Data / Medical devices / United States / Tyro Medical, LLC
Tyro Medical, LLC: FDA-registered device maker in Ridgefield, CT, United States, 1 510(k) clearance
Tyro Medical, LLC is registered with the FDA (registration 3027588012) in Ridgefield, CT, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 25, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027588012
- Address
- 14 Rochambeau Avenue, Ridgefield, CT, United States, 06877
- Owner or operator
- Tyro Medical, LLC (10088272)
- Roles
- Complaint file establishment
- First device listed
- June 29, 2023
- Registered through
- 2026
- Brand names listed
- BC1001S, BC1001U, BC4508S, BC4508U, BC7008S, BC7008U, Contact AN Evo, Contact Forte and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Irrigation | GBX | 1 | Complaint file establishment | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Complaint file establishment | accessdata.fda.gov |
| Hearing Aid, Bone Conduction | LXB | 2 | Complaint file establishment | accessdata.fda.gov |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | 1 | 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 |
|---|---|---|---|---|---|---|
| April 25, 2025 | K243041 | contact forte Alpha | LXB | Substantially Equivalent | Bhm-Tech Produktionsgesellschaft Mbh | accessdata.fda.gov |
Compare with other makers
- All makers of Surgical Instruments, G-U, Manual (And Accessories)
- All makers of Drape, Surgical, Exempt
- All makers of Hearing Aid, Bone Conduction
- All makers of Catheter, Irrigation
Updated April 25, 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.