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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
279-9819126-9/12/1 20-Feb-2013 79EFQ 3005552103 Allmed Medical Products Co Ltd. (Shenzen Factory) China
 
279-9819126-9/13/1 20-Feb-2013 79EFQ 3005552103 Allmed Medical Products Co Ltd. (Shenzen Factory) China
 
279-9819126-9/15/1 20-Feb-2013 79EFQ 3005552103 Allmed Medical Products Co Ltd. (Shenzen Factory) China
 
279-9819126-9/22/1 20-Feb-2013 79EFQ 3005552103 Allmed Medical Products Co Ltd. (Shenzen Factory) China
 
279-9819126-9/25/1 20-Feb-2013 79EFQ 3005552103 Allmed Medical Products Co Ltd. (Shenzen Factory) China
 
279-9819126-9/31/1 20-Feb-2013 79EFQ 3005552103 Allmed Medical Products Co Ltd. (Shenzen Factory) China
 
279-9936870-0/18/1 22-Feb-2013 79EFQ 3004130013 Allmed Medical Products Co., Ltd. (Dong Guan Factory) China
 
279-9936870-0/17/1 22-Feb-2013 79EFQ 3004130013 Allmed Medical Products Co., Ltd. (Dong Guan Factory) China
 
279-9936870-0/14/1 22-Feb-2013 79EFQ 3004130013 Allmed Medical Products Co., Ltd. (Dong Guan Factory) China
 
279-9936870-0/4/1 22-Feb-2013 79EFQ 3004130013 Allmed Medical Products Co., Ltd. (Dong Guan Factory) China
 
279-9937035-9/14/1 26-Feb-2013 79EFQ 3004130013 Allmed Medical Products Co., Ltd. (Dong Guan Factory) China
 
AEK-0774414-3/1/1 13-Feb-2013 79GAK 3007084575 Shandong Weigao Group Medical Polymer Co., Ltd. China
 
610-8705343-7/1/1 21-Feb-2013 79GBX 3003135068 Modern Medical Equipment Manufacturing Ltd Hong Kong SAR
 
279-9819126-9/11/1 20-Feb-2013 79GDY 3005552103 Allmed Medical Products Co Ltd. (Shenzen Factory) China
 
279-9819126-9/26/1 20-Feb-2013 79GDY 3005552103 Allmed Medical Products Co Ltd. (Shenzen Factory) China
 
BQL-0031957-2/3/2/A 01-Feb-2013 79GEM 3009862101 pkf razuitive Russia
 
BQL-0031957-2/3/2/B 01-Feb-2013 79GEM 3009862106 Ahtamar LLC Russia
 
BQL-0031957-2/3/2/D 01-Feb-2013 79GEM 3009862101 pkf razuitive Russia
 
BQL-0031957-2/3/2/H 01-Feb-2013 79GEM 3005597802 Unknown Russia
 
H77-0133776-5/1/1 28-Feb-2013 79GEN 3002808010 Rkz Surgical (Pvt), Ltd. Pakistan
 
AEK-0758766-6/2/1 21-Feb-2013 79GEX 3010009404 Zheijinag Lasy Science and Technology Co. Ltd China
 
112-1368349-9/1/1 28-Feb-2013 79GFE 3008688709 East West Industries Vietnam LLC Vietnam
 
112-0576868-8/2/7 01-Feb-2013 79HTD 3005270144 Biotech International France
 
112-0576868-8/2/13 01-Feb-2013 79HTD 3005270144 Biotech International France
 
112-1388908-8/2/1 01-Feb-2013 79HTD 3009989920 Frontier Medical Group United Kingdom
 
112-0576868-8/2/1 01-Feb-2013 79HTR 3005270144 Biotech International France
 
112-0576868-8/2/8 01-Feb-2013 79HTR 3005270144 Biotech International France
 
112-0576868-8/2/10 01-Feb-2013 79HTR 3005270144 Biotech International France
 
112-0576868-8/2/9 01-Feb-2013 79HTR 3005270144 Biotech International France
 
112-0576868-8/2/3 01-Feb-2013 79HTR 3005270144 Biotech International France
 
112-0576868-8/2/2 01-Feb-2013 79HTR 3005270144 Biotech International France
 
112-0576868-8/2/11 01-Feb-2013 79HXD 3005270144 Biotech International France
 
112-0576868-8/2/4 01-Feb-2013 79HXD 3005270144 Biotech International France
 
A28-2000184-5/1/1 04-Feb-2013 79KKX 3009958851 Metset Saglik Urunleri San Ve Tic Ltd Sti Turkey
 
BUK-0125993-4/64/1 04-Feb-2013 79LRR 7335 W. Sohngen Gmbh Germany
 
HQ7-0044315-8/1/1 01-Feb-2013 79MDM 3009975459 Nova Spine Sarl France
 
112-9547761-1/1/1 04-Feb-2013 79MDM 3002807988 Reda Instrumente Gmbh Germany
 
H77-0133776-5/1/2 28-Feb-2013 79MDM 3002808010 Rkz Surgical (Pvt), Ltd. Pakistan
 
EQW-0006863-7/1/1 14-Feb-2013 79MFG 3009963964 Virocana Group Inc United States
 
UPS-9368220-7/1/1/A 19-Feb-2013 79MWZ 3009984162 Cnt 0724ay Plus Develpment Hk Co Lt Hong Kong SAR
 
UPS-1198058-3/24/2 08-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
UPS-1198059-1/9/2 08-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
UPS-1198068-2/13/2 08-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
UPS-1198068-2/20/2 08-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008511-6/11/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008511-6/10/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008511-6/9/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008511-6/12/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008511-6/14/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008511-6/13/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008511-6/15/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008511-6/16/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008511-6/18/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008511-6/17/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008439-0/8/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008439-0/9/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008439-0/13/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008701-3/1/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008701-3/3/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008701-3/4/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008701-3/5/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008701-3/6/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008701-3/2/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008701-3/12/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/1/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/12/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/14/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/25/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/34/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/35/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/11/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/19/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/23/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/10/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/43/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/37/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/27/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/29/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/26/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/20/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/18/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/13/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/31/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/33/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/6/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/7/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/5/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/3/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/2/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/28/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/8/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/44/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/15/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/16/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/17/1 12-Feb-2013 79NAB 3005552103 Allmed Medical Products Co Ltd. (Shenzen Factory) China
 
97Y-0008409-3/36/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/4/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/9/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/21/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/32/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/30/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/24/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008409-3/22/1 12-Feb-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
UPS-9368220-7/1/1/B 19-Feb-2013 79NRJ 3009984162 Cnt 0724ay Plus Develpment Hk Co Lt Hong Kong SAR
 
E7E-5000294-3/1/1 28-Feb-2013 79OAP 3008616050 Shenzhen Bless Electronic Techno China
 
988-0252321-1/1/1 22-Feb-2013 79ONE 3002934381 Continuum Biomedical Inc. United States
 
UPS-9424986-5/1/6 06-Feb-2013 79ONQ 3003686094 SERP Societe D'Etudes Et De Recherc France
 
AEK-0827276-3/1/1 21-Feb-2013 79OYW 3009052317 Mychway Co. Ltd. China
 
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