Data / Medical devices / United States / Guidemia Technologies, LLC
Guidemia Technologies, LLC: FDA-registered device maker in Buena Park, CA, United States, 2 510(k) clearances
Guidemia Technologies, LLC is registered with the FDA (registration 3013634985) in Buena Park, CA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 24, 2017. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3013634985
- Address
- 6532 University Way, Buena Park, CA, United States, 90620
- Owner or operator
- GuideMia Technologies, LLC (10042869)
- Roles
- Manufacturer
- First device listed
- January 8, 2013
- Registered through
- 2026
- Brand names listed
- GuideMia Implant Software, GuideMia OrthoPlus Software
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthodontic Software | PNN | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| March 24, 2017 | K162850 | GuideMia Ortho+ | PNN | Substantially Equivalent | Guidemia Technologies, LLC | accessdata.fda.gov |
| May 31, 2012 | K121466 | GUIDEMIA | LLZ | Substantially Equivalent | Guidemia Technologies, LLC | accessdata.fda.gov |
Compare with other makers
Updated March 24, 2017. 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.