FDA Warning Letter — Envoy Medical Corporation

Case 718762 — FEI 3004007782

The FDA took a Warning Letter action against Envoy Medical Corporation on November 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
November 13, 2025
Fiscal Year
2026
Product Type
Devices
Center
CDRH
Location
Saint Paul, MN (United States)