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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
112-7842843-1/1/2 11-Aug-2010 78FAJ 3002808268 Karl Storz GmbH & Co. KG Germany
 
FR1-0013318-5/1/1 04-Aug-2010 78FAQ 3003279193 Amsino Medical Instrument Co Ltd China
 
231-9084564-7/3/1 06-Aug-2010 78FCE 3008330434 Spanlink Internati Taiwan
 
750-0138477-7/1/3 20-Aug-2010 78FHQ 3002138952 M/S. Mibe Corporation Pakistan
 
750-0138477-7/1/8 20-Aug-2010 78FHQ 3002138952 M/S. Mibe Corporation Pakistan
 
750-0136294-8/1/8 21-Aug-2010 78FHQ 3002138952 M/S. Mibe Corporation Pakistan
 
750-0136294-8/1/9 21-Aug-2010 78FHQ 3002138952 M/S. Mibe Corporation Pakistan
 
750-0136294-8/1/10 21-Aug-2010 78FHQ 3002138952 M/S. Mibe Corporation Pakistan
 
750-0136294-8/1/11 21-Aug-2010 78FHQ 3002138952 M/S. Mibe Corporation Pakistan
 
750-0136294-8/1/12 21-Aug-2010 78FHQ 3002138952 M/S. Mibe Corporation Pakistan
 
750-0136294-8/1/13 21-Aug-2010 78FHQ 3002138952 M/S. Mibe Corporation Pakistan
 
750-0136294-8/1/14 21-Aug-2010 78FHQ 3002138952 M/S. Mibe Corporation Pakistan
 
750-0136294-8/1/35 21-Aug-2010 78FHQ 3002138952 M/S. Mibe Corporation Pakistan
 
750-0136294-8/1/41 21-Aug-2010 78FHQ 3002138952 M/S. Mibe Corporation Pakistan
 
WFX-1025102-7/3/1 26-Aug-2010 78FHQ 3003745141 Quality Point International Pakistan
 
FR1-0013328-4/2/1 04-Aug-2010 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0013327-6/1/1 23-Aug-2010 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0013376-3/2/1 23-Aug-2010 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0013435-7/1/1 31-Aug-2010 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0013336-7/1/1 23-Aug-2010 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0013336-7/1/2 23-Aug-2010 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0013430-8/1/1 31-Aug-2010 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0013430-8/2/1 31-Aug-2010 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
750-0138477-7/1/37 20-Aug-2010 78GCI 3002138952 M/S. Mibe Corporation Pakistan
 
N05-0265608-0/1/1 30-Aug-2010 78GCI 3008427261 Britmed Uk Ltd United Kingdom
 
112-7842843-1/1/1 11-Aug-2010 78KOG 3003637092 Olympus Medical Systems Corp. Japan
 
UPS-8821205-3/1/1 03-Aug-2010 78LKY 3008196036 X4 Labs Inc Canada
 
UPS-8821269-9/1/1 03-Aug-2010 78LKY 3008196036 X4 Labs Inc Canada
 
112-7760569-1/1/1 19-Aug-2010 78LKY 3008382287 Ultramax Products Ltd United Kingdom
 
T94-0053793-0/2/1 20-Aug-2010 78ODG 3008456969 Vimed Systems Korea, Republic Of (South)
 
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