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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
WC1-8453455-8/107/1 06-Jan-2012 74DQO 1721504 Merit Medical Systems, Inc. United States
 
112-5278109-6/2/1 04-Jan-2012 74DRC 3006453991 Karl Storz GMBH & Co KG (KSVEM) Germany
 
112-5491165-9/1/1 20-Jan-2012 74DTW 3009313237 Aussimed Ltd. United Kingdom
 
112-5484225-0/1/1 17-Jan-2012 74DXT 3004056159 Medrad, Inc. dba Bayer R&I United States
 
AWM-0018712-2/4/1 17-Jan-2012 74DXY 3002807561 Medtronic B.V. Netherlands
 
AWM-0018824-5/1/1 19-Jan-2012 74DXY 3002807561 Medtronic B.V. Netherlands
 
AWM-0018755-1/2/1 30-Jan-2012 74DXY 3002807561 Medtronic B.V. Netherlands
 
112-9232302-3/1/6 06-Jan-2012 74DYB 3006992278 Surgimedik Healthcare India
 
112-7869704-4/1/1 07-Jan-2012 74LOS 3004740918 Mortara Instrument Gmbh Germany
 
112-5874811-4/1/1 07-Jan-2012 74MKI 3002452499 Herman Medizintechnik Germany
 
112-6928447-1/1/1 12-Jan-2012 74MNW 3008268202 Efg Diagnostics Limited United Kingdom
 
WC1-8454369-0/245/1 06-Jan-2012 74OEQ 3004122598 Productos Medline, S.A. de C.V. Mexico
 
WC1-8458491-8/1/1 06-Jan-2012 74OEQ 3004122598 Productos Medline, S.A. de C.V. Mexico
 
WC1-8453455-8/106/1 06-Jan-2012 74OES 3004122598 Productos Medline, S.A. de C.V. Mexico
 
WC1-8453455-8/169/1 06-Jan-2012 74OES 3004122598 Productos Medline, S.A. de C.V. Mexico
 
WC1-8453455-8/47/1 06-Jan-2012 74OES 3004122598 Productos Medline, S.A. de C.V. Mexico
 
WC1-8452844-4/96/1 06-Jan-2012 74OES 3004122598 Productos Medline, S.A. de C.V. Mexico
 
WC1-8454779-0/76/1 10-Jan-2012 74OEZ 3004122598 Productos Medline, S.A. de C.V. Mexico
 
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