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Sign in to claim this brandREFLOW MEDICAL, INC.
United States·US-MF-000017521
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 208, Avenida Fabricante, San Clemente, United States
- Website
- reflowmedical.com
- —
- —
- [email protected]
- Phone
- 9494810399
- PRRC Contact
- Angela Lamprey
- EUDAMED SRN
- US-MF-000017521
- FDA FEI Number
- 3027058844
- DUNS Number
- 962545294
Catalogue (81)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Spex LP | SLP18150US | FDA UDI | Class II | Active |
| coraFlex | FLX14150US | FDA UDI | Class II | Active |
| Spex18 | SPX18135US | FDA UDI | Class II | Active |
| Wingman18 | WGM18135US | FDA UDI | Class II | Active |
| Wingman35 | WGM35090US | FDA UDI | Class II | Active |
| Spex35 | SPX35090US | FDA UDI | Class II | Active |
| Wingman18 | WGM18150US | FDA UDI | Class II | Active |
| Wingman35 | WGM35135US | FDA UDI | Class II | Active |
| Spex35 | SPX35050US | FDA UDI | Class II | Active |
| Spex35 | SPX35150US | FDA UDI | Class II | Active |
| Wingman18c | WMC18135US | FDA UDI | Class II | Active |
| Spex35 | SPX35135US | FDA UDI | Class II | Active |
| Spex LP | SLP35090US | FDA UDI | Class II | Active |
| Spex LP | SLP14135US | FDA UDI | Class II | Active |
| coraForce | FRC14135US | FDA UDI | Class II | Active |
| Spur Peripheral Retrievable Stent System | BSPUR460135US | FDA UDI | Class II | Active |
| Wingman14c | WMC14090US | FDA UDI | Class II | Active |
| Spex LP | SLP35135US | FDA UDI | Class II | Active |
| Spex14 | SPX14135US | FDA UDI | Class II | Active |
| Spex LP | SLP18090US | FDA UDI | Class II | Active |
| Wingman14 | WGM14150US | FDA UDI | Class II | Active |
| Spex LP | SLP18135US | FDA UDI | Class II | Active |
| Wingman35 | WGM35065US | FDA UDI | Class II | Active |
| Wingman14c | WMC14150US | FDA UDI | Class II | Active |
| Spur Peripheral Retrievable Stent System | BSPUR365135US | FDA UDI | Class II | Active |
| Spex18 | SPX18090US | FDA UDI | Class II | Active |
| Spex35 | SPN35050US | FDA UDI | Class II | Active |
| Spex14 | SPX14090US | FDA UDI | Class II | Active |
| Spex35 | SPN35135US | FDA UDI | Class II | Active |
| coraForce | FRC14150US | FDA UDI | Class II | Active |
| Wingman18c | WMC18150US | FDA UDI | Class II | Active |
| Spex18 | SPX18150US | FDA UDI | Class II | Active |
| Spex LP | SLP14090US | FDA UDI | Class II | Active |
| Spex14 | SPX14150US | FDA UDI | Class II | Active |
| coraCross | CRX14150US | FDA UDI | Class II | Active |
| Spex LP | SLP35150US | FDA UDI | Class II | Active |
| Spex LP | SLP14150US | FDA UDI | Class II | Active |
| Sinc | SINC35135US | FDA UDI | Class II | Active |
| Wingman18c | WMC18090US | FDA UDI | Class II | Active |
| coraFlex | FLX14135US | FDA UDI | Class II | Active |
| Wingman14 | WGM14135US | FDA UDI | Class II | Active |
| Sinc | SINC35090US | FDA UDI | Class II | Active |
| Wingman14 | WGM14065US | FDA UDI | Class II | Active |
| Wingman18 | WGM18090US | FDA UDI | Class II | Active |
| Wingman14c | WMC14135US | FDA UDI | Class II | Active |
| Spex35 | SPN35150US | FDA UDI | Class II | Active |
| Spex35 | SPN35090US | FDA UDI | Class II | Active |
| coraCross | K210188 | FDA 510(k)FDA UDI | Class II | Active |
| Wingman 14, Wingman 14C, Wingman 18, Wingman 35 | K193596 | FDA 510(k) | Class II | Active |
| Wingman Extendable Tip Support Catheter | K120178 | FDA 510(k) | Class II | Active |
Related Companies
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Importers
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Notified Bodies
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Authorities
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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 |
|---|---|---|---|---|
| Mar 22, 2017 | Z-1898-2017 | — | terminated | ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detachment. |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Reflow Medical, Inc San Clemente, CA · US FEI 3008789872