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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
MH9-2023083-5/1/1 05-Feb-2014 74DPS 3006981244 Cmics Medical Intrusments Co Ltd China
 
WGB-1312183-2/3/1 11-Feb-2014 74DPS 3007222337 BAIWANG MANUFACTURING PLANT, SHENZHEN MINDRAY China
 
799-2699382-9/1/1 24-Feb-2014 74DPS 2183461 Mortara Instrument, Inc United States
 
AEK-4528368-2/1/1 19-Feb-2014 74DXN 3008177000 Andon Health Co., Ltd. China
 
406-0499201-2/2/1 19-Feb-2014 74DXN 3009967103 Panasonic Manufacturing (Beijing) Co. Ltd. China
 
799-2699382-9/2/1 24-Feb-2014 74DXN 1450057 Omron Healthcare, Inc. United States
 
799-3062052-5/1/1 24-Feb-2014 74KFM 3003512469 Jarvik Heart Inc United States
 
WGB-1312183-2/1/1 11-Feb-2014 74MHX 3007222337 BAIWANG MANUFACTURING PLANT, SHENZHEN MINDRAY China
 
516-2053649-3/1/1 20-Feb-2014 74MHX 3007604008 Omnimed Ltda Brazil
 
WGB-1312183-2/2/1 11-Feb-2014 74MKJ 3007222337 BAIWANG MANUFACTURING PLANT, SHENZHEN MINDRAY China
 
EDX-0010900-9/1/3 11-Feb-2014 74MZT 3009655546 Redax S.R.L. Italy
 
MC2-6429198-0/1/1 11-Feb-2014 74NPN 3003259513 Schiller Medical Sa France
 
MC2-6429447-1/1/1 11-Feb-2014 74NPN 3010418303 Schiller Asia Pacific Sdn Bhd Malaysia
 
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