FDA Registration
Active
🇺🇸 United States
NOVAMED-USA
Reg #: 2432320
·
FEI: 1000521377
·
Expires 2026
Products
5
Proprietary Names
0
Establishment Types
1
Classifications
5
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Registration Details
- Registration Name
- NOVAMED-USA
- Registration Number
- 2432320
- FEI Number
- 1000521377
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 4 WESTCHESTER PLZ STE 137
- City
- Elmsford
- State
- NY
- ZIP
- 10523
- Country
- US
Regulatory Submissions
- 510(k) Number
- K051419
Owner / Operator
- Firm Name
- NovaMedUSA, Inc
- Operator Number
- 10030147
- Address
- 4 Westchester Plaza
- City
- Elmsford
- State
- NY
- Postal Code
- 10523
- Country
- US
- Correspondent
- Peter M Derrico
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Thermal Regulating | DWJ | Class 2 | Cardiovascular | No | 2011-04-21 |
| Accessory Equipment, Cardiopulmonary Bypass | KRI | Class 1 | Cardiovascular | No | 2013-05-13 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2011-04-20 |
| Stethoscope, Esophageal, With Electrical Conductors | BZT | Class 2 | Anesthesiology | No | 2009-08-19 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2014-05-23 |
Establishment Types
Complaint File Establishment per 21 CFR 820.198