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Sign in to claim this brandKoios Medical, Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 242 West 38th Street, New York, NY, 10018
- Website
- koiosmedical.com
- —
- —
- [email protected]
- Phone
- 7325295755
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3010119782
- DUNS Number
- 093725663
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Koios Medical | 2.x | FDA UDI | Class II | Active |
| Koios DS | 3.x | FDA UDI | Class II | Active |
| Koios DS | K242130 | FDA 510(k) | Class II | Active |
| Koios DS for Breast | K190442 | FDA 510(k) | Class II | Active |
| Koios DS | K212616 | FDA 510(k) | Class II | Active |
Related Companies
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No authorised representatives on record.
Importers
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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 |
|---|---|---|---|---|
| Dec 31, 2019 | Z-0820-2020 | — | terminated | Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedures. |