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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
112-2449419-0/5/7 04-Jun-2012 78EXB 3008939517 Shree Umiya Surgical India
 
112-5448560-4/1/1 20-Jun-2012 78EXG 3002814991 Bard Canada
 
112-9909744-8/1/1 01-Jun-2012 78EYQ 3000958172 Lambi, S.A. De C.V. Mexico
 
112-7760811-7/1/6 11-Jun-2012 78EYT 3006992278 Surgimedik Healthcare India
 
112-3890183-4/1/1 04-Jun-2012 78FAE 3009108635 Peecock Products (Singapore Singapore
 
112-6365586-6/1/2 18-Jun-2012 78FAJ 3000236545 Olympus Optical Co., Ltd. Japan
 
BJV-0244518-8/42/11 21-Jun-2012 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0244654-1/48/18 21-Jun-2012 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0245198-8/34/14 27-Jun-2012 78FDE 3004710519 Convertors De Mexico Mexico
 
112-7792872-2/1/1 20-Jun-2012 78FFX 1000540736 Mui Scientific Canada
 
112-6519260-3/1/1 19-Jun-2012 78FGA 3005279262 Crimo France France
 
112-2006928-5/2/2 04-Jun-2012 78FHQ 3008654218 Ksg Surgical Pakistan
 
FR1-0014445-5/1/1 05-Jun-2012 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0014445-5/2/1 05-Jun-2012 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
112-2449419-0/5/6 04-Jun-2012 78FPD 3008939517 Shree Umiya Surgical India
 
112-2449419-0/5/5 04-Jun-2012 78FPD 3008939517 Shree Umiya Surgical India
 
UPS-4912964-2/1/1 20-Jun-2012 78FPD 3008764968 Iti Company (Shanghai) Ltd. China
 
112-9786430-2/1/1 01-Jun-2012 78GCI 3008625472 Lister Surgical Co Pakistan
 
112-6365586-6/2/1 18-Jun-2012 78GCI 3004890986 Machida Inc United States
 
112-6365586-6/1/1 18-Jun-2012 78GCI 3000236545 Olympus Optical Co., Ltd. Japan
 
112-2449419-0/5/2 04-Jun-2012 78KGC 3008939517 Shree Umiya Surgical India
 
112-2449419-0/5/4 04-Jun-2012 78KGC 3008939517 Shree Umiya Surgical India
 
112-2449419-0/5/3 04-Jun-2012 78KGC 3008939517 Shree Umiya Surgical India
 
112-6823448-5/1/1 20-Jun-2012 78KNT 3002806934 Kendall Company L.P. Mexico
 
112-6823448-5/1/3 20-Jun-2012 78KNT 3002806934 Kendall Company L.P. Mexico
 
112-5556974-5/1/1 20-Jun-2012 78KNW 3005727876 Cormedica France
 
112-6774828-7/1/1 18-Jun-2012 78KNY 3002807439 Lake Region Medical, Ltd. Ireland
 
112-7232343-1/1/1 08-Jun-2012 78KOA 3007335364 MEDICAM INC. Canada
 
112-7760811-7/1/1 11-Jun-2012 78KOE 3006992278 Surgimedik Healthcare India
 
112-7094109-3/1/1 08-Jun-2012 78KOG 3007291400 Original Manufactured Endoscopes Germany
 
112-7760811-7/1/5 11-Jun-2012 78LJE 3006992278 Surgimedik Healthcare India
 
112-7222868-9/1/1 20-Jun-2012 78LKX 1000337533 Polyverb Industrial Co Ltd. Taiwan
 
112-6596863-1/1/1 01-Jun-2012 78LKY 3006891790 ANDROMEDICAL SL Spain
 
112-7803588-1/1/1 05-Jun-2012 78LKY 3009542716 Shenyang College Of Import/Exoort China
 
112-5677115-0/1/1 15-Jun-2012 78LKY 3009314442 Amfah International Pakistan
 
EG6-2649492-6/5/1 29-Jun-2012 78LKY 3008247701 Lubecki Technical Holdings, Inc. Canada
 
112-6615169-9/1/1 20-Jun-2012 78LOA 3009937642 Meko Germany
 
112-6834933-3/1/2 20-Jun-2012 78MSD 3008269645 Sherwood Medical Co United States
 
112-1898578-1/1/1 07-Jun-2012 78NHU 3008182617 Danamedic Aps Denmark
 
112-1898726-6/1/1 07-Jun-2012 78NHU 3008182617 Danamedic Aps Denmark
 
112-6016935-8/1/1 18-Jun-2012 78NHU 3008182617 Danamedic Aps Denmark
 
112-5624286-2/1/1 19-Jun-2012 78NHU 3005401991 Danamedic Aps Denmark
 
112-6523537-8/1/1 19-Jun-2012 78NHU 3008242457 June Vestergaard Denmark
 
112-6979438-8/1/1 20-Jun-2012 78NHU 3008182617 Danamedic Aps Denmark
 
UPS-1129843-2/1/1 12-Jun-2012 78OCS 3002808445 Accellent Juarez Mexico
 
112-7760811-7/1/3 11-Jun-2012 78OCY 3006992278 Surgimedik Healthcare India
 
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