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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
MH9-0091387-1/1/1 17-May-2011 80FLE 3007138511 Shandong Xinhua Medical Instrument Co Ltd China
 
E41-0068900-6/1/1/B 11-May-2011 80FMC 3007923136 ZIBO YUSHENG PLASTIC PRODUCTS COMPANY LIMITED China
 
146-0024765-5/1/2 04-May-2011 80FMF 3008431755 Orthos Limited United Kingdom
 
390-6365009-5/1/1 17-May-2011 80FNL 3007176145 Carroll Hospital Group Inc Canada
 
AEK-8726005-1/1/2 12-May-2011 80FPA 3007298902 Unomedical A/S Denmark
 
AEK-8726005-1/1/1 12-May-2011 80FPA 3007298902 Unomedical A/S Denmark
 
BJV-0238029-4/2/1 27-May-2011 80FQM 3004710519 Convertors De Mexico Mexico
 
BJV-0238029-4/3/1 27-May-2011 80FQM 3004710519 Convertors De Mexico Mexico
 
BJV-0238029-4/5/1 27-May-2011 80FQM 3004710519 Convertors De Mexico Mexico
 
322-0459880-3/1/1 06-May-2011 80FSA 3008834141 Buseloc Belgium Belgium
 
322-0459880-3/11/1 06-May-2011 80FSA 3008644527 Vitezis Ltd Macedonia
 
322-0459880-3/12/1 06-May-2011 80FSA 3006046190 Us Pacific Procurement Co.,Ltd Hong Kong SAR
 
231-2714666-4/1/3 04-May-2011 80KGX 3007028032 YONGKANG BANGLI MEDICAL PRODUCTS CO., LTD China
 
231-2714666-4/1/1 04-May-2011 80KGX 3007028032 YONGKANG BANGLI MEDICAL PRODUCTS CO., LTD China
 
231-2714666-4/1/2 04-May-2011 80KGX 3007028032 YONGKANG BANGLI MEDICAL PRODUCTS CO., LTD China
 
BQL-0025994-3/13/1 17-May-2011 80KGX 3008510654 Assol Ooo Russia
 
BQL-0025994-3/13/2 17-May-2011 80KGX 3008510654 Assol Ooo Russia
 
BQL-0025994-3/13/3 17-May-2011 80KGX 3008510654 Assol Ooo Russia
 
XXX-0269136-9/1/9 04-May-2011 80KZH 3006334810 Nipro Thailand Co Thailand
 
XXX-0270745-4/1/4 04-May-2011 80KZH 3002806469 B. Braun Melsungen AG Germany
 
XXX-0269704-4/1/2 17-May-2011 80KZH 3000247873 Nipro Corporation Japan
 
AEK-8741452-6/2/1 24-May-2011 80KZH 3008909260 Chirana Injecta A.S. Slovakia
 
231-1475693-7/3/1 11-May-2011 80LDQ 3005193559 Influx Industry Inc China
 
231-1475693-7/3/2 11-May-2011 80LDQ 3005193559 Influx Industry Inc China
 
231-1475693-7/3/3 11-May-2011 80LDQ 3005193559 Influx Industry Inc China
 
AEK-8370432-6/1/1/A 16-May-2011 80LDQ 3008813775 Ladycare Lifetime Ltd United Kingdom
 
AEK-8370432-6/1/1/B 16-May-2011 80LDQ 3008813775 Ladycare Lifetime Ltd United Kingdom
 
EQ6-0013113-8/1/1 17-May-2011 80LDQ 5833 EPPENDORF AG Germany
 
E41-0069189-5/1/4 12-May-2011 80LYY 3007923136 ZIBO YUSHENG PLASTIC PRODUCTS COMPANY LIMITED China
 
E41-0069189-5/1/5 12-May-2011 80LYY 3007923136 ZIBO YUSHENG PLASTIC PRODUCTS COMPANY LIMITED China
 
E41-0069190-3/1/2 11-May-2011 80LYZ 3007923136 ZIBO YUSHENG PLASTIC PRODUCTS COMPANY LIMITED China
 
E41-0069189-5/1/1 12-May-2011 80LYZ 3008559257 Hebei Excellent Plastic Co Ltd China
 
E41-0069189-5/1/2 12-May-2011 80LYZ 3008559257 Hebei Excellent Plastic Co Ltd China
 
E41-0069189-5/1/3 12-May-2011 80LYZ 3008559257 Hebei Excellent Plastic Co Ltd China
 
E41-0069259-6/1/2 16-May-2011 80LYZ 3007923136 ZIBO YUSHENG PLASTIC PRODUCTS COMPANY LIMITED China
 
E41-0069260-4/1/2 16-May-2011 80LYZ 3007923136 ZIBO YUSHENG PLASTIC PRODUCTS COMPANY LIMITED China
 
279-9058689-6/1/1 17-May-2011 80LYZ 3008475293 Tangshan Excellence Glove Co Ltd China
 
113-4947833-6/52/1 25-May-2011 80LYZ 3003116612 Shijiazhuang Great Vision Plastic Products Co., Ltd. China
 
315-7350354-2/1/1 31-May-2011 80LYZ 3004553390 Perusahaan Getah Asas Sdn Bhd Malaysia
 
112-1738756-7/1/1 03-May-2011 80MQX 3008861128 Exchange Supplies United Kingdom
 
AEK-8741452-6/3/1 24-May-2011 80MWV 3008909260 Chirana Injecta A.S. Slovakia
 
E41-0068477-5/1/1/B 11-May-2011 80NPC 3007923136 ZIBO YUSHENG PLASTIC PRODUCTS COMPANY LIMITED China
 
UPS-2222010-3/1/1 31-May-2011 80NSC 3005332567 Antars Pharma United States
 
279-6074480-6/1/1 03-May-2011 80OSI 3004562815 Xiamen World Gear Sports Goods Co. China
 
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