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Sign in to claim this brandENVOY MEDICAL CORPORATION
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 4875 White Bear Pkwy, White Bear Lake, MN, 55110
- Website
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- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3004007782
- DUNS Number
- —
Catalogue (57)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Esteem® Laser Reflector | 1250 | FDA UDI | Class III | Active |
| Esteem® Intraoperative System Analyzer | 3001 | FDA UDI | Class III | Active |
| Esteem MedCem | 1610 | FDA UDI | Class III | Active |
| Esteem® Tapered Syringe Tips | 1725 | FDA UDI | Class III | Active |
| Esteem® Ear Insert Assembly | 1200 | FDA UDI | Class III | Active |
| Envoycem, Model 1640 | K080032 | FDA 510(k) | Class II | Active |
| Esteem | P090018 | FDA PMA | Class III | Active |
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FDA Recalls (2)
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 |
|---|---|---|---|---|
| Jun 28, 2018 | Z-2590-2018 | — | terminated | Sterile Wipes packed in these four Esteem II Sound Processors had an earlier expiration date than the final pack and the Esteem II Sound Processors. The Sterile Wipes expired prior to the date labeled on the final pack. |
| Jan 9, 2013 | Z-0750-2013 | — | terminated | Envoy Medical is conducting a voluntary correction of a limited number of Esteem Programmers, part of the Esteem Totally Implantable Hearing System, to reduce their susceptibility to noise interference. |