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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
322-0076916-8/2/2 19-Aug-2009 78EYB 3007632112 Ms Surgimedk Healthcare India
 
322-0076916-8/2/6 19-Aug-2009 78EZN 3007632112 Ms Surgimedk Healthcare India
 
322-0076916-8/1/1 19-Aug-2009 78FAD 3007632112 Ms Surgimedk Healthcare India
 
112-7317542-5/1/1 26-Aug-2009 78FAE 3007335337 Ultramax Products United Kingdom
 
322-0076916-8/2/8 19-Aug-2009 78FBK 3007632112 Ms Surgimedk Healthcare India
 
XXX-0164178-7/3/2 20-Aug-2009 78FDL 3007637478 Harbin Tiandiren Medical Science and Technology Co., Ltd China
 
322-0076916-8/3/2 19-Aug-2009 78FFL 3007632112 Ms Surgimedk Healthcare India
 
322-0076916-8/1/2 19-Aug-2009 78FGE 3007632112 Ms Surgimedk Healthcare India
 
322-0076916-8/2/7 19-Aug-2009 78FHA 3007632112 Ms Surgimedk Healthcare India
 
112-7262925-7/1/3 26-Aug-2009 78FHQ 3005578139 Richter Ltda-Surgical Instrument Brazil
 
FR1-0012796-3/1/1 14-Aug-2009 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0012640-3/2/1 13-Aug-2009 78FKP 3000247873 Nipro Corporation Japan
 
FR1-0012785-6/1/1 14-Aug-2009 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0012785-6/2/1 14-Aug-2009 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
112-6647617-8/2/1 03-Aug-2009 78GCJ 3002808088 Scholly Fiberoptic Gmbh Germany
 
T94-0050248-8/6/1 13-Aug-2009 78KNT 3005327291 Shanghai Neo-Medical Import & Export Co., Ltd. China
 
322-0076916-8/2/9 19-Aug-2009 78KNT 3007632112 Ms Surgimedk Healthcare India
 
322-0076916-8/3/1 19-Aug-2009 78KNT 3007632112 Ms Surgimedk Healthcare India
 
322-0076916-8/2/3 19-Aug-2009 78KOB 3007632112 Ms Surgimedk Healthcare India
 
322-0076916-8/2/4 19-Aug-2009 78KOD 3007632112 Ms Surgimedk Healthcare India
 
322-0076916-8/2/5 19-Aug-2009 78KOE 3007632112 Ms Surgimedk Healthcare India
 
322-0076916-8/2/11 19-Aug-2009 78KOG 3007632112 Ms Surgimedk Healthcare India
 
322-0076916-8/2/1 19-Aug-2009 78LJE 3007632112 Ms Surgimedk Healthcare India
 
112-6609480-7/1/1 03-Aug-2009 78LJH 3006048886 Ems Medical United Kingdom
 
112-6277299-2/1/1 19-Aug-2009 78LKY 3007335337 Ultramax Products United Kingdom
 
UPS-5527839-2/2/1 25-Aug-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
231-9116160-6/2/1 13-Aug-2009 78MQS 3007688133 Jms North America Corp El Salvador
 
231-9117481-5/2/1 20-Aug-2009 78MQS 3003277330 Ecm Ingenieria S.A. Chile
 
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