FDA Registration
Active
🇺🇸 United States
STEREOTAXIS, INC.
Reg #: 3003084417
·
FEI: 3003084417
·
Expires 2026
Products
7
Proprietary Names
8
Establishment Types
3
Classifications
7
Registration Details
- Registration Name
- STEREOTAXIS, INC.
- Registration Number
- 3003084417
- FEI Number
- 3003084417
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 710 N. Tucker Blvd., Suite 110
- City
- Saint Louis
- State
- MO
- ZIP
- 63101
- Country
- US
Regulatory Submissions
- 510(k) Number
- K093092
- PMA Number
- P240014
Owner / Operator
- Firm Name
- Stereotaxis
- Operator Number
- 9048165
- Address
- 710 N. Tucker Blvd., Suite 110
- City
- Saint Louis
- State
- MO
- Postal Code
- 63101
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2018-12-14 |
| Catheter Remote Control System | PJB | Class 2 | Cardiovascular | No | 2023-05-17 |
| System, Catheter Or Guidewire, Steerable (Magnetic) | NDQ | Class 2 | Cardiovascular | No | 2023-05-17 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2011-06-09 |
| System, Catheter Control, Steerable | DXX | Class 2 | Cardiovascular | No | 2016-01-11 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2016-01-11 |
| Cardiac Ablation Percutaneous Catheter | LPB | Class 3 | Unknown | No | 2026-01-08 |
Proprietary Names
Odyssey Workstation
Niobe Magnetic Navigation System
SynX
Odyssey Cinema, Link, Enterprise, Interface and Studio
Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System (Genesis MNS)
MAGiC Ablation Catheter
Stereotaxis GenesisX RMN with Navigant Workstation (NWS)
Cardiodrive Catheter Advancement Sy
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198