FDA Registration
Active
🇺🇸 United States
CURBELL MEDICAL PRODUCTS, INC.
Reg #: 1320360
·
FEI: 3000210521
·
Expires 2026
Products
6
Proprietary Names
18
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- CURBELL MEDICAL PRODUCTS, INC.
- Registration Number
- 1320360
- FEI Number
- 3000210521
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 20 Centre Dr
- City
- ORCHARD PARK
- State
- NY
- ZIP
- 14127
- Country
- US
Regulatory Submissions
- 510(k) Number
- K080605
Owner / Operator
- Firm Name
- CURBELL MEDICAL PRODUCTS, INC.
- Operator Number
- 9033808
- Address
- 20 CENTRE DR., --
- City
- Orchard Park
- State
- NY
- Postal Code
- 14127
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2008-08-08 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2024-04-19 |
| System, Communication, Powered | ILQ | Class 2 | Physical Medicine | No | 2006-12-07 |
| Monitor, Bed Patient | KMI | Class 1 | General Hospital | No | 1998-05-11 |
| Bed, Ac-Powered Adjustable Hospital | FNL | Class 2 | General Hospital | No | 2006-12-07 |
| System, Environmental Control, Powered | IQA | Class 2 | Physical Medicine | No | 2012-05-01 |
Proprietary Names
Clear Choice Lead Adapter
Clear Clip
Clear Tab/Snap Adapter
Sure-Lock Electrode Clip
Clear tab/DIN Adapter
Reusable Electrode Adapter
ECG Adapter Clip
Curbell Reuseable lead wires; OnePatient Disposable lead wires
Curbell Patient Monitoring Cables
Classic
Sealed
Click
BC201 Monitor
Safe Mobility Light
Rego Safe Mobility App
Curbell Reuseable lead wires, OnePatient Disposable lead wires
Curbell Bed Interconnect Cables
Bed Control
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device