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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
KT5-0278876-5/1/1 03-Jun-2013 79EMF 3009082984 Aadpri Ophthalmic Company India
 
UPS-1198110-9/1/1 18-Jun-2013 79FZD 3009271861 4dimens Aps Denmark
 
112-2792991-2/1/1 05-Jun-2013 79GAC 3010103855 Ayuron Implants Pvt Ltd India
 
004-6582944-8/1/1 28-Jun-2013 79GAK 3007467791 Imres B.V. Netherlands
 
004-6582944-8/2/1 28-Jun-2013 79GAK 3007467791 Imres B.V. Netherlands
 
004-6582944-8/3/1 28-Jun-2013 79GAK 3007467791 Imres B.V. Netherlands
 
112-2987122-9/2/1 21-Jun-2013 79GCB 3008456389 Kitazato Medical Co Ltd Japan
 
UPS-1269270-5/1/1 27-Jun-2013 79GEX 3009769082 Sunny Optoelectronic Tech Co.Ltd China
 
UPS-6415539-6/1/1 30-Jun-2013 79GEX 3003168101 LISA Laser Products OHG Germany
 
AEK-9234116-9/1/1 24-Jun-2013 79GFE 3009706548 Daystar Enterprises Ltd China
 
112-2605444-9/2/1 03-Jun-2013 79KGO 3003153579 Cangene Corporation Canada
 
112-2605444-9/6/1 03-Jun-2013 79KGX 3003153579 Cangene Corporation Canada
 
199-0042976-2/1/1 25-Jun-2013 79MIC 3010183775 Shanghai Nhelaine Medical Device Co Ltd China
 
9M3-1005972-3/1/6 10-Jun-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
9M3-1006241-2/53/1 25-Jun-2013 79NAB 3005552103 Allmed Medical Products Co Ltd. (Shenzen Factory) China
 
9M3-1006241-2/55/1 25-Jun-2013 79NAB 3005552103 Allmed Medical Products Co Ltd. (Shenzen Factory) China
 
9M3-1005712-3/1/11 26-Jun-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
9M3-1005712-3/1/9 26-Jun-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
9M3-1005712-3/1/8 26-Jun-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
9M3-1006302-2/2/1 27-Jun-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
9M3-1006302-2/1/1 27-Jun-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
9M3-1006302-2/3/19 27-Jun-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
112-2692661-2/1/1 04-Jun-2013 79OAP 3002992007 Sometech Incorporated Korea, Republic Of (South)
 
112-2899318-0/1/1 10-Jun-2013 79OHV 3010189313 Shenzhen Weike Automation Equipment Co., Ltd China
 
112-2899412-1/1/1 10-Jun-2013 79OHV 3010189313 Shenzhen Weike Automation Equipment Co., Ltd China
 
AL6-0056475-4/1/1 07-Jun-2013 79OLP 3009695558 General Project Srl Italy
 
112-2653031-5/1/1 06-Jun-2013 79ONQ 3009772543 Dongguan City Eastking Handbags Factory China
 
BTF-2028157-8/1/1 30-Jun-2013 79OUH 3009206941 Viol Co Ltd Korea, Republic Of (South)
 
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