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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 80-General Hospital/Personal Use


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
FR1-0014627-8/1/1 07-Jan-2013 80BRZ 3003238685 Shanghai Amsino Medical Devices Co., Ltd. China
 
106-0247095-6/7/1 11-Jan-2013 80FLL 3001639514 Mart Tiller Corp Taiwan
 
144-5247538-0/1/1 03-Jan-2013 80FOZ 3006621386 Guangdong Baihe Medical Technology Co., Ltd China
 
FR1-0014732-6/1/1 07-Jan-2013 80FPK 3005137998 Nipro (Sha) Co., Ltd China
 
AEK-0316802-4/1/1 10-Jan-2013 80FRL 3009797539 Web International India
 
FR1-0014774-8/3/1 07-Jan-2013 80FRN 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0014718-5/3/1 07-Jan-2013 80FRN 3007482089 Miyuki Elex Co.,Ltd Japan
 
EDX-0009956-4/1/1 31-Jan-2013 80KCT 3005622231 Multimedical S.R.L. Italy
 
XXX-0230620-8/1/1 07-Jan-2013 80KGX 3007386209 Bsn Medical Colombia
 
MA7-0283499-9/2/1 22-Jan-2013 80KMI 3003971136 Edan Instruments, Inc. China
 
MA7-0283499-9/1/1 22-Jan-2013 80KMI 3003971136 Edan Instruments, Inc. China
 
112-0585294-6/1/1 23-Jan-2013 80KYS 3009873731 Vrote China
 
BYV-0025293-8/1/1 15-Jan-2013 80KZF 3000315977 Fanem Ltda Brazil
 
BYV-0025203-7/1/1 31-Jan-2013 80KZF 3002998192 China National Agricultural Machinery Import/Export Corp China
 
BYV-0025204-5/1/1 31-Jan-2013 80KZF 3002998192 China National Agricultural Machinery Import/Export Corp China
 
BYV-0025205-2/1/1 31-Jan-2013 80KZF 3002998192 China National Agricultural Machinery Import/Export Corp China
 
BYV-0025206-0/1/1 31-Jan-2013 80KZF 3002998192 China National Agricultural Machinery Import/Export Corp China
 
BYV-0025207-8/1/1 31-Jan-2013 80KZF 3002998192 China National Agricultural Machinery Import/Export Corp China
 
XXX-0231228-9/1/1 14-Jan-2013 80KZH 3003499913 Shandong Zibo Shanchuan Medical Instrument Co. Ltd. China
 
AEK-0642652-8/1/1 14-Jan-2013 80LDQ 3009036529 Weifang Km Electronics Co Ltd China
 
EQ6-0015979-0/1/1 15-Jan-2013 80LDQ 5833 EPPENDORF AG Germany
 
EQ6-0016072-3/1/1 29-Jan-2013 80LDQ 5833 EPPENDORF AG Germany
 
R13-0022393-9/1/2 03-Jan-2013 80LYY 3003767009 Indusrial Clothings Limited Sri Lanka
 
R13-0022393-9/1/3 03-Jan-2013 80LYY 3003767009 Indusrial Clothings Limited Sri Lanka
 
R13-0022393-9/1/4 03-Jan-2013 80LYY 3003767009 Indusrial Clothings Limited Sri Lanka
 
R13-0022393-9/1/5 03-Jan-2013 80LYY 3003767009 Indusrial Clothings Limited Sri Lanka
 
R13-0022393-9/1/7 03-Jan-2013 80LYY 3003767009 Indusrial Clothings Limited Sri Lanka
 
R13-0022393-9/1/1 03-Jan-2013 80LYY 3003767009 Indusrial Clothings Limited Sri Lanka
 
R13-0022393-9/1/8 03-Jan-2013 80LYY 3003767009 Indusrial Clothings Limited Sri Lanka
 
R13-0022393-9/1/6 03-Jan-2013 80LYY 3003767009 Indusrial Clothings Limited Sri Lanka
 
WC1-8549257-4/5/1 04-Jan-2013 80LYY 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8538486-2/4/1 08-Jan-2013 80LYY 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8567730-7/17/1 08-Jan-2013 80LYY 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8553914-3/1/1 09-Jan-2013 80LYY 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8568400-6/35/1 09-Jan-2013 80LYY 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8567458-5/234/1 09-Jan-2013 80LYY 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8568223-2/37/1 11-Jan-2013 80LYY 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8567460-1/146/1 14-Jan-2013 80LYY 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8567551-7/176/1 14-Jan-2013 80LYY 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8540447-0/125/1 23-Jan-2013 80LYY 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8537849-2/238/1 23-Jan-2013 80LYY 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
231-4396870-3/1/2 11-Jan-2013 80LYZ 3008177918 Tangshan Kangyuan Glove Co Ltd China
 
R13-0022393-9/2/3 03-Jan-2013 80LZA 3003767009 Indusrial Clothings Limited Sri Lanka
 
R13-0022393-9/2/1 03-Jan-2013 80LZA 3003767009 Indusrial Clothings Limited Sri Lanka
 
R13-0022393-9/2/2 03-Jan-2013 80LZA 3003767009 Indusrial Clothings Limited Sri Lanka
 
WC1-8549257-4/1/1 04-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8549257-4/2/1 04-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8549257-4/3/1 04-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8549257-4/4/1 04-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8549257-4/6/1 04-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8539956-3/25/1 07-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8539956-3/64/1 07-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8538400-3/29/1 07-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8538400-3/30/1 07-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8538486-2/35/1 07-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8538486-2/36/1 07-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8538821-0/36/1 08-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8538821-0/78/1 08-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8538821-0/79/1 08-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8547143-8/25/1 08-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8539810-2/57/1 08-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8538481-3/90/1 08-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8540446-2/5/1 09-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8541257-2/193/1 09-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8541257-2/317/1 09-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8542261-3/6/1 09-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8546694-1/359/1 09-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8546825-1/5/1 09-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8547108-1/44/1 09-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8553914-3/2/1 09-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8539638-7/36/1 09-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8539638-7/116/1 09-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
413-9020896-0/153/1 17-Jan-2013 80LZA 1000153953 Laglove Sdn Bhd (M) aka LA Glove Malaysia
 
WC1-8546803-8/137/1 23-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8546803-8/478/1 23-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8539151-1/226/1 23-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8546686-7/422/1 23-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8545936-7/124/1 23-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8546688-3/244/1 23-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8546263-5/533/1 23-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8539158-6/426/1 23-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8545873-2/445/1 23-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8546306-2/243/1 23-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8546306-2/232/1 23-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8546333-6/277/1 23-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8546453-2/46/1 23-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8546815-2/35/1 23-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8538493-8/159/1 23-Jan-2013 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
EJK-0030361-1/1/1 15-Jan-2013 80LZC 3003069816 SGMP Company Limited Thailand
 
112-0405917-0/18/1 04-Jan-2013 80MED 3006846433 Inkutec Gmbh Germany
 
XXX-0230620-8/1/15 07-Jan-2013 80MLR 3005304585 3m Columbia S.A. Colombia
 
XXX-0230620-8/1/16 07-Jan-2013 80MLR 3005304585 3m Columbia S.A. Colombia
 
112-0406419-6/1/1 04-Jan-2013 80NSC 3002926090 RI. MOS S.R.L. Italy
 
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