Data / Medical devices / United States / Smithworks, Inc.
Smithworks, Inc.: FDA-registered device maker in Lindale, TX, United States, 1 510(k) clearance
Smithworks, Inc. is registered with the FDA (registration 3005730406) in Lindale, TX, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 22, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005730406
- Address
- 13626 FM 2710, Lindale, TX, United States, 75771
- Owner or operator
- Smithworks, Inc. (10053160)
- Roles
- Manufacturer, Remanufacturer
- First device listed
- November 4, 2016
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Warmer, Thermal, Infusion Fluid | LGZ | 2 | Manufacturer, Remanufacturer | 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 |
|---|---|---|---|---|---|---|
| December 22, 2006 | K060851 | SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV WARMER AND THE THERMAL SAC PRESSURE INFUSER | LGZ | Substantially Equivalent | The Smithworks Company | accessdata.fda.gov |
Compare with other makers
Updated December 22, 2006. 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.