FDA Registration
Active
🇺🇸 United States
VISIONARE LLC
Reg #: 3011196443
·
FEI: 3011196443
·
Expires 2026
Products
14
Proprietary Names
2
Establishment Types
3
Classifications
14
Registration Details
- Registration Name
- VISIONARE LLC
- Registration Number
- 3011196443
- FEI Number
- 3011196443
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 12220 ITEC Haul Dr, Units 215/216
- City
- Fort Myers
- State
- FL
- ZIP
- 33913
- Country
- US
Regulatory Submissions
- 510(k) Number
- K180204
Owner / Operator
- Firm Name
- Visionare LLC
- Operator Number
- 10047752
- Address
- 12220 ITEC Haul Dr, Units 215/216
- City
- Fort Myers
- State
- FL
- Postal Code
- 33913
- Country
- US
- Correspondent
- Pedro H Oliveira de Carvalho
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2018-12-03 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2018-12-03 |
| Template | HWT | Class 1 | Orthopedic | No | 2018-12-03 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2018-12-03 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2018-12-03 |
| Screw, Fixation, Intraosseous | DZL | Class 2 | Dental | No | 2019-01-08 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2019-01-08 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2018-12-03 |
| Trocar, Ent | KTE | Class 1 | Ear, Nose, Throat | No | 2018-12-03 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2018-12-03 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2018-12-03 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2018-12-03 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2018-12-03 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2018-12-03 |
Proprietary Names
Visionare
VISIONARE
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device