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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
UPS-3990107-2/4/1 10-May-2011 78FDF 3008886048 Treier Endoscopie Ag Switzerland
 
UPS-3990107-2/6/1 10-May-2011 78FDS 3008886048 Treier Endoscopie Ag Switzerland
 
UPS-3990107-2/5/1 10-May-2011 78FDS 3008886048 Treier Endoscopie Ag Switzerland
 
BJV-0240253-6/70/1 31-May-2011 78FGM 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0240288-2/59/1 31-May-2011 78FHQ 3003145254 Everlast Surgical Company Pakistan
 
FR1-0013815-0/1/1 11-May-2011 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0013786-3/1/1 17-May-2011 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0013790-5/1/1 17-May-2011 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0013831-7/1/1 16-May-2011 78FJK 3002974635 Nipro (Thailand) Corporation Limited Thailand
 
FR1-0013803-6/1/1 17-May-2011 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0013816-8/1/1 19-May-2011 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
UPS-3990107-2/1/1 10-May-2011 78GCT 3008886048 Treier Endoscopie Ag Switzerland
 
UPS-3990107-2/2/1 10-May-2011 78GCT 3008886048 Treier Endoscopie Ag Switzerland
 
DSV-5005316-1/1/1 31-May-2011 78KGC 3006507603 Jss Corporation Japan
 
UPS-3990107-2/3/1 10-May-2011 78KOG 3008886048 Treier Endoscopie Ag Switzerland
 
UPS-2020207-9/1/1 06-May-2011 78LKY 3006891790 ANDROMEDICAL SL Spain
 
UPS-1687356-0/1/1 09-May-2011 78LKY 3006891790 ANDROMEDICAL SL Spain
 
UPS-2045779-8/1/1 10-May-2011 78LKY 3006891790 ANDROMEDICAL SL Spain
 
UPS-2101397-0/1/1 17-May-2011 78LKY 3006891790 ANDROMEDICAL SL Spain
 
UPS-1983693-7/2/1 17-May-2011 78LKY 3006891790 ANDROMEDICAL SL Spain
 
UPS-1908016-3/1/1 18-May-2011 78LKY 3006891790 ANDROMEDICAL SL Spain
 
MA7-0265011-4/1/1 31-May-2011 78LNS 3002807616 Medispec, Ltd. Israel
 
112-1577300-8/1/1 12-May-2011 78MRE 3006440700 Contipro Pharma, a.s. Czech Republic
 
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