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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
BJY-0707789-2/3/1 02-Sep-2010 78FBQ 3005657189 Purple Surgical International United Kingdom
 
112-8710573-1/1/1 13-Sep-2010 78FGM 3007770035 Endo Flex Gmbh Germany
 
BJV-0229694-6/13/2 28-Sep-2010 78FHQ 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0229694-6/3/1/C 28-Sep-2010 78FHQ 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0229694-6/10/2 28-Sep-2010 78FHQ 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
AEK-8310714-0/1/3 29-Sep-2010 78FHQ 3274 Acme Surgical Industries (Pvt) Ltd. Pakistan
 
FR1-0013479-5/2/1 27-Sep-2010 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0013426-6/3/1 28-Sep-2010 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
112-8529963-5/1/1 14-Sep-2010 78FJP 3003018304 Ecm Bv Netherlands
 
BJY-0707910-4/2/2 14-Sep-2010 78FKN 3008459205 Hll Lifecare Limited India
 
FR1-0013385-4/1/1 02-Sep-2010 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
FR1-0013386-2/1/1 02-Sep-2010 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0013477-9/1/1 27-Sep-2010 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0013477-9/2/1 27-Sep-2010 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
FR1-0013428-2/1/1 28-Sep-2010 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0013428-2/2/1 28-Sep-2010 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
BJY-0707912-0/2/1 07-Sep-2010 78KPI 3008459630 Emd Medikal Elekanik Yaz Dan San Ve Tic Ltd Turkey
 
UPS-8931321-5/1/1 02-Sep-2010 78LKY 3008196036 X4 Labs Inc Canada
 
UPS-8931251-4/1/1 02-Sep-2010 78LKY 3008196036 X4 Labs Inc Canada
 
112-8227980-5/1/1 10-Sep-2010 78LKY 3007335337 Ultramax Products United Kingdom
 
UPS-8852835-9/1/1 14-Sep-2010 78LKY 3008196036 X4 Labs Inc Canada
 
UPS-8931155-7/1/1 14-Sep-2010 78LKY 3008196036 X4 Labs Inc Canada
 
UPS-8931214-2/1/1 14-Sep-2010 78LKY 3008196036 X4 Labs Inc Canada
 
UPS-8931340-5/1/1 14-Sep-2010 78LKY 3008196036 X4 Labs Inc Canada
 
BJY-0707912-0/1/1 07-Sep-2010 78LNS 3008459630 Emd Medikal Elekanik Yaz Dan San Ve Tic Ltd Turkey
 
BJY-0707789-2/3/3 02-Sep-2010 78OCZ 3005657189 Purple Surgical International United Kingdom
 
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