UDI | Class II | Active |
| INOmax | 91350 | FDA UDI | Class I | Active |
| INOmax | 90845 | FDA UDI | Class II | Active |
| INOmax | 10072 | FDA UDI | Class II | Active |
| INOmax | 81091 | FDA UDI | Class I | Active |
| INOmax | 91348 | FDA UDI | Class I | Active |
| INOcal | BOM-COM-0167 | FDA UDI | Class I | Active |
| INOmax | 50428 | FDA UDI | Class I | Active |
| INOmax | 10070 | FDA UDI | Class II | Active |
| INOmax | 50415 | FDA UDI | Class I | Active |
| INOmax | 91346 | FDA UDI | Class I | Active |
| INOmax | 81086 | FDA UDI | Class I | Active |
| INOmax | 81098 | FDA UDI | Class I | Active |
| INOmax | 50383 | FDA UDI | Class I | Active |
| INOmax | 50370 | FDA UDI | Class II | Active |
| INOmax | 90844 | FDA UDI | Class II | Active |
| INOmax | 91424 | FDA UDI | Class I | Active |
| INOmax | 10014 | FDA UDI | Class I | Active |
| INOmax | 10031 | FDA UDI | Class II | Active |
| INOmax | 91347 | FDA UDI | Class I | Active |
| INOmax | 10006 | FDA UDI | Class II | Active |
| INOmax | 91270 | FDA UDI | Class II | Active |
| INOmax | 50371 | FDA UDI | Class II | Active |
| INOmax | 81097 | FDA UDI | Class I | Active |
| INOmax | 91426 | FDA UDI | Class I | Active |
| INOmax | 10022 | FDA UDI | Class II | Active |
| INOcal | BOM-COM-0159 | FDA UDI | Class I | Active |
| INOmax | 91344 | FDA UDI | Class I | Active |
| INOmax | 50239 | FDA UDI | Class II | Active |
| INOmax | 81126 | FDA UDI | Class I | Active |
| INOmax | 50402 | FDA UDI | Class I | Active |
| INOmax | 81124 | FDA UDI | Class I | Active |
| INOmax | 91359 | FDA UDI | Class II | Active |
| INOmax | 81095 | FDA UDI | Class I | Active |
| INOmax | 81094 | FDA UDI | Class I | Active |
| INOmax | 50372 | FDA UDI | Class II | Active |
| INOblender MRI | 10077 | FDA UDI | Class II | Active |
| INOmax | 81096 | FDA UDI | Class I | Active |
| INOmax | 10095 | FDA UDI | Class II | Active |
| INOmax | 81124 | FDA UDI | Class I | Active |
| INOmax | 91352 | FDA UDI | Class I | Active |
| INOmax | 91345 | FDA UDI | Class I | 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. |