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Sign in to claim this brandMyelotec, Inc.
US
Last updated May 30, 2026
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 006731844
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Video Guided Catheter | 2010 | FDA UDI | Class II | Active |
| Epiduroscopy Introducer Set | 4008 | FDA UDI | Class II | Active |
| Video Guided Catheter | 2033 | FDA UDI | Class II | Active |
| Epiduroscopy Introducer Set | 4007 | FDA UDI | Class II | Active |
| NaviCath | 2017 | FDA UDI | Class II | Active |
| Myelotec Video Guided Catheter | K980734 | FDA 510(k) | Class II | Active |
| J-Scope System | K122411 | FDA 510(k) | Class II | Active |
| Myelotec Myeloscope | K960194 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (3)
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 |
|---|---|---|---|---|
| Mar 2, 2017 | Z-2779-2017 | — | open, classified | Obstructed/blocked port from defective VGC Access Port Body component. |
| Dec 19, 2007 | Z-0587-2008 | — | terminated | Incorrect Labeling information: Product may contain inappropriate information in its label insert that refers to the product's use with energy delivering instrumentation. |
| Dec 19, 2007 | Z-0586-2008 | — | terminated | Incorrect Labeling information: Product may contain inappropriate information in its label insert that refers to the product's use with energy delivering instrumentation. |