FDA Warning Letter — Envoy Medical Corporation

Case 718762 — FEI 3004007782

The FDA took a Warning Letter action against Envoy Medical Corporation on Nov 13, 2025 (Saint Paul, MN). The action was issued by CDRH and concerns devices products. This facility has 5 or more recent FDA inspections on record.

Action Details

Facility
Envoy Medical Corporation
Date
Nov 13, 2025
Fiscal Year
2026
Product Type
Devices
Center
CDRH
Location
Saint Paul, MN (United States)

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.