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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
112-6007653-9/1/1 28-Feb-2012 74DPS 3003675391 Cardionics Sa Belgium
 
112-5690372-0/1/1 29-Feb-2012 74DPS 3009112638 Datrend Systems Inc Canada
 
112-5888661-8/1/2 14-Feb-2012 74DQA 3002807391 Nellcor Puritan Bennett Mexico, S.A. de C.V. Mexico
 
112-5888661-8/1/3 14-Feb-2012 74DQA 3002807391 Nellcor Puritan Bennett Mexico, S.A. de C.V. Mexico
 
112-5888661-8/1/4 14-Feb-2012 74DQA 3002807391 Nellcor Puritan Bennett Mexico, S.A. de C.V. Mexico
 
112-5888661-8/1/5 14-Feb-2012 74DQA 3002807391 Nellcor Puritan Bennett Mexico, S.A. de C.V. Mexico
 
UPS-5465410-4/1/1 28-Feb-2012 74DQF 3009412812 Muskoka Algonquin Health Canada
 
112-5765123-7/1/1 24-Feb-2012 74DXH 3004875694 Rdt Ltd United Kingdom
 
AWM-0018872-4/2/1 21-Feb-2012 74DXY 3002807561 Medtronic B.V. Netherlands
 
AWM-0018872-4/1/1 21-Feb-2012 74DXY 3002807561 Medtronic B.V. Netherlands
 
AWM-0018861-7/2/1 21-Feb-2012 74DXY 3002807561 Medtronic B.V. Netherlands
 
T94-0056591-5/8/1 13-Feb-2012 74ODL 1000157602 Medicon Instrumente Germany
 
629-0023614-2/3/3 16-Feb-2012 74OED 3009318015 Aglaia Healthcare Co., Limited Hong Kong SAR
 
629-0023614-2/3/2 16-Feb-2012 74OED 3009318015 Aglaia Healthcare Co., Limited Hong Kong SAR
 
629-0023614-2/3/1 16-Feb-2012 74OED 3009318015 Aglaia Healthcare Co., Limited Hong Kong SAR
 
WC1-8455136-2/218/1 23-Feb-2012 74OEQ 3004122598 Productos Medline, S.A. de C.V. Mexico
 
WC1-8459168-1/35/1 23-Feb-2012 74OES 3004122598 Productos Medline, S.A. de C.V. Mexico
 
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