Data / Medical devices / United States / Hospitec USA
Hospitec USA: FDA-registered device maker in Fort Smith, AR, United States, 1 510(k) clearance
Hospitec USA is registered with the FDA (registration 3008009298) in Fort Smith, AR, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 18, 1996. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008009298
- Address
- 3730 Wheeler Ave, Fort Smith, AR, United States, 72901
- Owner or operator
- Hospitec USA (10030442)
- Roles
- Specification developer
- First device listed
- October 5, 2009
- Registered through
- 2026
- Brand names listed
- Medi Bulter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | 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 18, 1996 | K954500 | HOSPITEC MEDI-BUTLER | FMI | Substantially Equivalent | Hospitec, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 18, 1996. 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.