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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
FR1-0014725-0/1/1 10-Dec-2012 80BRZ 3003238685 Shanghai Amsino Medical Devices Co., Ltd. China
 
BPQ-5005240-1/1/1 17-Dec-2012 80FLE 3005343391 Tuttnauer Ltd Israel
 
EJ2-0108730-4/17/3 26-Dec-2012 80FLL 3009764393 Shenzhen Tomtop Technology Co. Ltd. China
 
EJ2-0108730-4/17/1 26-Dec-2012 80FLL 3009764393 Shenzhen Tomtop Technology Co. Ltd. China
 
EJ2-0108730-4/17/2 26-Dec-2012 80FLL 3009764393 Shenzhen Tomtop Technology Co. Ltd. China
 
853-7469801-8/95/1 19-Dec-2012 80FMG 3005519694 Icu Medical De Mexico S.A. De C.V. Mexico
 
551-0432296-7/3/1 03-Dec-2012 80FQM 3005052406 Chain Medical Products Co., Ltd. China
 
551-0432296-7/2/1 03-Dec-2012 80FQM 3005052406 Chain Medical Products Co., Ltd. China
 
551-0432296-7/1/1 03-Dec-2012 80FQM 3005052406 Chain Medical Products Co., Ltd. China
 
NV3-0052198-0/2/1 19-Dec-2012 80FQM 3009596709 Anji Hengfeng Sanitary Material China
 
NV3-0052198-0/1/1 19-Dec-2012 80FQM 3009596709 Anji Hengfeng Sanitary Material China
 
NV3-0052198-0/3/1 19-Dec-2012 80FQM 3009596709 Anji Hengfeng Sanitary Material China
 
112-0039774-9/1/1 07-Dec-2012 80FRN 3009810407 Arcomed Ag Switzerland
 
AYO-0017232-6/1/1 21-Dec-2012 80FRN 3003513491 Viltechmeda UAB Lithuania
 
FR1-0014766-4/2/1 24-Dec-2012 80FRN 3007482089 Miyuki Elex Co.,Ltd Japan
 
MH9-2006226-1/1/1 10-Dec-2012 80KMH 3007138511 Shandong Xinhua Medical Instrument Co Ltd China
 
MH9-2006225-3/1/1 12-Dec-2012 80KMH 3007138511 Shandong Xinhua Medical Instrument Co Ltd China
 
112-0255621-9/1/1 13-Dec-2012 80KYS 3009769211 Currex Gmbh Germany
 
AEK-0317039-2/1/1 18-Dec-2012 80LNX 3006482880 Actreg (U.K.) Ltd. United Kingdom
 
EJG-0230418-2/4/1 20-Dec-2012 80LYY 3009740102 Kallum Beuty Care Co. Ltd China
 
113-5723971-1/1/1 17-Dec-2012 80LZA 3002327142 Zhenjiang Kangda Emulsion Co,Ltd China
 
BMB-0010867-8/1/1 05-Dec-2012 80MIA 3009881252 Nanjing Kaihong Healthcare Co Ltd China
 
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