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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
112-4957805-0/1/1 02-Dec-2011 74DPS 3009231117 Dacolink Electronic Ltd China
 
UPS-4193974-9/1/1 29-Dec-2011 74DRX 3003491392 Covidien, formerly Ludlow Technical Products Canada Ltd. Canada
 
112-4515826-1/1/1 22-Dec-2011 74DXN 3009192904 Shenzhen Changshen Technology Co., Ltd. China
 
112-4395100-6/1/1 28-Dec-2011 74DYB 3003184529 Togo Medikit Co., Ltd. Japan
 
620-2006433-3/1/1 28-Dec-2011 74LOZ 3003761017 SynCardia Systems Inc. United States
 
112-9878139-8/1/1 28-Dec-2011 74MHX 3004890521 Dpd Depot 180 Germany
 
112-4104589-2/1/1 06-Dec-2011 74NIK 3009099242 Wel Medical United Kingdom
 
112-4853861-6/1/1 16-Dec-2011 74NIQ 3005516812 Spectraytics United States
 
112-1379326-3/1/1 16-Dec-2011 74NIQ 3004091615 Abbott Vascular Devices Holland B.V. Netherlands
 
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