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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
112-6164723-9/1/1 07-Mar-2012 74DPS 3003675391 Cardionics Sa Belgium
 
UPS-5591355-8/1/1 21-Mar-2012 74DPS 1000520092 QRS Diagnostic United States
 
112-5553759-4/1/1 21-Mar-2012 74DQA 3001227743 Oridion Medical 1987 Ltd. Israel
 
AWM-0019073-8/1/1 14-Mar-2012 74DRF 3002807561 Medtronic B.V. Netherlands
 
112-6044330-9/1/1 20-Mar-2012 74DRX 3008127614 Clearstone Central Labs Canada
 
112-5960513-2/1/9 13-Mar-2012 74DSF 3007197015 Datex-Ohmeda United States
 
322-0632667-4/1/1 01-Mar-2012 74DSP 3003859046 Fis Tec Canada
 
FR1-0014311-9/2/1 22-Mar-2012 74DXE 3002807710 Nipro Corporation - Ohdate Factory Japan
 
AWM-0018780-9/1/1 08-Mar-2012 74DXY 3002807561 Medtronic B.V. Netherlands
 
AWM-0018777-5/2/1 08-Mar-2012 74DXY 3002807561 Medtronic B.V. Netherlands
 
AWM-0019013-4/1/1 22-Mar-2012 74DXY 3002807561 Medtronic B.V. Netherlands
 
AWM-0019013-4/2/1 22-Mar-2012 74DXY 3002807561 Medtronic B.V. Netherlands
 
112-5721816-9/1/1 14-Mar-2012 74DYB 3009264968 Elos Medtech Micro Sweden
 
112-6125784-9/1/1 30-Mar-2012 74MAF 3009937642 Meko Germany
 
AEK-8624612-7/1/1 02-Mar-2012 74MWI 3009403262 Bionet Co Ltd United States
 
AWM-0019073-8/2/1 14-Mar-2012 74NVN 3002807561 Medtronic B.V. Netherlands
 
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