FDA Data MCP
☰
Docs
Datasets
Pricing
Blog
Account
Statistics
Get API Key
Home
/
Import refusals
/ AEK-1104305-4/11/1
AEK-1104305-4/11/1
Oscor Inc. — FEI 1035166
Recent inspections
1151577
(VAI Fri Sep 10 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
1009131
(VAI Thu Mar 23 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
963563
(OAI Thu Mar 17 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
845108
(NAI Wed Aug 21 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
790329
(VAI Tue Jun 26 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
Compliance actions
Warning Letter (496385)
(Mon Jun 13 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
Other import refusals
799-2962187-8/21/1
(Wed Mar 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
AEK-2090800-7/1/1
(Fri Jun 17 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
DM4-0409089-4/1/1
(Fri Jul 25 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
Refusal Details
Date
May 13, 2022
Country
United States
Product Category
Devices
Product Code
74DTE PULSE-GENERATOR, PACEMAKER, EXTERNAL
Charges
118,3280,341,508