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Envoy Medical Corporation: FDA-registered device maker in White Bear Lake, MN, United States, 1 510(k) clearance and 1 PMA approval

Name: Envoy Medical Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Envoy Medical Corporation is registered with the FDA (registration 3004007782) in White Bear Lake, MN, United States. It lists 2 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated March 17, 2010. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Envoy Medical Corporation

FDA registration number: 3004007782
Address: 4875 White Bear Pkwy, White Bear Lake, MN, United States, 55110
Owner or operator: ENVOY MEDICAL CORPORATION (9092560)
Roles: Manufacturer
First device listed: March 3, 2008
Registered through: 2027
Brand names listed: EnvoyCem, Esteem

Devices it lists

Device	Product code	Class	Role	Source
Cement, Ear, Nose And Throat	NEA	2	Manufacturer	accessdata.fda.gov
Implant, Hearing, Active, Middle Ear, Totally Implanted	OAF	3	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 28, 2008	K080032	ENVOYCEM, MODEL 1640	NEA	Substantially Equivalent	Envoy Medical Corporation	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
March 17, 2010	P090018	ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM	OAF	40	October 15, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 28, 2018	80489	Class II	Terminated	Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018). An Implantable Middle Ear Hearing Device.	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.	accessdata.fda.gov
January 9, 2013	63875	Class II	Terminated	Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implantable Hearing System. The ISA and Commander are software packages that run on a laptop personal computer.	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.	accessdata.fda.gov

Compare with other makers

All makers of Cement, Ear, Nose And Throat

Updated October 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.