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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
112-8908146-8/1/2 22-Mar-2011 78FAC 3003224128 Sigmacon Impex Limited United Kingdom
 
112-8908146-8/1/8 22-Mar-2011 78FCG 3003224128 Sigmacon Impex Limited United Kingdom
 
112-8908146-8/1/7 22-Mar-2011 78FGM 3003224128 Sigmacon Impex Limited United Kingdom
 
112-8908146-8/1/5 22-Mar-2011 78FHB 3003224128 Sigmacon Impex Limited United Kingdom
 
AEK-8667630-7/1/4 18-Mar-2011 78FHQ 3008797416 Abro International Pakistan
 
112-8908146-8/1/1 22-Mar-2011 78FIQ 3003224128 Sigmacon Impex Limited United Kingdom
 
FR1-0013729-3/4/1 04-Mar-2011 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0013731-9/1/1 04-Mar-2011 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
004-5501112-2/3/1 02-Mar-2011 78FJK 3002806727 Gambro Renal Products S.A. de C.V. Mexico
 
112-8908146-8/1/4 22-Mar-2011 78FKJ 3003224128 Sigmacon Impex Limited United Kingdom
 
FR1-0013729-3/1/1 04-Mar-2011 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0013729-3/2/1 04-Mar-2011 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
112-8908146-8/1/6 22-Mar-2011 78GDS 3003224128 Sigmacon Impex Limited United Kingdom
 
112-8908146-8/1/3 22-Mar-2011 78KGD 3003224128 Sigmacon Impex Limited United Kingdom
 
112-0887487-0/1/1 04-Mar-2011 78KOG 3006688431 Indo Us Mimo Tec Pvt India
 
112-6278593-8/1/1 15-Mar-2011 78LKY 3008182617 Danamedic Aps Denmark
 
315-7448131-8/3/1 14-Mar-2011 78MNV 3006125765 Uritest Medical Electronics Co Ltd China
 
UPS-0432266-1/1/1 07-Mar-2011 78MRE 3004172696 C.L.R. Medicals International, Inc. United States
 
112-6320784-1/1/1 09-Mar-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6056958-1/1/1 15-Mar-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6327418-9/1/1 15-Mar-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6284993-2/1/1 15-Mar-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6285039-3/1/1 15-Mar-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6315595-8/1/1 15-Mar-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6315446-4/1/1 15-Mar-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6282980-1/1/1 15-Mar-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6043594-0/1/1 16-Mar-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6360821-2/1/1 16-Mar-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6360998-8/1/1 16-Mar-2011 78NHU 3008242457 June Vestergaard Denmark
 
112-6360872-5/1/1 16-Mar-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6361229-7/1/1 16-Mar-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6360384-1/1/1 16-Mar-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6361420-2/1/1 16-Mar-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6315548-7/1/1 16-Mar-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6312769-2/1/1 16-Mar-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6360597-8/1/1 16-Mar-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6423243-4/1/1 16-Mar-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6423344-0/1/1 16-Mar-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6327572-3/1/1 16-Mar-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6327809-9/1/1 16-Mar-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6330697-3/1/1 16-Mar-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6389712-0/1/1 16-Mar-2011 78NHU 3008242457 June Vestergaard Denmark
 
112-6423528-8/1/1 16-Mar-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6424123-7/1/1 16-Mar-2011 78NHU 3008182617 Danamedic Aps Denmark
 
DSV-3001797-1/1/1 23-Mar-2011 78NYJ 3008450614 Yantai Hui Xin San Chuang Electronic Co., Ltd China
 
112-8908146-8/1/9 22-Mar-2011 78OCZ 3003224128 Sigmacon Impex Limited United Kingdom
 
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