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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
231-9183842-7/1/1 04-Mar-2013 74DPS 3004073725 Benchmark Electronics (Th) Public Co., Ltd Thailand
 
MH9-2010870-0/1/1 26-Mar-2013 74DPS 3003758059 Susuken Co Ltd Japan
 
610-8705559-8/1/1 21-Mar-2013 74DTL 3007276335 Sunny Medical Devi China
 
FR1-0014917-3/3/1 05-Mar-2013 74DTR 3002533790 Nipro Medical Ltda Brazil
 
FR1-0014917-3/1/1 05-Mar-2013 74DTZ 3002533790 Nipro Medical Ltda Brazil
 
FR1-0014917-3/2/1 05-Mar-2013 74DTZ 3002533790 Nipro Medical Ltda Brazil
 
406-0486446-8/1/1 04-Mar-2013 74DXN 3009967103 Panasonic Manufacturing (Beijing) Co. Ltd. China
 
AEK-0296350-8/1/1 04-Mar-2013 74DXN 1036863 Suntech Medical, Inc. United States
 
112-1390647-8/1/1 01-Mar-2013 74JOP 3005956475 Kmt Gmbh Germany
 
D97-0686609-9/1/1 14-Mar-2013 74LDD 3003288604 Lan Chile Sa Chile
 
AM1-0182498-6/1/2 04-Mar-2013 74MKJ 1218058 Bio-Detek, Inc. United States
 
AM1-0182498-6/1/1 04-Mar-2013 74MKJ 1218058 Bio-Detek, Inc. United States
 
MH9-2010052-5/1/1 08-Mar-2013 74MRM 3010039667 Cong Ty Co Phan Tan Vlet My Vietnam
 
112-1748872-1/1/1 08-Mar-2013 74MWS 3010031840 Beijing MEDOS AT Biotechnology Co. Ltd China
 
112-1150759-1/1/1 01-Mar-2013 74NIO 3009937642 Meko Germany
 
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