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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
748-0358490-8/1/1 11-Jul-2011 80CAK 3003327833 Ensatec, S.A. de C.V. Mexico
 
748-0358490-8/1/2 11-Jul-2011 80CAK 3003327833 Ensatec, S.A. de C.V. Mexico
 
748-0358490-8/1/3 11-Jul-2011 80CAK 3003327833 Ensatec, S.A. de C.V. Mexico
 
748-0358490-8/1/4 11-Jul-2011 80CAK 3003327833 Ensatec, S.A. de C.V. Mexico
 
112-1631375-4/1/1 26-Jul-2011 80DWL 3008770776 Ela Moravia Czech Republic
 
MH9-0094305-0/1/1 05-Jul-2011 80FLE 3007138511 Shandong Xinhua Medical Instrument Co Ltd China
 
112-8969310-6/1/1/D 25-Jul-2011 80FLE 3004723753 Wilmot Castle United States
 
FR1-0013892-9/1/1 18-Jul-2011 80FMF 3005405146 Shanghai Kindly Enterprise Development Group Co., Ltd. China
 
FR1-0013810-1/1/1 19-Jul-2011 80FMF 3005405146 Shanghai Kindly Enterprise Development Group Co., Ltd. China
 
FR1-0013881-2/1/1 28-Jul-2011 80FMF 3008301436 Nipro Pharma Corp Ohdate Factory Japan
 
NS1-0007365-0/1/2 28-Jul-2011 80FMZ 3006416896 Shangahi Medial Isntrumetns China
 
NS1-0007365-0/1/1 28-Jul-2011 80FMZ 3006416896 Shangahi Medial Isntrumetns China
 
004-5908819-1/4/1 05-Jul-2011 80FOZ 3006425876 Arrow International CR, a.s. Czech Republic
 
FR1-0013906-7/1/1 28-Jul-2011 80FOZ 3004070915 Hanako Medical Japan
 
853-0525496-4/1/1 05-Jul-2011 80FPA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525581-3/7/1 05-Jul-2011 80FPA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0523888-4/1/1 07-Jul-2011 80FPA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0523897-5/1/1 07-Jul-2011 80FPA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
FR1-0013845-7/1/1 19-Jul-2011 80FPK 3005137998 Nipro (Sha) Co., Ltd China
 
FR1-0013910-9/1/1 19-Jul-2011 80FPK 3005137998 Nipro (Sha) Co., Ltd China
 
112-8969310-6/1/1/M 25-Jul-2011 80FRG 3001478867 Ransom & Randolph Co United States
 
AEK-8761760-7/1/1 01-Jul-2011 80FRN 3002088009 Smiths Medical International Ltd. United Kingdom
 
MH9-0094071-8/1/1 18-Jul-2011 80KMI 3008981634 Equipmed Americas Sac Peru
 
MH9-0094683-0/1/1 19-Jul-2011 80KMI 3004595408 Beijing Choice Electronic Technology Co. Ltd China
 
AEK-8245606-8/1/1 25-Jul-2011 80KZF 3006768798 Ground Tech Equipment Co., Ltd Taiwan
 
EQ6-0013509-7/1/1 13-Jul-2011 80LDQ 5833 EPPENDORF AG Germany
 
EQ6-0013510-5/1/1 13-Jul-2011 80LDQ 5833 EPPENDORF AG Germany
 
UPS-2755689-9/1/1 26-Jul-2011 80LDQ 3008986330 Halosense Canada
 
D52-0944841-9/1/10 22-Jul-2011 80LYY 3430 N. S. Uni-Gloves Sdn. Bhd. Malaysia
 
D52-0944841-9/1/11 22-Jul-2011 80LYY 3430 N. S. Uni-Gloves Sdn. Bhd. Malaysia
 
D52-0944841-9/1/12 22-Jul-2011 80LYY 3430 N. S. Uni-Gloves Sdn. Bhd. Malaysia
 
D52-0944841-9/1/13 22-Jul-2011 80LYY 3430 N. S. Uni-Gloves Sdn. Bhd. Malaysia
 
BEA-9214076-9/2/1 08-Jul-2011 80LYZ 3006534695 Jiangsu Cureguard Glove Co., Ltd. China
 
BEA-9214076-9/1/1 08-Jul-2011 80LYZ 3006534695 Jiangsu Cureguard Glove Co., Ltd. China
 
BEA-9214076-9/3/1 08-Jul-2011 80LYZ 3006534695 Jiangsu Cureguard Glove Co., Ltd. China
 
660-2509127-4/4/1 29-Jul-2011 80LYZ 3007923136 ZIBO YUSHENG PLASTIC PRODUCTS COMPANY LIMITED China
 
660-2509127-4/1/1 29-Jul-2011 80LYZ 3007923136 ZIBO YUSHENG PLASTIC PRODUCTS COMPANY LIMITED China
 
660-2509127-4/2/1 29-Jul-2011 80LYZ 3007923136 ZIBO YUSHENG PLASTIC PRODUCTS COMPANY LIMITED China
 
660-2509127-4/3/1 29-Jul-2011 80LYZ 3007923136 ZIBO YUSHENG PLASTIC PRODUCTS COMPANY LIMITED China
 
660-2509327-0/4/1 29-Jul-2011 80LYZ 3007923136 ZIBO YUSHENG PLASTIC PRODUCTS COMPANY LIMITED China
 
660-2509327-0/3/1 29-Jul-2011 80LYZ 3007923136 ZIBO YUSHENG PLASTIC PRODUCTS COMPANY LIMITED China
 
660-2509327-0/2/1 29-Jul-2011 80LYZ 3007923136 ZIBO YUSHENG PLASTIC PRODUCTS COMPANY LIMITED China
 
660-2509327-0/1/1 29-Jul-2011 80LYZ 3007923136 ZIBO YUSHENG PLASTIC PRODUCTS COMPANY LIMITED China
 
112-2665636-6/1/1 12-Jul-2011 80LZA 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
112-8969310-6/1/1/K 25-Jul-2011 80MXI 3003705856 Richmond Dental Co United States
 
112-8969310-6/1/1/E 25-Jul-2011 80NKK 1000002651 Nipro Medical Industries Ltd Japan
 
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