Data / Medical devices / United States / Caranx, Inc.
Caranx, Inc.: FDA-registered device maker in Claymont, DE, United States, 1 510(k) clearance
Caranx, Inc. is registered with the FDA (registration 3047842058) in Claymont, DE, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 7, 2025. 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
- 3047842058
- Address
- 2093 Philadelphia Pike Pmb 3795, Claymont, DE, United States, 19703
- Owner or operator
- Caranx, Inc. (10096170)
- Roles
- Complaint file establishment
- First device listed
- July 15, 2026
- Registered through
- 2026
- Brand names listed
- TAVIPILOT Software
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment | accessdata.fda.gov |
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| July 7, 2025 | K243884 | TAVIPILOT | OWB | Substantially Equivalent | Caranx Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Interventional Fluoroscopic X-Ray System
- All makers of Automated Radiological Image Processing Software
Updated July 7, 2025. 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.