FDA Registration
Inactive
🇺🇸 United States
WELCH MEDICAL LLC
·
Expires 2025
Products
3
Proprietary Names
0
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- WELCH MEDICAL LLC
- Status
- Inactive
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 7950 NW 53rd Street, Suite 337
- City
- Miami
- State
- FL
- ZIP
- 33166
- Country
- US
Regulatory Submissions
- 510(k) Number
- K091918
Owner / Operator
- Firm Name
- Welch Medical LLC
- Operator Number
- 10093657
- Address
- 7950 NW 53rd Street, Suite 337
- City
- Miami
- State
- FL
- Postal Code
- 33166
- Country
- US
- Correspondent
- Fernando J Ramon
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | Class 2 | Radiology | No | 2025-06-22 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2025-06-22 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2025-06-22 |
Establishment Types
Repack or Relabel Medical Device
Manufacture Device in the United States for Export Only