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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
595-5056883-2/3/1 22-Jul-2013 79FMK 3004562367 KooJoo Trading Company Korea, Republic Of (South)
 
H41-1222900-4/1/1 17-Jul-2013 79FTL 3009758946 Ams Ireland Ltd Ireland
 
112-2874706-5/1/1 05-Jul-2013 79FTM 3005580113 Cook Medical Incorporated United States
 
AEK-0805033-4/1/1 01-Jul-2013 79FTY 3005657093 Sobytex Inst Pakistan
 
186-8623594-8/1/1 17-Jul-2013 79GAA 3008451719 Terumo Corporation Japan
 
112-3500825-3/1/2 26-Jul-2013 79GAK 3004944585 Sutures India Pvt. Ltd. India
 
112-3500825-3/1/1 26-Jul-2013 79GAO 3004944585 Sutures India Pvt. Ltd. India
 
BJY-0711433-1/1/5 24-Jul-2013 79GCD 3004181963 Mediplus Ltd United Kingdom
 
UPS-0699066-9/1/1 01-Jul-2013 79GCJ 3003914558 Royal Jubilee Hosp Canada
 
UPS-0698990-1/1/1 01-Jul-2013 79GCJ 1000132435 Stryker Sustainability Solutions, Inc. United States
 
551-2358905-9/1/1 10-Jul-2013 79GEA 3007071883 Camelot Medical Llc United States
 
112-3363780-6/2/1 25-Jul-2013 79GED 3010259607 Guangdong Gaoyao Linli Town Qifu Needles o., Ltd. China
 
551-2358905-9/1/2 10-Jul-2013 79GEE 3007071883 Camelot Medical Llc United States
 
UPS-1333133-7/1/1 23-Jul-2013 79GEM 2416101 Pfizer Inc. United States
 
AEK-9240052-8/1/1 05-Jul-2013 79GEX 3009786814 Wuhan Gigaa Optronics China
 
112-3194123-4/1/1 16-Jul-2013 79GEX 3004505220 Shanghai Wonderful Opto-Electrics Tech. Co., Ltd. China
 
AEK-9282960-1/1/1 16-Jul-2013 79GFE 3010252591 Guangzhou Chenlu Biotechnology Co China
 
AEK-0805033-4/1/3 01-Jul-2013 79HTD 3005657093 Sobytex Inst Pakistan
 
336-9444293-4/1/1 31-Jul-2013 79HTD 3009222256 Wibi Instruments Pakistan
 
UPS-1496782-4/1/1 26-Jul-2013 79HXD 3009695996 4dimens Aps Denmark
 
UPS-1621755-8/1/1 29-Jul-2013 79HXD 3009258998 Sorribes Online Denmark
 
FD6-3110755-0/1/1 29-Jul-2013 79KGX 3009338263 Ningbo First Import & Export Com.,Ltd China
 
551-2358905-9/1/3 10-Jul-2013 79MUU 3007071883 Camelot Medical Llc United States
 
551-2358905-9/1/4 10-Jul-2013 79MUU 3007071883 Camelot Medical Llc United States
 
551-2358905-9/1/5 10-Jul-2013 79MUU 3007071883 Camelot Medical Llc United States
 
916-2471643-6/12/1 22-Jul-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
916-2471643-6/11/1 22-Jul-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
916-2471643-6/14/1 22-Jul-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
916-2471643-6/33/1 22-Jul-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
916-2471643-6/36/1 22-Jul-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
916-2471643-6/34/1 22-Jul-2013 79NAB 3004950768 Allmed Medical Products Co., Ltd. (Zhijiang Factory) China
 
UPS-1655476-0/1/1/A 25-Jul-2013 79NEC 3004139668 Asepta France
 
UPS-1276094-0/1/1 18-Jul-2013 79OAP 3010247565 Chongqing Derma Optic And Electronic Technique Co China
 
ANQ-2010261-2/2/1 31-Jul-2013 79OAP 3009079050 Ilooda Co Ltd Korea, Republic Of (South)
 
K80-9000563-9/20/1 09-Jul-2013 79OHO 3004528781 Go International Ltd United Kingdom
 
AEK-9175807-4/1/1 09-Jul-2013 79OHV 3010188444 Ousainuo China
 
AEK-9311642-0/1/1 31-Jul-2013 79OHV 3007910224 Melya Beauty Health Equipment China
 
E10-0213082-4/1/1 09-Jul-2013 79OYW 3009036529 Weifang Km Electronics Co Ltd China
 
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