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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
112-8481955-6/1/2 12-Oct-2007 74DPT 3003616071 Itamar Medical Ltd. Israel
 
BVU-0072920-5/1/1 15-Oct-2007 74DQA 3003738823 Mek Co Ltd Korea, Republic Of (South)
 
BVU-0072920-5/1/2 15-Oct-2007 74DQA 3003738823 Mek Co Ltd Korea, Republic Of (South)
 
BVU-0072920-5/1/3 15-Oct-2007 74DQA 3003738823 Mek Co Ltd Korea, Republic Of (South)
 
G43-0069669-2/2/1 30-Oct-2007 74DRT 3007222337 BAIWANG MANUFACTURING PLANT, SHENZHEN MINDRAY China
 
406-0405621-4/2/1 22-Oct-2007 74DXN 3005124466 Panasonic Logistics (Hong Kong) Hong Kong SAR
 
100-1385471-5/1/1 03-Oct-2007 74LDE 3005748556 Ningbo Detian Medical Instruments Co., Ltd. China
 
AEK-7691287-8/1/1 22-Oct-2007 74MAF 3004536577 Conor Med Systems United States
 
112-8029373-1/1/1 27-Oct-2007 74MAF 3005296181 Edwards Lifescienc Singapore
 
112-8481955-6/1/1 12-Oct-2007 74MFY 3003616071 Itamar Medical Ltd. Israel
 
112-8144078-6/1/1 10-Oct-2007 74MUD 3004193701 Newtech Inc. China
 
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