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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
853-0525488-1/8/1 05-Jul-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525502-9/7/1 05-Jul-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525506-0/15/1 05-Jul-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525509-4/14/1 05-Jul-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525521-9/14/1 05-Jul-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525521-9/12/1 05-Jul-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525589-6/21/1 05-Jul-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0523882-7/20/1 07-Jul-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0523882-7/21/1 07-Jul-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525465-9/16/1 07-Jul-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525490-7/15/1 07-Jul-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525514-4/14/1 07-Jul-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525553-2/8/1 07-Jul-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
XXX-0184016-5/1/4 13-Jul-2011 78FHQ 3004858808 B D United States
 
AEK-8800988-7/1/3 28-Jul-2011 78FHQ 3374 Hilbro (PVT) Ltd. Pakistan
 
FR1-0013882-0/1/1 15-Jul-2011 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0013805-1/1/1 19-Jul-2011 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0013906-7/2/1 28-Jul-2011 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
004-5585084-2/2/1 11-Jul-2011 78FJK 3002806727 Gambro Renal Products S.A. de C.V. Mexico
 
004-5633738-5/2/1 11-Jul-2011 78FJK 3002806727 Gambro Renal Products S.A. de C.V. Mexico
 
FR1-0013901-8/2/1 18-Jul-2011 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
FR1-0013901-8/1/1 18-Jul-2011 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
853-0525506-0/13/1 05-Jul-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525506-0/14/1 05-Jul-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525509-4/10/1 05-Jul-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525521-9/13/1 05-Jul-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525581-3/23/1 05-Jul-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525581-3/24/1 05-Jul-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0523871-0/23/1 07-Jul-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0523871-0/24/1 07-Jul-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0523882-7/22/1 07-Jul-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0523882-7/23/1 07-Jul-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0523882-7/24/1 07-Jul-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0523882-7/25/1 07-Jul-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0523897-5/10/1 07-Jul-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0523897-5/8/1 07-Jul-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0523897-5/7/1 07-Jul-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0523897-5/9/1 07-Jul-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525465-9/12/1 07-Jul-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525465-9/13/1 07-Jul-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525465-9/14/1 07-Jul-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525481-6/15/1 07-Jul-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525553-2/10/1 07-Jul-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525553-2/9/1 07-Jul-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
231-0781160-0/1/2 26-Jul-2011 78FSH 3008673406 Carefusion Dominican Republic
 
AEK-8464611-2/1/1 21-Jul-2011 78GCI 3007305971 Huger Endoscopy Instruments Co Ltd China
 
112-2697497-5/1/1 12-Jul-2011 78KNW 3004028778 Dixons Surgical Instruments Ltd. United Kingdom
 
231-0780761-6/1/2 26-Jul-2011 78KNW 3008673406 Carefusion Dominican Republic
 
231-0780761-6/1/6 26-Jul-2011 78KNW 3008673406 Carefusion Dominican Republic
 
231-0781160-0/1/1 26-Jul-2011 78KNW 3008673406 Carefusion Dominican Republic
 
853-7400162-7/4/1 15-Jul-2011 78KOG 3007699066 AVAILMED S.A. DE C.V. (MEXICO) Mexico
 
UPS-2522581-0/1/1 05-Jul-2011 78NHU 3008958433 Danamedic Denmark
 
UPS-2889067-7/1/1 15-Jul-2011 78NHU 3008958433 Danamedic Denmark
 
112-6315502-4/1/1 27-Jul-2011 78NHU 3008182617 Danamedic Aps Denmark
 
F23-9042558-5/1/1 07-Jul-2011 78NTZ 2939301 Lifescan Inc United States
 
MR4-1004758-0/2/1 01-Jul-2011 78NZU 3008938656 Bridget Lifescience Co Ltd Korea, Republic Of (South)
 
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