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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 80-General Hospital/Personal Use


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
FR1-0013666-7/2/1 17-Apr-2011 80BRZ 3003238685 Shanghai Amsino Medical Devices Co., Ltd. China
 
MH9-0089867-6/1/1 05-Apr-2011 80FLE 3006387427 Ningbo Jiangbei Woson Medical Instruments China
 
MH9-0090224-7/1/1 15-Apr-2011 80FLE 3007138511 Shandong Xinhua Medical Instrument Co Ltd China
 
D99-5080435-8/3/1 18-Apr-2011 80FMQ 3008792388 Obaili Manufacturing Ltd China
 
112-1370894-9/1/1 15-Apr-2011 80FMR 3004132708 Faaborg Rehab Technic Aps Denmark
 
UPS-1742288-8/1/1 04-Apr-2011 80FNL 3007176145 Carroll Hospital Group Inc Canada
 
FR1-0013744-2/1/1 11-Apr-2011 80FOZ 3004070915 Hanako Medical Japan
 
FR1-0013717-8/2/1 17-Apr-2011 80FOZ 3004070915 Hanako Medical Japan
 
FR1-0013638-6/4/1 13-Apr-2011 80FRN 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0013693-1/4/1 13-Apr-2011 80FRN 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0013763-2/3/1 28-Apr-2011 80FRN 3007482089 Miyuki Elex Co.,Ltd Japan
 
UPS-1875377-8/1/1 29-Apr-2011 80JOJ 3000255542 Medisafe U.K., Ltd. United Kingdom
 
EJD-0005995-5/2/1 01-Apr-2011 80KGX 3007028032 YONGKANG BANGLI MEDICAL PRODUCTS CO., LTD China
 
UPS-5393497-5/6/1 04-Apr-2011 80KGX 3005616768 Laboratorios Leroy Mexico
 
ARV-2801170-3/1/1 21-Apr-2011 80KGX 3007028032 YONGKANG BANGLI MEDICAL PRODUCTS CO., LTD China
 
112-1338758-7/1/1 20-Apr-2011 80KZD 3008820493 Gverbet Spa Italy
 
EQ6-0012884-5/1/1 04-Apr-2011 80LDQ 5833 EPPENDORF AG Germany
 
BMW-0028259-4/1/1 21-Apr-2011 80LYY 3007695695 SHUN DA (XINGHUA) CO., LTD. China
 
224-2072099-1/3/1 21-Apr-2011 80LYY 1000153953 Laglove Sdn Bhd (M) aka LA Glove Malaysia
 
UPS-2759849-2/4/1 05-Apr-2011 80LYZ 3008191396 Zibo Intco Medical Products Company Limited China
 
231-9697371-6/1/1 04-Apr-2011 80MWV 3006339747 Bd Diagnostics United Kingdom
 
112-1794455-7/1/1 19-Apr-2011 80NRW 3000155035 Intronix Technologies Corporation Canada
 
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