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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
799-0929239-7/1/1 15-Nov-2013 78FHQ 3003862567 American Dental Systems Germany
 
799-0898857-3/1/1 01-Nov-2013 78FHX 3003040625 DeRoyal Industries Inc United States
 
FR1-0015264-9/2/1 13-Nov-2013 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0015309-2/2/1 21-Nov-2013 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
799-1286492-7/1/1 15-Nov-2013 78FJS 3009211636 COVIDIEN MANUFACTURING SOLUTIONS SA Costa Rica
 
799-0838757-8/1/1 08-Nov-2013 78FKH 3006213342 Ibp Medical Germany
 
FR1-0015308-4/2/1 13-Nov-2013 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
FR1-0015308-4/1/1 13-Nov-2013 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
AEK-1140231-6/8/2 29-Nov-2013 78GBM 3010443163 Agrncia Maritima Nabsa Sa Argentina
 
799-1234091-0/1/1 22-Nov-2013 78KNW 3004028778 Dixons Surgical Instruments Ltd. United Kingdom
 
799-1329105-4/1/1 08-Nov-2013 78LKY 3009608482 Bathmate Direct United Kingdom
 
799-1298032-7/1/1 08-Nov-2013 78LKY 3009608482 Bathmate Direct United Kingdom
 
799-1298032-7/2/1 08-Nov-2013 78LKY 3009608482 Bathmate Direct United Kingdom
 
799-0929868-3/1/1 15-Nov-2013 78LKY 3009608482 Bathmate Direct United Kingdom
 
799-0944924-5/2/1 15-Nov-2013 78LKY 3010392762 Penholm-Tillburn United Kingdom
 
799-1016580-6/1/1 19-Nov-2013 78LKY 3009510223 Um Products Ltd United Kingdom
 
799-1203656-7/1/2 29-Nov-2013 78LKY 1000255046 Doc Johnson Enterprises United States
 
799-1203656-7/1/4 29-Nov-2013 78LKY 3003114623 Phsi Inc. United States
 
799-1203656-7/2/1 29-Nov-2013 78LKY 3009225587 Orion Wholesale Germany
 
AEK-7837573-6/1/1 29-Nov-2013 78MRE 3010154739 Shanghai Ums Co Ltd China
 
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