FDA Registration
Active
🇺🇸 United States
CORK MEDICAL, LLC
Reg #: 3010588638
·
FEI: 3010588638
·
Expires 2026
Products
3
Proprietary Names
6
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- CORK MEDICAL, LLC
- Registration Number
- 3010588638
- FEI Number
- 3010588638
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8000 Castleway Drive
- City
- Indianapolis
- State
- IN
- ZIP
- 46250
- Country
- US
Regulatory Submissions
- 510(k) Number
- K140022
Owner / Operator
- Firm Name
- Cork Medical Products, LLC
- Operator Number
- 10046132
- Address
- 8000 Castleway Drive
- City
- Indianapolis
- State
- IN
- Postal Code
- 46250
- Country
- US
- Correspondent
- Patrick McGinley
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | Class 2 | General, Plastic Surgery | No | 2015-03-09 |
| Cushion, Flotation | KIC | Class 1 | Physical Medicine | No | 2015-01-12 |
| Mattress, Air Flotation, Alternating Pressure | FNM | Class 2 | General Hospital | No | 2014-02-06 |
Proprietary Names
Nisus
VERSA Negative Pressure Wound Therapy System
Cork Medical, LLC
Forever Cushion
Elite Balance Air
Nisus ONE Negative Pressure Wound Therapy System
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device