510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Envoy Medical Corporation

White Bear Lake, MN, US

ENVOY MEDICAL CORPORATION appears in FDA device records in White Bear Lake, MN. FDA records list one 510(k) clearance, 40 PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
40
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Envoy Medical Corporation in 2008.

Clearances by year, as a table
510(k) clearance decisions for Envoy Medical Corporation, by decision year
YearClearances
20081
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K080032ENVOYCEM, MODEL 1640NEASubstantially Equivalent

Registered establishments

FDA registered establishments for Envoy Medical Corporation, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30040077823004007782ENVOY MEDICAL CORPORATION4875 White Bear Pkwy, White Bear Lake, MN 55110 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2590-2018Final 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.Class IITerminated
Z-0750-2013Esteem 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.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain