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Warning Letter

Case 718762 — FEI 3004007782

Facility

Recent inspections

  • 1276707 (NAI Wed Jul 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1163848 (NAI Tue Feb 15 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1042731 (NAI Wed Feb 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 989459 (NAI Thu Oct 27 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 894694 (VAI Thu Sep 04 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

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