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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
FR1-0015116-1/1/1 30-Aug-2013 80BRZ 3003238685 Shanghai Amsino Medical Devices Co., Ltd. China
 
MH9-2015042-1/1/1 20-Aug-2013 80FLE 3006387427 Ningbo Jiangbei Woson Medical Instruments China
 
112-3405114-8/1/1 01-Aug-2013 80FLL 3005790059 Pelimex Sa France
 
BQR-0002632-0/31/1 07-Aug-2013 80FLL 3003247551 Rossmax International Ltd. Taiwan
 
406-0493285-1/9/1 15-Aug-2013 80FMP 3003999451 Fresco Podologia S.L. Spain
 
BJY-0711462-0/1/1 15-Aug-2013 80FMZ 3009670593 Arroba Ingenieria Sa De Cv Mexico
 
406-0493285-1/7/1 15-Aug-2013 80FNG 3008892760 Tecnodisco Sa Spain
 
EDX-0010574-2/1/1 06-Aug-2013 80FNL 3010243640 Kenkar United States
 
BJY-0711337-4/1/1 06-Aug-2013 80FNL 3007834672 Hospimetal Ind Metal Equip Brazil
 
FR1-0015110-4/2/1 29-Aug-2013 80FOZ 3004070915 Hanako Medical Japan
 
BJY-0711510-6/1/1 15-Aug-2013 80FPO 3010311193 Jiangsu Rixin Medical Equipment China
 
700-0137460-5/2/1 28-Aug-2013 80FQM 3010264595 Yiwu Yuhong Bandage Factory China
 
BJY-0711414-1/3/1 26-Aug-2013 80FRK 3009674567 Wem Equipamentos Electronicos Ltda Brazil
 
FR1-0015104-7/2/1 14-Aug-2013 80FRN 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0015118-7/1/1 14-Aug-2013 80FRN 3007363456 Tianjin Hanaco Xingda Medical Co., Ltd. China
 
M76-2097638-3/1/1 09-Aug-2013 80FSA 3006662254 1073849 Ontario Limited O/A T.H.E. Canada
 
M76-2097638-3/2/1 09-Aug-2013 80FSA 3006662254 1073849 Ontario Limited O/A T.H.E. Canada
 
406-0493285-1/8/8 15-Aug-2013 80KDP 3003211413 Hersill, S.L. Spain
 
EKX-0910516-8/1/4 02-Aug-2013 80KGX 3005083505 ZHEJIANG HONGYU MEDICAL COMMODITY CO., LTD., China
 
EKX-0910516-8/1/5 02-Aug-2013 80KGX 3005083505 ZHEJIANG HONGYU MEDICAL COMMODITY CO., LTD., China
 
EKX-0910528-3/1/1 02-Aug-2013 80KGX 3005083505 ZHEJIANG HONGYU MEDICAL COMMODITY CO., LTD., China
 
BJY-0711463-8/1/1 15-Aug-2013 80KMI 3010295684 Medica D, S.A. De C.V. Mexico
 
BJY-0711463-8/2/1 15-Aug-2013 80KMI 3010295684 Medica D, S.A. De C.V. Mexico
 
BJY-0711463-8/3/1 15-Aug-2013 80KMI 3010295684 Medica D, S.A. De C.V. Mexico
 
BJY-0711463-8/4/1 15-Aug-2013 80KMI 3010295684 Medica D, S.A. De C.V. Mexico
 
BJY-0711465-3/1/1 15-Aug-2013 80KMI 3009670023 Medi Care Group S.A. De C.V. Mexico
 
BJY-0711465-3/2/1 15-Aug-2013 80KMI 3009670023 Medi Care Group S.A. De C.V. Mexico
 
BJY-0711465-3/3/1 15-Aug-2013 80KMI 3009670023 Medi Care Group S.A. De C.V. Mexico
 
HH7-0308210-2/9/1 20-Aug-2013 80KMI 3010330198 Fae Famed Ldz Poland
 
406-0493285-1/14/1 15-Aug-2013 80KYS 1000626221 Prim S.A. Spain
 
406-0493285-1/10/9 15-Aug-2013 80KYS 3008408655 Orliman, S.L. Spain
 
406-0493285-1/13/3 15-Aug-2013 80KYS 3003999451 Fresco Podologia S.L. Spain
 
HH7-0308210-2/2/1 20-Aug-2013 80KYT 3010330198 Fae Famed Ldz Poland
 
HH7-0308210-2/2/2 20-Aug-2013 80KYT 3010330198 Fae Famed Ldz Poland
 
HH7-0308210-2/2/3 20-Aug-2013 80KYT 3010330198 Fae Famed Ldz Poland
 
EQ6-0016964-1/1/1 09-Aug-2013 80LDQ 5833 EPPENDORF AG Germany
 
UPS-1327550-0/1/1 12-Aug-2013 80LDQ 3010201924 Michi International United States
 
UPS-1069509-8/1/1 12-Aug-2013 80LDQ 3010201924 Michi International United States
 
EL6-0030783-8/4/1 21-Aug-2013 80LDQ 3010321017 Ulikia Technology Co Ltd China
 
BSF-0021196-9/2/1 29-Aug-2013 80LDQ 3008855402 Mec Korea Co Korea, Republic Of (South)
 
AZE-0062128-9/4/1 13-Aug-2013 80LKB 3003096921 Qingdao Shuang China
 
AZE-0062128-9/8/1 13-Aug-2013 80LKB 3008876079 Qingdao Mingruixing Trading Co China
 
AZE-0062153-7/6/1 13-Aug-2013 80LKB 3003096921 Qingdao Shuang China
 
AZE-0062153-7/7/1 13-Aug-2013 80LKB 3008876079 Qingdao Mingruixing Trading Co China
 
AZE-0062192-5/4/1 13-Aug-2013 80LKB 3003096921 Qingdao Shuang China
 
AZE-0062192-5/8/1 13-Aug-2013 80LKB 3008876079 Qingdao Mingruixing Trading Co China
 
406-0493285-1/16/4 15-Aug-2013 80LLI 3008892760 Tecnodisco Sa Spain
 
406-0493285-1/16/3 15-Aug-2013 80LLI 3008892760 Tecnodisco Sa Spain
 
406-0493285-1/16/5 15-Aug-2013 80LLI 3008892760 Tecnodisco Sa Spain
 
406-0493285-1/16/2 15-Aug-2013 80LLI 3008892760 Tecnodisco Sa Spain
 
406-0493285-1/16/1 15-Aug-2013 80LLI 3008892760 Tecnodisco Sa Spain
 
799-0146014-1/1/1 26-Aug-2013 80LLI 3003151040 Touch America Inc United States
 
GL5-0313082-2/1/1 26-Aug-2013 80LYY 1000283080 W.A. Rubbermate Co., Ltd. Thailand
 
MC2-6395161-8/1/1 07-Aug-2013 80LYZ 3007143709 SHIJIAZHUANG PROSPEROUS PLASTIC CO., LTD China
 
MC2-6395161-8/2/1 07-Aug-2013 80LYZ 3009353054 ZHAOYANG PLASTIC CO LTD China
 
231-6128826-5/1/1 08-Aug-2013 80LYZ 3006540060 ZIBO HENGDE PLASTIC & RUBBER PRODUCTS CO., LTD. China
 
231-6128826-5/1/2 08-Aug-2013 80LYZ 3006540060 ZIBO HENGDE PLASTIC & RUBBER PRODUCTS CO., LTD. China
 
MA7-0209049-3/1/1 08-Aug-2013 80LYZ 3008388236 Tangshan Hengtong Plastic Products Co Ltd China
 
MC2-6361496-8/1/1 16-Aug-2013 80LYZ 3008889683 Hebei Favor Plastic Co., Ltd China
 
MC2-6361496-8/2/1 16-Aug-2013 80LYZ 3009353054 ZHAOYANG PLASTIC CO LTD China
 
WC1-8622374-7/78/1 20-Aug-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
336-9457844-8/1/3 15-Aug-2013 80MMP 3006581049 Microtek Medical Malta Limited Malta & Gozo
 
AEK-9238293-2/1/1 08-Aug-2013 80NSC 3010202389 Naxing Suzhou Bionanotech China
 
BJY-0711476-0/1/1 14-Aug-2013 80ONM 3000315977 Fanem Ltda Brazil
 
BJY-0711493-5/1/1 16-Aug-2013 80ONM 3010295684 Medica D, S.A. De C.V. Mexico
 
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