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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 79-General & Plastic Surgery


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
406-0493285-1/8/6 15-Aug-2013 79BTA 3003211413 Hersill, S.L. Spain
 
AZE-0062128-9/3/1 13-Aug-2013 79FMK 3003096921 Qingdao Shuang China
 
AZE-0062128-9/7/1 13-Aug-2013 79FMK 3008876079 Qingdao Mingruixing Trading Co China
 
AZE-0062153-7/5/1 13-Aug-2013 79FMK 3003096921 Qingdao Shuang China
 
AZE-0062153-7/8/1 13-Aug-2013 79FMK 3008876079 Qingdao Mingruixing Trading Co China
 
AZE-0062192-5/3/1 13-Aug-2013 79FMK 3003096921 Qingdao Shuang China
 
AZE-0062192-5/7/1 13-Aug-2013 79FMK 3008876079 Qingdao Mingruixing Trading Co China
 
UPS-8151908-7/2/1 21-Aug-2013 79GAS 3004019700 Ethicon Inc United States
 
336-9457844-8/1/1 15-Aug-2013 79GCJ 3006581049 Microtek Medical Malta Limited Malta & Gozo
 
336-9457844-8/1/2 15-Aug-2013 79GCJ 3006581049 Microtek Medical Malta Limited Malta & Gozo
 
406-0493285-1/8/7 15-Aug-2013 79GCY 3003211413 Hersill, S.L. Spain
 
MH9-2016237-6/1/1 13-Aug-2013 79GEI 3004448018 Daiwha Corporation, Ltd Korea, Republic Of (South)
 
BJY-0711414-1/1/1 26-Aug-2013 79GEI 3009674567 Wem Equipamentos Electronicos Ltda Brazil
 
AEK-9325365-2/1/1 16-Aug-2013 79GEX 3009786814 Wuhan Gigaa Optronics China
 
AEK-9193370-1/1/1 26-Aug-2013 79GEX 3008476006 Laseroptek Co. Ltd. Korea, Republic Of (South)
 
336-9554990-1/8/1 30-Aug-2013 79HAB 3009027753 Zimmer Surgical Sa Switzerland
 
336-9554990-1/7/1 30-Aug-2013 79HAB 3009027753 Zimmer Surgical Sa Switzerland
 
UPS-1753466-2/1/1 12-Aug-2013 79HXD 3009271861 4dimens Aps Denmark
 
WX5-0184934-2/10/1 16-Aug-2013 79KGX 3002750084 Aspen Surgical Products, Inc. United States
 
279-4174946-0/7/1 01-Aug-2013 79LRR 3005205809 Yuan Huang Enterprise Co Ltd Taiwan
 
F57-9129942-6/13/1 06-Aug-2013 79LRR 3000136785 Superex Canada Ltd Canada
 
F57-9124154-3/17/1 06-Aug-2013 79LRR 3000136785 Superex Canada Ltd Canada
 
F57-9130045-5/1/1 26-Aug-2013 79LRR 3000136785 Superex Canada Ltd Canada
 
F57-9143257-1/4/1 29-Aug-2013 79LRR 3000136785 Superex Canada Ltd Canada
 
F57-9143257-1/11/1 29-Aug-2013 79LRR 3000136785 Superex Canada Ltd Canada
 
406-0493285-1/2/1 15-Aug-2013 79MDA 3010307616 Fenin Spain
 
112-3533658-9/1/1 06-Aug-2013 79MDM 3010266697 Bruker Nano Gmbh Germany
 
336-9554990-1/3/1 30-Aug-2013 79MOQ 3009027753 Zimmer Surgical Sa Switzerland
 
336-9554990-1/5/1 30-Aug-2013 79MOQ 3009027753 Zimmer Surgical Sa Switzerland
 
M50-0281400-7/1/1 09-Aug-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
HG8-0142874-6/2/1 30-Aug-2013 79NAY 3010293704 Inversiones Drilltex Sas Colombia
 
799-0180375-3/5/1 01-Aug-2013 79NEC 3007237787 Snugz Usa United States
 
336-9461199-1/1/1 06-Aug-2013 79NUV 3003772750 Syneron Medical Ltd. Israel
 
575-0300442-6/1/1 20-Aug-2013 79OHO 3005709924 Zodiac International France
 
112-3405951-3/1/1 08-Aug-2013 79ONQ 3010260402 Gd Beauty Company China
 
112-3405951-3/1/2 08-Aug-2013 79ONQ 3010260402 Gd Beauty Company China
 
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