Envoy Medical Corporation

Form 483FOIA Uncovered

Saint Paul, Minnesota, United StatesFEI 3004007782Issued July 02, 2025

View FDA's Record for This Firm

Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3004007782.

Observations6

Issue DateJuly 02, 2025

Status1 Related Warning Letter

Related Inspections8

Establishment Details

Firm: Envoy Medical Corporation
Location: Saint Paul, Minnesota, United States
FEI Number: 3004007782
Product Type: Devices
Issue Date: July 02, 2025
Country: United States

Inspection History, 2009 to 2025

NAI4

VAI3

OAI1

NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.

Act on This Form 483

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Envoy Medical Corporation FDA Form 483, Saint Paul, Minnesota, July 2, 2025