FDA Data MCP
☰
Docs
Datasets
Pricing
Blog
Account
Statistics
Get API Key
Home
/
Import refusals
/ 112-5147602-4/1/1
112-5147602-4/1/1
Envoy Medical Corporation — FEI 3004007782
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))
Compliance actions
Warning Letter (718762)
(Thu Nov 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
Refusal Details
Date
January 7, 2005
Country
United States
Product Category
Devices
Product Code
87MOO ORTHOPEDIC IMPLANT MATERIAL
Charges
118