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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 74-Cardiovascular


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
799-1844961-6/1/1 03-Dec-2013 74DQA 3009760937 Masimo Mexico Mexico
 
799-1942859-3/1/1 23-Dec-2013 74DQA 3006733253 Shenzhen Creative Industry Co Ltd China
 
799-1347834-7/1/2 02-Dec-2013 74DQX 3005883336 Mitralign Inc United States
 
799-1347834-7/1/3 02-Dec-2013 74DQX 3005883336 Mitralign Inc United States
 
799-1685738-0/1/1 05-Dec-2013 74DXN 3010485091 Shenzhen Minghuangda Electronic Co., Ltd. China
 
406-0496779-0/2/1 12-Dec-2013 74DXN 3009967103 Panasonic Manufacturing (Beijing) Co. Ltd. China
 
EDX-0010820-9/1/1 02-Dec-2013 74DYG 3010429521 Vitromed Healthcare India
 
UPS-3350011-9/1/1 27-Dec-2013 74LWX 3009793241 Caretron Gmbh Germany
 
EDX-0010839-9/1/1 12-Dec-2013 74NIQ 3008992085 Abbott Vascular Netherlands B.V. Netherlands
 
EDX-0010840-7/1/1 12-Dec-2013 74NIQ 3008992085 Abbott Vascular Netherlands B.V. Netherlands
 
EDX-0010857-1/1/1 20-Dec-2013 74NIQ 3008992085 Abbott Vascular Netherlands B.V. Netherlands
 
EDX-0010856-3/1/1 20-Dec-2013 74NIQ 3008992085 Abbott Vascular Netherlands B.V. Netherlands
 
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