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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
406-0493215-8/8/6 13-Sep-2013 79BTA 3003211413 Hersill, S.L. Spain
 
799-0532079-6/1/1 04-Sep-2013 79DWG 3009100782 Thoratec Switzerland Gmbh Switzerland
 
799-0532079-6/1/2 04-Sep-2013 79DWG 3009100782 Thoratec Switzerland Gmbh Switzerland
 
799-0532079-6/2/1 04-Sep-2013 79DWG 3009100782 Thoratec Switzerland Gmbh Switzerland
 
H77-0137030-3/1/13 18-Sep-2013 79FTY 3001340284 Pleasant Surgico Pakistan
 
H77-0137030-3/1/10 18-Sep-2013 79FTY 3001340284 Pleasant Surgico Pakistan
 
AMN-0021223-9/3/1 25-Sep-2013 79FXX 3010385393 Goshen International Logistics China
 
406-0493215-8/8/7 13-Sep-2013 79GCY 3003211413 Hersill, S.L. Spain
 
799-0533300-5/1/1 23-Sep-2013 79GEI 3005509295 Insightec Image Gu Israel
 
799-0533300-5/2/1 23-Sep-2013 79GEI 3010343867 Cdw United States
 
799-0533300-5/2/2 23-Sep-2013 79GEI 3010343866 Allied Electronics United States
 
799-0533300-5/3/1 23-Sep-2013 79GEI 3010343865 M-Security Technology Sdn Bhd Malaysia
 
112-3664555-8/1/1 05-Sep-2013 79GES 3003862567 American Dental Systems Germany
 
799-0426862-4/1/1 06-Sep-2013 79GES 3003195452 Surgi Edge (India) India
 
H77-0137030-3/1/23 18-Sep-2013 79GES 3001340284 Pleasant Surgico Pakistan
 
AEK-7750603-4/1/1 11-Sep-2013 79GEX 3009786814 Wuhan Gigaa Optronics China
 
799-0503933-9/1/1 26-Sep-2013 79GEX 3002790438 Dilas Diodenlaser Gmbh Germany
 
UPS-1905673-0/1/1 05-Sep-2013 79HTD 3006386489 S Murray & Co United Kingdom
 
H77-0137030-3/1/16 18-Sep-2013 79HTD 3001340284 Pleasant Surgico Pakistan
 
H77-0137030-3/1/3 18-Sep-2013 79HTD 3001340284 Pleasant Surgico Pakistan
 
H77-0137030-3/1/15 18-Sep-2013 79HTD 3001340284 Pleasant Surgico Pakistan
 
H77-0137030-3/1/4 18-Sep-2013 79HTD 3001340284 Pleasant Surgico Pakistan
 
H77-0137030-3/1/1 18-Sep-2013 79HTD 3001340284 Pleasant Surgico Pakistan
 
WX5-0181503-8/6/2 10-Sep-2013 79KGX 3002750084 Aspen Surgical Products, Inc. United States
 
609-0328347-5/1/1 19-Sep-2013 79KGX 3006256586 3m Company United States
 
551-2414326-0/1/1 16-Sep-2013 79LRR 3010357156 Dsi Safety Inc Canada
 
799-0831695-7/21/1 17-Sep-2013 79LRR 3010377259 Sun Med China
 
406-0493215-8/2/1 13-Sep-2013 79MDA 3010307616 Fenin Spain
 
799-0468294-9/1/1 13-Sep-2013 79MDM 3007361698 DERMAROLLER GMBH Germany
 
H77-0137030-3/1/6 18-Sep-2013 79MDM 3001340284 Pleasant Surgico Pakistan
 
799-0421503-9/1/1 06-Sep-2013 79MDW 3010330553 Gvs Filter Technology Uk Ltd United Kingdom
 
97Y-0008312-9/1/1 18-Sep-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008312-9/2/1 18-Sep-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008312-9/3/1 18-Sep-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008312-9/5/1 18-Sep-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0008312-9/4/1 18-Sep-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0009931-5/1/1 18-Sep-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0009931-5/6/1 18-Sep-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0009931-5/3/1 18-Sep-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0009931-5/4/1 18-Sep-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0009931-5/2/1 18-Sep-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
97Y-0009931-5/5/1 18-Sep-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
609-0328069-5/2/1 04-Sep-2013 79NAD 1049092 Convatec, A Bristol-Myers Squibb Co. United States
 
609-0328069-5/1/1 04-Sep-2013 79NAD 1049092 Convatec, A Bristol-Myers Squibb Co. United States
 
609-0328316-0/1/1 04-Sep-2013 79NAD 1049092 Convatec, A Bristol-Myers Squibb Co. United States
 
XXX-0182182-7/3/180/A 18-Sep-2013 79NRJ 3002087856 SonoSite, Inc. United States
 
XXX-0182182-7/3/180/B 18-Sep-2013 79NRJ 3002087856 SonoSite, Inc. United States
 
UPS-1838116-2/1/1 04-Sep-2013 79OAP 3010316358 Sheps Medical Corp Canada
 
799-0752189-6/1/1 27-Sep-2013 79OHO 1000585474 Air Dynamics Co Ltd Canada
 
AEK-7772741-6/1/1 17-Sep-2013 79OHV 3010380996 Guangzhou T&M Beauty Equipmnt Co Ltd China
 
UPS-2104750-3/1/1 25-Sep-2013 79ONQ 3009802748 Guangzhou Laizhong Electronics Tech Co Ltd China
 
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