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Sign in to claim this brandGENESEE BIOMEDICAL, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 700 W Mississippi Ave Unit D5, DENVER, CO, 80223
- Website
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1000517719
- DUNS Number
- —
Catalogue (152)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800sr | K072655 | FDA 510(k) | Class II | Active |
| NeoForm Annuloplasty Ring | K190506 | FDA 510(k) | Class II | Active |
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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 |
|---|---|---|---|---|
| Feb 26, 2018 | Z-1953-2018 | — | open, classified | Failure in a retractor blade due to corrosion. In the area of the blade where the bearing/button meets the blade body, corrosion can form, weakening the welded joint and may cause the bearing/button to break. |