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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
BJV-0245334-9/14/7 25-Jul-2012 78FDE 3004710519 Convertors De Mexico Mexico
 
AEK-0382348-7/1/3 23-Jul-2012 78FHQ 1000347621 Surgicon (Pvt) Limited Pakistan
 
T94-0057389-3/1/3 24-Jul-2012 78FHQ 3009527283 Synthes S.M.P. S.A. De C.V. Mexico
 
FR1-0014548-6/2/1 13-Jul-2012 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0014178-2/1/1 24-Jul-2012 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0014403-4/3/1 24-Jul-2012 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0014530-4/1/1 13-Jul-2012 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
FR1-0014458-8/2/1 24-Jul-2012 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
FR1-0014458-8/1/1 24-Jul-2012 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
112-7507006-3/1/1 03-Jul-2012 78LKY 3008741425 Danalife ApS Denmark
 
UPS-6682522-1/1/1 24-Jul-2012 78LKY 3006891323 X4 Labs Inc. Canada
 
UPS-6682566-8/1/1/A 24-Jul-2012 78LKY 3008196036 X4 Labs Inc Canada
 
UPS-6682566-8/1/1/B 24-Jul-2012 78LKY 3008196036 X4 Labs Inc Canada
 
UPS-6696400-4/1/1 24-Jul-2012 78LKY 3008196036 X4 Labs Inc Canada
 
UPS-6696458-2/1/1 24-Jul-2012 78LKY 3008196036 X4 Labs Inc Canada
 
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