Data / Medical devices / United States / Solventum US LLC
Solventum US LLC: FDA-registered device maker in Eden Prairie, MN, United States, 4 510(k) clearances
Solventum US LLC is registered with the FDA (registration 3036108847) in Eden Prairie, MN, United States. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 30, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3036108847
- Address
- 10351 West 70th Street, Eden Prairie, MN, United States, 55344
- Owner or operator
- Solventum US LLC (10091183)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- January 17, 2013
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Infusor, Pressure, For I.V. Bags | KZD | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| System, Thermal Regulating | DWJ | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Warmer, Blood, Non-Electromagnetic Radiation | BSB | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Warmer, Thermal, Infusion Fluid | LGZ | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| May 30, 2012 | K120412 | 3M SPOTON TEMPERATURE MONITORING SYSTEM | FLL | Substantially Equivalent | Arizant Healthcare, Inc. | accessdata.fda.gov |
| June 26, 2006 | K060939 | RANGER IRRIGATION FLUID WARMING SYSTEM | LGZ | Substantially Equivalent | Arizant Healthcare, Inc. | accessdata.fda.gov |
| April 24, 2006 | K060865 | BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850 | DWJ | Substantially Equivalent | Arizant Healthcare, Inc. | accessdata.fda.gov |
| April 30, 1998 | K973741 | BAIR HUGGER BLOOD/FLUID WARMER | BSB | Substantially Equivalent | Augustine Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Warmer, Blood, Non-Electromagnetic Radiation
- All makers of System, Thermal Regulating
- All makers of Warmer, Thermal, Infusion Fluid
- All makers of Continuous Measurement Thermometer
- All makers of Infusor, Pressure, For I.V. Bags
Updated May 30, 2012. 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.