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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 80-General Hospital/Personal Use


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
MH9-0080071-4/1/1 09-Mar-2010 80FLE 3007138511 Shandong Xinhua Medical Instrument Co Ltd China
 
U35-0470258-0/1/1 20-Mar-2010 80FLE 3005949215 Kordon Tip Saglik Arac Ve Gerrecleri Ltd. Turkey
 
FR1-0013082-7/1/1 01-Mar-2010 80FMF 3003528643 Shanghai Kindly Enterprise Group Co. China
 
MH9-0080613-3/2/1 25-Mar-2010 80FMT 3003307657 Ningbo David Medical Device Co.,Ltd China
 
MH9-0080613-3/1/1 25-Mar-2010 80FMZ 3003307657 Ningbo David Medical Device Co.,Ltd China
 
MH9-0080613-3/3/1 25-Mar-2010 80FNL 3003307657 Ningbo David Medical Device Co.,Ltd China
 
K51-0068523-6/1/1 01-Mar-2010 80FOS 3002808465 Vygon, S.A. France
 
K51-0068523-6/2/1 01-Mar-2010 80FOS 3002808465 Vygon, S.A. France
 
K51-0068523-6/3/1 01-Mar-2010 80FOS 3002808465 Vygon, S.A. France
 
AEK-8009978-7/5/2 13-Mar-2010 80JOK 3007835026 Moonica Fabrics Pakistan
 
788-0711373-0/2/1 23-Mar-2010 80JOL 3004134948 Zhejiang Baite Medical Appliances Co., Ltd. China
 
788-0711373-0/6/1 23-Mar-2010 80JOL 3004134948 Zhejiang Baite Medical Appliances Co., Ltd. China
 
EQ6-0010838-3/1/1 25-Mar-2010 80LDQ 5833 EPPENDORF AG Germany
 
EQ6-0010837-5/1/1 25-Mar-2010 80LDQ 5833 EPPENDORF AG Germany
 
AEK-8009978-7/1/1 13-Mar-2010 80LPZ 3007835026 Moonica Fabrics Pakistan
 
W69-3133112-9/1/1 02-Mar-2010 80LYY 3002808366 TG Medical Sdn Bhd (Factory 3) Malaysia
 
E6T-1000732-5/1/1 16-Mar-2010 80LYY 3006308161 Metacure Surgical Gloves Sdn Bhd Malaysia
 
E6T-1000732-5/1/2 16-Mar-2010 80LYY 3008118614 Ssn Gloves (M) Sdn Bhd Malaysia
 
401-2246730-7/1/1 25-Mar-2010 80LYY 3183 Marcon Rubber Industry Malaysia
 
E41-0064156-9/1/1 10-Mar-2010 80LYZ 3008054685 Shijiazhuang Elegance Plastic Produ China
 
TJE-0912130-2/1/1 16-Mar-2010 80LYZ 3004215883 Baoding Guanzhong Glove Co., Ltd. China
 
E41-0064646-9/1/1/B 18-Mar-2010 80LYZ 3007700594 Shijiazhuang Benestar Plastic Co., China
 
525-0776822-5/1/1 24-Mar-2010 80LYZ 3007332671 Zenith Industries Co.,Ltd. China
 
525-0776908-2/1/1 01-Mar-2010 80LZA 3002955419 Pt Medisafe Technologies Indonesia
 
AEK-9630006-2/1/1 17-Mar-2010 80LZA 1000153953 Laglove Sdn Bhd (M) aka LA Glove Malaysia
 
416-0111484-0/2/1 17-Mar-2010 80LZB 3003245996 Valentine International Ltd. Taiwan
 
AEK-9634495-3/1/1 17-Mar-2010 80LZG 3005171004 Smiths Medical Australia Pty Ltd Australia
 
FR1-0013125-4/4/1 09-Mar-2010 80MEB 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0013125-4/3/1 09-Mar-2010 80MEB 3006471098 Daiken Medical Co. Ltd. Japan
 
HG4-0015793-6/2/1 03-Mar-2010 80NPC 3002327142 Zhenjiang Kangda Emulsion Co,Ltd China
 
HG4-0015793-6/3/1 03-Mar-2010 80NPC 3002327142 Zhenjiang Kangda Emulsion Co,Ltd China
 
HG4-0015793-6/4/1 03-Mar-2010 80NPC 3002327142 Zhenjiang Kangda Emulsion Co,Ltd China
 
HG4-0015793-6/1/1 03-Mar-2010 80NPC 3002327142 Zhenjiang Kangda Emulsion Co,Ltd China
 
N81-0112872-4/1/1/B 15-Mar-2010 80NPC 3003849748 Shanghai ChinaStar Corporation China
 
109-0795644-4/1/1/B 31-Mar-2010 80NPC 3003699698 Maxter Glove Manufacturing Sdn Bhd Malaysia
 
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