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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
BWR-0053222-2/6/1 19-Feb-2014 79FMK 3009385971 Medico Huai An China
 
BWR-0053222-2/3/1 19-Feb-2014 79FMK 3009385971 Medico Huai An China
 
E8F-1321246-1/3/1/C 28-Feb-2014 79FMK 3008157353 East Trading Co Korea, Republic Of (South)
 
799-2391703-7/4/1 04-Feb-2014 79FRO 3010588092 Bsn Medical Supplies United Kingdom
 
799-2391703-7/4/4 04-Feb-2014 79FRO 3010588092 Bsn Medical Supplies United Kingdom
 
799-2391703-7/4/2 04-Feb-2014 79FRO 3010588092 Bsn Medical Supplies United Kingdom
 
799-2391703-7/4/3 04-Feb-2014 79FRO 3010588092 Bsn Medical Supplies United Kingdom
 
UPS-4100695-0/1/1 24-Feb-2014 79FTN 3009271861 4dimens Aps Denmark
 
UPS-3911089-7/1/1 24-Feb-2014 79FTN 3009271861 4dimens Aps Denmark
 
UPS-4366553-0/1/1 27-Feb-2014 79FTN 3009271861 4dimens Aps Denmark
 
799-2095279-7/1/1 07-Feb-2014 79FTR 3003593777 Mentor Medical Sys Netherlands
 
DSV-7001656-0/1/1 28-Feb-2014 79FWY 3010457054 Carina Medical France
 
WGB-1312183-2/6/1 11-Feb-2014 79GDG 3007222337 BAIWANG MANUFACTURING PLANT, SHENZHEN MINDRAY China
 
UPS-4185418-5/1/1 19-Feb-2014 79GDM 3010647521 Guangzhou Zixuan Tattoo and Permanent Makeup China
 
XXX-0180274-9/1/1 11-Feb-2014 79GDY 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
AEK-4519129-9/2/3 03-Feb-2014 79GEA 3010583952 Spiral Surgical Pakistan
 
799-2227422-4/1/1 05-Feb-2014 79GEA 3002731916 Shoney Scientific India India
 
799-2799358-8/1/1 05-Feb-2014 79GED 3010625423 Guangzhou E Kai China
 
799-2799358-8/1/2 05-Feb-2014 79GED 3010625423 Guangzhou E Kai China
 
799-2799358-8/1/3 05-Feb-2014 79GED 3010625423 Guangzhou E Kai China
 
AEK-4519129-9/2/1 03-Feb-2014 79GEG 3010583952 Spiral Surgical Pakistan
 
AEK-4536341-9/1/1 24-Feb-2014 79GEI 3010619478 Yufung Pharmaceuticals Hong Kong SAR
 
UPS-3922338-5/1/1 05-Feb-2014 79GEX 3007567374 Radiancy Israel Israel
 
AEK-1712356-9/1/1 10-Feb-2014 79GFE 3010572682 Perfect Idea China Limited China
 
AEK-4563942-0/1/1 21-Feb-2014 79GFE 3009491199 SUNWOO I&T Korea, Republic Of (South)
 
AEK-4519129-9/2/2 03-Feb-2014 79GFJ 3010583952 Spiral Surgical Pakistan
 
UPS-3589723-2/1/1 04-Feb-2014 79KCW 1000439607 Sterex Electrolysis Int Ltd United Kingdom
 
799-2362253-8/1/2 24-Feb-2014 79KFK 3006011135 Stryker Corporation United States
 
799-2366577-6/2/1 13-Feb-2014 79LRR 1000583521 DME Corporation United States
 
799-2366577-6/3/1 13-Feb-2014 79LRR 1000583521 DME Corporation United States
 
799-2694209-9/1/1 28-Feb-2014 79MDM 3010608454 Gaoyao Jinli Town Qifu Hardware China
 
D68-0069241-3/1/1 06-Feb-2014 79MJG 3002731916 Shoney Scientific India India
 
799-2913375-3/1/1 06-Feb-2014 79OHO 3010630511 Skan International Co Ltd Saudi Arabia
 
EMO-0047890-0/55/1 07-Feb-2014 79OHO 3009480303 Engel Austria Gmbh Austria
 
AEK-1691481-0/1/1 06-Feb-2014 79OHV 3010547781 Guanzhou Prebeauty Electronic Tech. Co China
 
AEK-1691481-0/2/1 06-Feb-2014 79OHV 3010547781 Guanzhou Prebeauty Electronic Tech. Co China
 
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