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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
FR1-0015021-3/1/1 03-May-2013 80BRZ 3005669815 Amsino Medical (Kunshan) Co., Ltd. China
 
FR1-0015023-9/2/1 27-May-2013 80FLK 3008303451 SHANGHAIHUACHEN MEDICAL INSTRUMENTS CO., LTD China
 
DM9-1300645-6/1/1 13-May-2013 80FMF 3010113817 Nemoto Medical U.S., Inc United States
 
DM9-1300645-6/1/2 13-May-2013 80FMF 3010113817 Nemoto Medical U.S., Inc United States
 
DM9-1300645-6/1/3 13-May-2013 80FMF 3010113817 Nemoto Medical U.S., Inc United States
 
112-1855506-4/1/3 03-May-2013 80FMG 3009308072 Shanghai Puyi Medical Instrument China
 
112-1855506-4/2/1 03-May-2013 80FMG 3009308072 Shanghai Puyi Medical Instrument China
 
FR1-0014954-6/2/1 27-May-2013 80FOZ 3004070915 Hanako Medical Japan
 
300-7133514-3/1/2 08-May-2013 80FPA 3003442380 Unomedical Device S.A. de C.V. Mexico
 
300-7288916-3/47/1 08-May-2013 80FQM 3010127847 Metalock Engineering Sweden Sweden
 
FR1-0014995-9/1/1 27-May-2013 80FRN 3007363456 Tianjin Hanaco Xingda Medical Co., Ltd. China
 
UPS-0693605-0/4/1/B 15-May-2013 80KCT 3010061132 12f China
 
UPS-0693605-0/1/1/C 15-May-2013 80KCT 3010061132 12f China
 
UPS-0693605-0/4/1/C 15-May-2013 80KCT 3010061132 12f China
 
ARV-3226509-7/16/1 24-May-2013 80KGX 3010110005 Qingdao Hainuo Biological Engineering Co China
 
112-2273623-9/1/1 03-May-2013 80KMH 3010099969 Lorma Group Mexico
 
MH9-2012595-1/1/1 06-May-2013 80KMI 3010155317 Ningbo Hongwei Electrical & Mechanical Co Ltd China
 
AEK-0830824-5/1/1 02-May-2013 80LDQ 3010054685 Xiaoqing Deng China
 
EQ6-0016560-7/1/1 20-May-2013 80LDQ 5833 EPPENDORF AG Germany
 
231-4391915-1/1/4 02-May-2013 80LYZ 3008388225 Tangshan Jiaxing P Lastic Products Co Ltd China
 
9M3-1005433-6/1/12 07-May-2013 80LYZ 3006534695 Jiangsu Cureguard Glove Co., Ltd. China
 
BVA-0105097-6/1/1 07-May-2013 80LYZ 3007689711 SHUN TONG CO. LTD. China
 
BVA-0105097-6/2/1 07-May-2013 80LYZ 3007689711 SHUN TONG CO. LTD. China
 
BVA-0105097-6/3/1 07-May-2013 80LYZ 3007689711 SHUN TONG CO. LTD. China
 
F23-9082831-7/1/1 22-May-2013 80LYZ 3006540060 ZIBO HENGDE PLASTIC & RUBBER PRODUCTS CO., LTD. China
 
F23-9082682-4/1/1 31-May-2013 80LYZ 3006540060 ZIBO HENGDE PLASTIC & RUBBER PRODUCTS CO., LTD. China
 
MS5-3317304-5/1/1 13-May-2013 80MQX 3008466144 Yinzhou Sunse Acrylic Co., Ltd China
 
97J-0000029-4/1/1 14-May-2013 80MQX 3009323721 Enskin Korea, Republic Of (South)
 
UPS-0693605-0/1/1/A 15-May-2013 80OIG 3010061132 12f China
 
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