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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 78-Gastroenterological & Urological


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
AZO-0048261-6/1/1 04-Dec-2013 78EXX 3010456025 Core Therm Medical Inc Sweden
 
AEK-7843093-7/1/1 11-Dec-2013 78FCL 3010460958 Endo-Technik Germany
 
799-1835747-0/1/1 27-Dec-2013 78FER 3005342012 Barwon Health Geelong Hospital Australia
 
UPS-3491625-6/1/1 31-Dec-2013 78FFX 1000540736 Mui Scientific Canada
 
FR1-0015313-4/3/1 02-Dec-2013 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0015326-6/1/1 26-Dec-2013 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0015339-9/2/1 20-Dec-2013 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
FR1-0015339-9/1/1 20-Dec-2013 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
AEK-1767270-6/1/1 31-Dec-2013 78GCK 3007305971 Huger Endoscopy Instruments Co Ltd China
 
799-1606546-3/1/1 13-Dec-2013 78KNS 3005442923 EMcision Ltd. United Kingdom
 
799-1166627-3/1/1 18-Dec-2013 78KOG 3010417371 Vantage Net Services Japan
 
799-1601785-2/1/1 12-Dec-2013 78LKY 3009510223 Um Products Ltd United Kingdom
 
AEK-1690703-8/1/1 16-Dec-2013 78LKY 3008023386 Cyrex Limited United Kingdom
 
799-1077392-2/1/1 18-Dec-2013 78LKY 3009608482 Bathmate Direct United Kingdom
 
799-1429314-1/1/1 18-Dec-2013 78LKY 3009510223 Um Products Ltd United Kingdom
 
UPS-3570322-4/3/1/B 20-Dec-2013 78LKY 3007962592 Suzhou Armocon Technology Co.Ltd China
 
UPS-3620690-4/1/1/B 20-Dec-2013 78LKY 3007962592 Suzhou Armocon Technology Co.Ltd China
 
UPS-3499385-9/1/1/B 23-Dec-2013 78LKY 3007962592 Suzhou Armocon Technology Co.Ltd China
 
UPS-3595549-3/4/1/B 23-Dec-2013 78LKY 3007962592 Suzhou Armocon Technology Co.Ltd China
 
UPS-3540462-5/1/1/C 23-Dec-2013 78LKY 3007962592 Suzhou Armocon Technology Co.Ltd China
 
UPS-3540462-5/1/1/D 23-Dec-2013 78LKY 3007962592 Suzhou Armocon Technology Co.Ltd China
 
UPS-3555208-4/3/1/B 23-Dec-2013 78LKY 3007962592 Suzhou Armocon Technology Co.Ltd China
 
UPS-3555208-4/3/1/C 23-Dec-2013 78LKY 3007962592 Suzhou Armocon Technology Co.Ltd China
 
UPS-3598314-9/1/1/B 23-Dec-2013 78LKY 3007962592 Suzhou Armocon Technology Co.Ltd China
 
UPS-3598314-9/1/1/C 23-Dec-2013 78LKY 3007962592 Suzhou Armocon Technology Co.Ltd China
 
UPS-3554934-6/1/1/B 23-Dec-2013 78LKY 3009916114 Suzhou Tito Industry & Trading Co., China
 
UPS-3581392-4/7/1/B 23-Dec-2013 78LKY 3007962592 Suzhou Armocon Technology Co.Ltd China
 
UPS-3595429-8/1/1/B 23-Dec-2013 78LKY 3007962592 Suzhou Armocon Technology Co.Ltd China
 
UPS-3606284-4/1/1 23-Dec-2013 78LKY 3007962592 Suzhou Armocon Technology Co.Ltd China
 
799-2089534-3/2/1 23-Dec-2013 78LKY 3009510223 Um Products Ltd United Kingdom
 
799-1188179-9/1/1 18-Dec-2013 78LST 3009608482 Bathmate Direct United Kingdom
 
FR1-0015356-3/2/1 26-Dec-2013 78NNW 3005669815 Amsino Medical (Kunshan) Co., Ltd. China
 
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