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ENVOY MEDICAL CORPORATION

Last updated September 17, 2026

Information

Country: US
Address: 4875 White Bear Pkwy, White Bear Lake, MN, 55110
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3004007782
DUNS Number: —

Catalogue (57)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Esteem® Glasscock Stabilizers	1730	FDA UDI	Class III	Active
Esteem® Driver Replica	1510	FDA UDI	Class III	Active
EnvoyCem®	1640	FDA UDI	Class II	Active
Esteem® Intraoperative System Analyzer	3001	FDA UDI	Class III	Active
Esteem® Intraoperative System Analyzer	3001	FDA UDI	Class III	Active
Esteem Intraoperative System Analyzer	3200	FDA UDI	Class III	Active
Esteem® Personal Programmer	8001	FDA UDI	Class III	Active
Esteem® Sterile Drape	1300	FDA UDI	Class III	Active
Esteem® Bone Screws	1790	FDA UDI	Class III	Active
Esteem® MedCem®	1610	FDA UDI	Class III	Active
Esteem® Intraoperative System Analyzer	3001	FDA UDI	Class III	Active
Esteem® Sensor Replica	1510	FDA UDI	Class III	Active
Esteem® Intraoperative System Analyzer	3001	FDA UDI	Class III	Active
Esteem® Laser Light Guide	1720	FDA UDI	Class III	Active
Esteem® Syringe	1710	FDA UDI	Class III	Active
Esteem® IS-1 Lead End Cap	1400	FDA UDI	Class III	Active
Esteem® Sensor	7010	FDA UDI	Class III	Active
Esteem® Driver Replica	1510	FDA UDI	Class III	Active
Esteem® Intraoperative System Analyzer	3001	FDA UDI	Class III	Active
Esteem® Driver	7510	FDA UDI	Class III	Active
Esteem® MedCem®	1610	FDA UDI	Class III	Active
Esteem® Laser Light Guide	1720	FDA UDI	Class III	Active
Esteem® EnvoyCem®	1640	FDA UDI	Class III	Active
Esteem® Driver	7504	FDA UDI	Class III	Active
Esteem® Surgical Tools Kit	1216	FDA UDI	Class III	Active
Esteem® Ear Insert Assembly	1200	FDA UDI	Class III	Active
Esteem® Sensor Replica	1510	FDA UDI	Class III	Active
Esteem® Intraoperative System Analyzer	3001	FDA UDI	Class III	Active
Esteem® Intraoperative System Analyzer	3001	FDA UDI	Class III	Active
Esteem® Sensor	7004	FDA UDI	Class III	Active
Esteem® Intraoperative System Analyzer	3001	FDA UDI	Class III	Active
Esteem® MedCem®	1610	FDA UDI	Class III	Active
Esteem® Ear Insert Assembly	1200	FDA UDI	Class III	Active
Esteem® Intraoperative System Analyzer	3001	FDA UDI	Class III	Active
Esteem® Transducer Replica	1510	FDA UDI	Class III	Active
Esteem® Commander™	6001	FDA UDI	Class III	Active
Esteem® Commander™	6002	FDA UDI	Class III	Active
Esteem® MedCem®	1610	FDA UDI	Class III	Active
Esteem® Subdural Needle Electrode	1740	FDA UDI	Class III	Active
Esteem® Commander™	6002	FDA UDI	Class III	Active
Esteem® Commander™	6001	FDA UDI	Class III	Active
Esteem® Transducer Replica	1510	FDA UDI	Class III	Active
Esteem® Sound Processor Replica	1500	FDA UDI	Class III	Active
Esteem® Sound Processor	2001	FDA UDI	Class III	Active
Esteem® Intraoperative System Analyzer	3001	FDA UDI	Class III	Active
Esteem® Bone Screws	1790	FDA UDI	Class III	Active
Esteem® Intraoperative System Analyzer	3001	FDA UDI	Class III	Active
Esteem® Sensor	7004	FDA UDI	Class III	Active
Esteem® Sound Processor	2001	FDA UDI	Class III	Active
Esteem® Driver	7504	FDA UDI	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.