Data / Medical devices / United States / Mallinckrodt Hospital Products, Inc.
Mallinckrodt Hospital Products, Inc.: FDA-registered device maker in Hazelwood, MO, United States, 2 510(k) clearances
Mallinckrodt Hospital Products, Inc. is registered with the FDA (registration 3009140376) in Hazelwood, MO, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 14, 1985. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3009140376
- Address
- 675 McDonnell Blvd, Hazelwood, MO, United States, 63042
- Owner or operator
- Mallinckrodt Hospital Products, Inc (1925021)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 1, 1992
- Registered through
- 2026
- Brand names listed
- Recothrom, Shield, vial, Ultravent, Xenotron I Xenon (Xe 133) Gas Dispenser
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | Complaint file establishment | accessdata.fda.gov |
| Shield, Vial | IWW | 1 | Complaint file establishment | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Rebreathing, Radionuclide | IYT | 2 | Complaint file establishment | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 14, 1985 | K843640 | XENON XE 127/XE 133 GAS DISPENSER | IYT | Substantially Equivalent | Mallinckrodt Critical Care | accessdata.fda.gov |
| October 13, 1982 | K822625 | SYNTEVENT ATOMIZER/NEBULIZER AEROSOL | CCQ | Substantially Equivalent | Syva Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Shield, Vial
- All makers of Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
- All makers of System, Rebreathing, Radionuclide
- All makers of Tray, Surgical
- All makers of Syringe, Irrigating (Non Dental)
Updated January 14, 1985. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.