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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 3 of 11| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Numed Z-5 Atrioseptostomy Catheter | K001804 | FDA 510(k) | Class II | Active |
| REBOA Balloon Catheter | K160598 | FDA 510(k) | Class II | Active |
| Modified Numed Balloon Angiographic Catheter | K883948 | FDA 510(k) | Class II | Active |
| Mullins-X Ptv Catheter | K102473 | FDA 510(k) | Class II | Active |
| Pts-X Sizing Balloon Catheter | K131869 | FDA 510(k) | Class II | Active |
| Numed Balloon Pacing Catheter | K851246 | FDA 510(k) | Class II | Active |
| Numed High Pressure Pta Catheters | K010880 | FDA 510(k) | Class II | Active |
| D'Vill Introducer | K171206 | FDA 510(k) | Class II | Active |
| BIB Stent Placement Catheter | K211134 | FDA 510(k) | Class II | Active |
| Numed Ghost Ii Pta Catheters | K003972 | FDA 510(k) | Class II | Active |
| Intravascular Catheter W/Doppler Transducer | K860121 | FDA 510(k) | Class II | Active |
| BIB Stent Placement Catheter | K161451 | FDA 510(k) | Class II | Active |
| Numed Balloon Thermodilution Catheter | K881893 | FDA 510(k) | Class II | Active |
| Numed Temp. Stylet Pacing Parobe 1318694 | K851845 | FDA 510(k) | Class II | Active |
| Tyshak Mini Pediatric Ptv Catheter, Model 107 | K003276 | FDA 510(k) | Class II | Active |
| Pta, Ptv, Atrioseptostomy, Angiographic, Sizing Catheters | K040830 | FDA 510(k) | Class II | Active |
| Numed Balloon Pacing Catheter | K843290 | FDA 510(k) | Class II | Active |
| Numed Balloon Wedge Pressure Catheter | K864943 | FDA 510(k) | Class II | Active |
| Pta And Ptv | K022722 | FDA 510(k) | Class II | Active |
| Mini Ghost Pta Catheter, Model 507 | K051343 | FDA 510(k) | Class II | Active |
| Tyshak Peripheral Balloon Dilation Catheter | K931009 | FDA 510(k) | Class II | Active |
| Numed Pta Catheters | K871796 | FDA 510(k) | Class II | Active |
| Pts-X Sizing Balloon Catheter | K110903 | FDA 510(k) | Class II | Active |
| Multitrack Angiographic Catheter | K003902 | FDA 510(k) | Class II | Active |
| Z-6 Atrioseptostomy Catheter | K211910 | FDA 510(k) | Class II | Active |
| Numed Balloon Angiographic Catheters | K864940 | FDA 510(k) | Class II | Active |
| Mini Ghost, Model: 507 | K082524 | FDA 510(k) | Class II | Active |
| Mullins-X, Model 250x | K082868 | FDA 510(k) | Class II | Active |
| Pta-Os Sizing Balloon, Model 360 | K003320 | FDA 510(k) | Class II | Active |
| Nucleus-X, Model 230x | K081680 | FDA 510(k) | Class II | Active |
| Bib Pta Balloon Catheter | K050857 | FDA 510(k) | Class II | Active |
| Numed Atrioseptostomy Catheter | K960070 | FDA 510(k) | Class II | Active |
| D'Vill Introducer | K190974 | FDA 510(k) | Class II | Active |
| COEfficient | COE141 | EUDAMED | Class III | Active |
| Tyshak | PDC039 | EUDAMED | Class III | Active |
| Tyshak | SO012 | EUDAMED | Class III | Active |
| Z-Med-X | PDZ414 | EUDAMED | Class III | Active |
| Mullins-X | PTM450 | EUDAMED | Class III | Active |
| COEfficient | COE151 | EUDAMED | Class III | Active |
| Z-Med | PDZ326 | EUDAMED | Class III | Active |
| Mullins-X | PTM454 | EUDAMED | Class III | Active |
| Z-Med | SN023 | EUDAMED | Class III | Active |
| Z-Med | PDZ324 | EUDAMED | Class III | Active |
| Z-Med Ii | PDZ663 | EUDAMED | Class III | Active |
| Tyshak-X | PDC321 | EUDAMED | Class III | Active |
| Bib | BB023 | EUDAMED | Class III | Active |
| Tyshak | PDC147 | EUDAMED | Class III | Active |
| Z-Med | PDZ366 | EUDAMED | Class III | Active |
| Z-Med-X | PDZ425 | EUDAMED | Class III | Active |
| Z-Med-X | PDZ430 | EUDAMED | Class III | 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. |