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Sign in to claim this brandNuMED, Inc.
United States·US-MF-000010948
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 2880, Main Street, Hopkinton, United States
- Website
- numedusa.com
- —
- —
- [email protected]
- Phone
- 1-315-328-4491
- PRRC Contact
- Nichelle LaFlesh
- EUDAMED SRN
- US-MF-000010948
- FDA FEI Number
- 1318694
- DUNS Number
- 114186877
Catalogue (511)
Page 1 of 11| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| Sf-Nih | 317 | FDA UDI | Class II | Unknown |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| Tearduct Catheter | 352 | FDA UDI | Class I | Unknown |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| Sf-Nih | 317 | FDA UDI | Class II | Unknown |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
| REBOA Catheter | 362 | FDA UDI | Class II | Active |
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FDA Recalls (5)
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 |
|---|---|---|---|---|
| Apr 21, 2025 | Z-1754-2025 | — | terminated | Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon. |
| Oct 17, 2018 | Z-0510-2019 | — | terminated | Instructions for Use booklets were not included on the outer pouch |
| Oct 17, 2018 | Z-0511-2019 | — | terminated | Instructions for Use booklets were not included on the outer pouch |
| Sep 23, 2009 | Z-0509-2010 | — | terminated | The firm received a complaint from the sole direct account that while performing an inventory review it was observed that the packaging of the IMPACT catheter was cracked and deteriorating. The product was still in its packaging and never used. The customer referred to it as looking like "paint crackle." The risk is that for continued sterility to be assured, the packaging must remain intact. |
| Jun 26, 2003 | Z-0983-03 | — | terminated | Lacks a PMA or 510k. |