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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
AGA-0006096-5/4/1 28-Aug-2006 74DPS 3003980727 MedisonXray Co., Ltd. Korea, Republic Of (South)
 
AWB-0007850-5/1/1/D 22-Aug-2006 74DQA 3007222337 BAIWANG MANUFACTURING PLANT, SHENZHEN MINDRAY China
 
AGA-0006096-5/3/1 28-Aug-2006 74DQA 3003980727 MedisonXray Co., Ltd. Korea, Republic Of (South)
 
112-2581089-6/1/1 10-Aug-2006 74DQY 3005825762 Bioheart Inc. United States
 
AWB-0007850-5/1/1/A 22-Aug-2006 74DRT 3007222337 BAIWANG MANUFACTURING PLANT, SHENZHEN MINDRAY China
 
AWB-0007850-5/1/1/B 22-Aug-2006 74DRT 3007222337 BAIWANG MANUFACTURING PLANT, SHENZHEN MINDRAY China
 
112-2792724-3/1/1 29-Aug-2006 74DTD 3002593872 Nolato Medical Ab Sweden
 
112-2703545-0/1/1 28-Aug-2006 74DXC 3002807956 QSA Surgical, Ltd. Pakistan
 
JF7-0049362-6/4/1 21-Aug-2006 74LOS 3005812362 Novamedica Colombia
 
112-2849434-2/1/1 30-Aug-2006 74LOS 3005488716 Corscience GmbH & Co. KG Germany
 
315-8153535-3/3/1 22-Aug-2006 74MKJ 3005796269 Electromedicina De Marcelo G Andrad Argentina
 
315-8153535-3/1/1 22-Aug-2006 74MKJ 3005796269 Electromedicina De Marcelo G Andrad Argentina
 
DR7-0060955-2/1/1 07-Aug-2006 74MLO 3004501760 Gevenmed Sa Venezuela
 
DR7-0060955-2/2/1 07-Aug-2006 74MLO 3004501760 Gevenmed Sa Venezuela
 
DR7-0060955-2/3/1 07-Aug-2006 74MLO 3003789483 Ge Medical Systems Kretztechnik Austria
 
DR7-0060955-2/4/1 07-Aug-2006 74MLO 3004501760 Gevenmed Sa Venezuela
 
DR7-0060955-2/5/1 07-Aug-2006 74MLO 3004501760 Gevenmed Sa Venezuela
 
AWB-0007850-5/1/1/C 22-Aug-2006 74MWI 3007222337 BAIWANG MANUFACTURING PLANT, SHENZHEN MINDRAY China
 
AWB-0007850-5/1/1/E 22-Aug-2006 74MWI 3007222337 BAIWANG MANUFACTURING PLANT, SHENZHEN MINDRAY China
 
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