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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
FR1-0013545-3/2/1 30-Dec-2010 80BRZ 3003238685 Shanghai Amsino Medical Devices Co., Ltd. China
 
231-8675451-4/1/1 10-Dec-2010 80FLL 3000264200 Onbo Electronics Company Limited China
 
112-9942412-1/1/1 21-Dec-2010 80FMF 3005975625 Teoxane S.A. Switzerland
 
112-9652494-9/2/3 03-Dec-2010 80FMI 3003856380 Bd Healthcare Systems United States
 
EI5-5202874-4/1/1 01-Dec-2010 80FQM 3007028032 YONGKANG BANGLI MEDICAL PRODUCTS CO., LTD China
 
EI5-5202874-4/2/1 01-Dec-2010 80FQM 3007028032 YONGKANG BANGLI MEDICAL PRODUCTS CO., LTD China
 
EI5-5202874-4/6/1 01-Dec-2010 80FQM 3007028032 YONGKANG BANGLI MEDICAL PRODUCTS CO., LTD China
 
112-9652494-9/2/6 03-Dec-2010 80FRN 3003426453 Stanislaw R Burzynski, MD United States
 
T76-0839810-5/3/1 16-Dec-2010 80KGX 3005683954 Whole Team Corp Taiwan
 
DO7-8234653-3/1/1 30-Dec-2010 80KYZ 3005448030 Dr. Reddy's Laboratories Limited (Unit II) India
 
112-9652494-9/2/2 03-Dec-2010 80KZH 3003426453 Stanislaw R Burzynski, MD United States
 
EQ6-0012021-4/1/1 02-Dec-2010 80LDQ 3006415427 Biorad France
 
BQQ-0003505-8/270/1/C 08-Dec-2010 80LDQ 3008413415 Sarepta Gorchichny Factory Russia
 
AEK-8562452-2/1/1 10-Dec-2010 80LDQ 3008472483 Guangzhou Yihao Electronic Technolo China
 
523-0915895-5/5/1 12-Dec-2010 80LNX 3008619529 Alterface Belgium
 
523-0915895-5/35/1 12-Dec-2010 80LNX 3008619529 Alterface Belgium
 
315-7343634-7/1/1 21-Dec-2010 80LYY 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
551-8728557-7/2/5 08-Dec-2010 80LYZ 3003994600 Top Glove (Zhangjigang) Co., Ltd. China
 
551-8728557-7/3/2 08-Dec-2010 80LYZ 3003994600 Top Glove (Zhangjigang) Co., Ltd. China
 
551-8728557-7/5/1 08-Dec-2010 80LYZ 3003994600 Top Glove (Zhangjigang) Co., Ltd. China
 
551-8728557-7/6/16 08-Dec-2010 80LYZ 3003994600 Top Glove (Zhangjigang) Co., Ltd. China
 
FR1-0013590-9/3/1 28-Dec-2010 80MEB 3006471098 Daiken Medical Co. Ltd. Japan
 
112-7454385-3/1/1 28-Dec-2010 80MSN 3008182199 Shenzhen Jeasun Tech Co.Tld China
 
231-1740406-5/1/1 16-Dec-2010 80MWV 3006339747 Bd Diagnostics United Kingdom
 
231-1740406-5/2/1 16-Dec-2010 80MWV 3006339747 Bd Diagnostics United Kingdom
 
231-1740406-5/3/1 16-Dec-2010 80MWV 3006339747 Bd Diagnostics United Kingdom
 
112-9652494-9/1/3 03-Dec-2010 80NZW 3003426453 Stanislaw R Burzynski, MD United States
 
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