FDA Registration
Active
🇺🇸 United States
TRIMEDYNE, INC.
Reg #: 1419951
·
FEI: 1419951
·
Expires 2026
Products
4
Proprietary Names
0
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- TRIMEDYNE, INC.
- Registration Number
- 1419951
- FEI Number
- 1419951
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 519 N. Smith Avenue, Suite 105
- City
- Corona
- State
- CA
- ZIP
- 92878
- Country
- US
Regulatory Submissions
- 510(k) Number
- K992574
Owner / Operator
- Firm Name
- TRIMEDYNE, INC.
- Operator Number
- 9920133
- Address
- 519 N. Smith Avenue, Suite 105
- City
- Corona
- State
- CA
- Postal Code
- 92878
- Country
- US
- Correspondent
- Na Luangchai
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2007-11-05 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2002-04-26 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2015-03-23 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2015-03-23 |
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility