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Sign in to claim this brandNova Medical Inc
United States·US-MF-000009719
Last updated September 17, 2026
Information
- Country
- United States
- Address
- Suite 201, 150 West Street, Wilmington, United States
- Website
- www.novamedical.com
- —
- —
- [email protected]
- Phone
- +1 978 988 5553
- PRRC Contact
- Cheryl Ledden
- EUDAMED SRN
- US-MF-000009719
- FDA FEI Number
- 3004531751
- DUNS Number
- 110821753
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 3T 32 CH Head Coil | 38320169 | FDA UDI | Class II | Active |
| 3T 32 Channel Head Coil | K182737 | FDA 510(k) | Class II | Active |
| Ariel Radio Frequency (rf) Electrosurgical Control Module And Accessories | K013730 | FDA 510(k) | Class II | Active |
| Electrosurgical Electrode Family, Model 20-2 Needle Balloon Catheter, Model 40-4 Needle Balloon Catheter, Model 60-6 Nee | K001150 | FDA 510(k) | Class II | Active |
| Electrosurgical Electrode Family | K001151 | FDA 510(k) | Class II | Active |
| Introducer Sheath | K001328 | FDA 510(k) | Class II | Active |
| Novasys Transurethral Rf System | K042132 | FDA 510(k) | Class II | Active |
| 8Tx32Rx 7T Head Coil Clinic | 8893279 | EUDAMEDFDA UDI | Class IIa | Active |
| 2Tx32Rx 7T Head Coil | 4318932 | EUDAMEDFDA UDI | Class IIa | Active |
| 1Tx32Rx 7T Head Coil Clinic | 1893279 | EUDAMEDFDA UDI | Class IIa | Active |
| 3T 32 CH Head Coil MR 750 | 3832016 | EUDAMEDFDA UDI | Class I | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 27, 2009 | Z-1404-2010 | — | terminated | Instructions for Use (IFU) revision-- Because of complaints received by the firm of worsened stress incontinence symptoms 3-4 weeks after treatment, the instructions for use were revised to emphasize potential side effects. Although Novasys has not, to date, identified a device malfunction associated with the symptoms discussed above, the investigation over time shows that there is a correlation |