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Import refusals
/ WC1-7182228-9/11/1
WC1-7182228-9/11/1
Edwards Lifesciences, LLC — FEI 2015691
Recent inspections
1229680
(NAI Thu Aug 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
1194166
(NAI Tue Dec 06 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
1100450
(NAI Mon Aug 19 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
1093187
(VAI Fri Jun 14 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
959741
(NAI Fri Feb 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
Compliance actions
Warning Letter (87305)
(Mon Mar 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
Other import refusals
101-8366633-8/231/1
(Thu Oct 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
101-8218276-6/71/1
(Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
101-8218276-6/121/1
(Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
101-8218276-6/181/1
(Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
101-8218276-6/61/1
(Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
Refusal Details
Date
August 13, 2020
Country
United States
Product Category
Devices
Product Code
74DXC CLAMP, VASCULAR
Charges
508