FDA Registration
Active
🇺🇸 United States
MEDICAL OUTFITTERS, INC
Reg #: 3009154005
·
FEI: 3009154005
·
Expires 2026
Products
5
Proprietary Names
6
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- MEDICAL OUTFITTERS, INC
- Registration Number
- 3009154005
- FEI Number
- 3009154005
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 8062 NW 66th St
- City
- Miami
- State
- FL
- ZIP
- 33166
- Country
- US
Regulatory Submissions
- 510(k) Number
- K160743
Owner / Operator
- Firm Name
- Medical Outfitters, Inc
- Operator Number
- 10044808
- Address
- 8062 NW 66 Street
- City
- Miami
- State
- FL
- Postal Code
- 33166
- Country
- US
- Correspondent
- Miguel A Machuca
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2025-07-31 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2018-10-23 |
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2021-03-09 |
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | Class 2 | Radiology | No | 2021-03-09 |
| X-Ray, Computed Tomography, Cone-Beam | SFV | Class 2 | Radiology | No | 2026-04-20 |
Proprietary Names
nasal Biliary drainage tube
Hot Forceps
Cytology brush
Philips Brilliance 64
Planmed XFI
GE Signa Excite HDxt HD 23 1.5T
Establishment Types
Repack or Relabel Medical Device
Reprocess Single-Use Device