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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
FR1-0015061-9/1/1 02-Jul-2013 80BRZ 3005669815 Amsino Medical (Kunshan) Co., Ltd. China
 
FR1-0015114-6/1/1 05-Jul-2013 80BRZ 3003238685 Shanghai Amsino Medical Devices Co., Ltd. China
 
FR1-0015047-8/1/1 09-Jul-2013 80BRZ 3003238685 Shanghai Amsino Medical Devices Co., Ltd. China
 
FR1-0015103-9/1/1 25-Jul-2013 80BRZ 3003238685 Shanghai Amsino Medical Devices Co., Ltd. China
 
XXX-0177461-2/3/1/A 11-Jul-2013 80FMF 3008007437 Unknown Multiple Countries (PODS ONLY)
 
XXX-0177778-9/2/1/D 11-Jul-2013 80FMF 3003606202 Nipro Medical Corp Chile Chile
 
UPS-8002124-2/1/1 11-Jul-2013 80FMQ 3010177452 Ellipsiz Dss Pte Ltd Singapore
 
WGB-1305208-6/1/1 17-Jul-2013 80FNL 3010199906 Chang Gung Medical Technology Co. Ltd. Taiwan
 
GR9-9023211-2/1/1 23-Jul-2013 80FPA 3010047442 Omni Manufacturing Services S.A. de C.V. Mexico
 
112-3260668-7/1/1 17-Jul-2013 80FPK 3009789882 Eldon James, Corp. United States
 
WGB-1305208-6/2/1 17-Jul-2013 80FPO 3010199906 Chang Gung Medical Technology Co. Ltd. Taiwan
 
253-1051774-0/67/1 19-Jul-2013 80FQM 3005165118 Huangmei County Mingda Foreign Trade Co.,Ltd. China
 
253-1051774-0/69/1 19-Jul-2013 80FQM 3005165118 Huangmei County Mingda Foreign Trade Co.,Ltd. China
 
253-1051774-0/70/1 19-Jul-2013 80FQM 3005165118 Huangmei County Mingda Foreign Trade Co.,Ltd. China
 
M34-7203000-6/1/1 25-Jul-2013 80FQM 3006422638 Yiwu Kaiyan Import & Export Co., Ltd. China
 
FR1-0015062-7/3/1 18-Jul-2013 80FRN 3007482089 Miyuki Elex Co.,Ltd Japan
 
M76-2091362-6/1/1 18-Jul-2013 80FSA 3006662254 1073849 Ontario Limited O/A T.H.E. Canada
 
M76-2091362-6/2/1 18-Jul-2013 80FSA 3006662254 1073849 Ontario Limited O/A T.H.E. Canada
 
M76-2091362-6/3/1 18-Jul-2013 80FSA 3006662254 1073849 Ontario Limited O/A T.H.E. Canada
 
M76-2091362-6/4/1 18-Jul-2013 80FSA 3006662254 1073849 Ontario Limited O/A T.H.E. Canada
 
M76-2091362-6/5/1 18-Jul-2013 80FSA 3006662254 1073849 Ontario Limited O/A T.H.E. Canada
 
M76-2091362-6/6/1 18-Jul-2013 80FSA 3006662254 1073849 Ontario Limited O/A T.H.E. Canada
 
336-9444293-4/2/1 31-Jul-2013 80JOK 3009222256 Wibi Instruments Pakistan
 
AT1-0132448-4/1/1 24-Jul-2013 80KGX 3009321712 Saferlife Products Hk Co Ltd China
 
FD6-3110755-0/3/1 29-Jul-2013 80KGX 3009338263 Ningbo First Import & Export Com.,Ltd China
 
MC2-6393622-1/1/1 18-Jul-2013 80KYT 3004949301 Zhenjiang Hi-Way Imp-Exp Co.,Ltd. China
 
112-3336808-9/1/1 26-Jul-2013 80KZH 3007484571 B & C Group Nv/Sa Belgium
 
EQ6-0016828-8/1/1 01-Jul-2013 80LDQ 5833 EPPENDORF AG Germany
 
MU8-0029083-3/1/1 29-Jul-2013 80LDQ 3010151271 Jian Yuan Medical Technology Co., Ltd. China
 
MU8-0029083-3/1/2 29-Jul-2013 80LDQ 3010151271 Jian Yuan Medical Technology Co., Ltd. China
 
BJY-0711433-1/1/3 24-Jul-2013 80LHI 3004181963 Mediplus Ltd United Kingdom
 
9M3-1005712-3/1/5 08-Jul-2013 80LYZ 3006534695 Jiangsu Cureguard Glove Co., Ltd. China
 
9M3-1006090-3/2/2 22-Jul-2013 80LYZ 3006534695 Jiangsu Cureguard Glove Co., Ltd. China
 
916-2471643-6/7/1 22-Jul-2013 80LYZ 3006534695 Jiangsu Cureguard Glove Co., Ltd. China
 
916-2471643-6/29/1 22-Jul-2013 80LYZ 3006534695 Jiangsu Cureguard Glove Co., Ltd. China
 
K80-1025716-1/1/1 25-Jul-2013 80LYZ 3004083416 Jintan Xinda Chemical Fibre Canvas Mill China
 
EJG-0233082-3/1/1/A 31-Jul-2013 80MQX 3009614471 Suzhou Sen Sen Medical Supplies Ltd China
 
EJG-0233082-3/1/1/B 31-Jul-2013 80MQX 3009614471 Suzhou Sen Sen Medical Supplies Ltd China
 
T94-0059995-5/1/1 22-Jul-2013 80MXI 3001451826 Swiss American Products, Inc United States
 
UPS-1352301-6/1/1 22-Jul-2013 80NSC 3006707747 Medicom A/S Denmark
 
322-0895376-4/1/1 16-Jul-2013 80OKI 3004066035 Daimer-Benz Ag Germany
 
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