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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
FR1-0014943-9/1/1 01-Mar-2013 78EZL 3010040929 Cardionovum Gmbh Germany
 
FR1-0014943-9/2/1 01-Mar-2013 78EZL 3010040924 Cardionovum Sp. Zo.O Poland
 
UPS-9435189-3/1/1 06-Mar-2013 78FAJ 3007650281 Freelance Surgical Ltd United Kingdom
 
112-1799309-2/1/1 22-Mar-2013 78FBK 3009102954 Medi-Globe Czech Republic
 
112-1799309-2/1/3 22-Mar-2013 78FBK 3009102954 Medi-Globe Czech Republic
 
KH5-0081414-1/26/1/B 07-Mar-2013 78FCE 1000244108 Unknown China
 
112-1799309-2/1/4 22-Mar-2013 78FCG 3009102954 Medi-Globe Czech Republic
 
112-1799309-2/1/2 22-Mar-2013 78FDI 3009102954 Medi-Globe Czech Republic
 
FR1-0014894-4/1/1 05-Mar-2013 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0014894-4/2/1 05-Mar-2013 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
FR1-0014901-7/2/1 29-Mar-2013 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
FR1-0014901-7/1/1 29-Mar-2013 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
112-1896771-5/1/1 29-Mar-2013 78KOG 3007222774 Olympus Corporatio Japan
 
MC2-6373230-7/1/1 06-Mar-2013 78NCV 3010056222 Engemed Industria Comercio Brazil
 
112-1682839-8/1/1 22-Mar-2013 78NHU 3005615971 ORBISAN LTD Malta & Gozo
 
112-1941371-9/1/1 29-Mar-2013 78NHU 3009762300 UM Products Ltd United Kingdom
 
112-1941371-9/2/1 29-Mar-2013 78NHU 3009762300 UM Products Ltd United Kingdom
 
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