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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
MA7-0283499-9/3/1 22-Jan-2013 74DPS 3003971136 Edan Instruments, Inc. China
 
MA7-0283499-9/4/1 22-Jan-2013 74DPS 3003971136 Edan Instruments, Inc. China
 
AD4-0607654-8/1/1 09-Jan-2013 74DSP 3001418283 Maquet Datascope Corp - Cardiac Assist Division United States
 
AD4-0607654-8/1/2 09-Jan-2013 74DSP 3001418283 Maquet Datascope Corp - Cardiac Assist Division United States
 
FR1-0014566-8/2/1 31-Jan-2013 74DTR 3002533790 Nipro Medical Ltda Brazil
 
FR1-0014825-8/1/1 31-Jan-2013 74DTZ 3002533790 Nipro Medical Ltda Brazil
 
FR1-0014566-8/1/1 31-Jan-2013 74DTZ 3002533790 Nipro Medical Ltda Brazil
 
406-0478968-1/1/1 31-Jan-2013 74DXN 3005515786 Panasonic Avc Networks Xiamen Co China
 
112-0405912-1/1/1 23-Jan-2013 74MKJ 3001058874 Innovint Aircraft Interior Germany
 
112-1242600-7/1/1 28-Jan-2013 74MUD 3002807391 Nellcor Puritan Bennett Mexico, S.A. de C.V. Mexico
 
UPS-7977649-4/1/1 17-Jan-2013 74MWI 3007871360 Guoteng Science Tech Deve Co Ltd China
 
UPS-7977649-4/2/1 17-Jan-2013 74MWI 3007871360 Guoteng Science Tech Deve Co Ltd China
 
UPS-7977649-4/3/1/A 17-Jan-2013 74MWI 3007871360 Guoteng Science Tech Deve Co Ltd China
 
UPS-7977649-4/3/1/B 17-Jan-2013 74MWI 3007871360 Guoteng Science Tech Deve Co Ltd China
 
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