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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 85-Obstetrical & Gynecological


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
AZW-0056117-9/1/1 29-Sep-2011 85HEM 3007222337 BAIWANG MANUFACTURING PLANT, SHENZHEN MINDRAY China
 
112-8187972-0/9/1 09-Sep-2011 85HHD 3008447410 Batist S.R.O. Czech Republic
 
BSF-0014898-9/1/1 27-Sep-2011 85LQT 3009097944 Xuzhou Innovation Med Instr Co China
 
UPS-3469493-1/1/1 28-Sep-2011 85MGK 3008350665 Shenzhen Well.d Medical Electronics Co., Ltd. China
 
112-8014875-4/1/1 09-Sep-2011 85MQL 3007530035 Kitazato Biopharma Co., Ltd. Japan
 
KC2-1010066-7/1/1 12-Sep-2011 85NUC 3006537003 Glyde Health Pty Ltd Australia Australia
 
KC2-1010066-7/1/2 12-Sep-2011 85NUC 3006537003 Glyde Health Pty Ltd Australia Australia
 
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