• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Import Refusal Report

  • Print
  • Share
  • E-mail
-

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
FR1-0015356-3/1/1 26-Dec-2013 80BRZ 3005669815 Amsino Medical (Kunshan) Co., Ltd. China
 
HG8-0143832-3/7/1 19-Dec-2013 80FLL 3010514362 Bomag Marini Latin America Brazil
 
279-3312044-9/1/1 20-Dec-2013 80FLL 3010486059 Henry Schein Services Gmbh Germany
 
279-3312044-9/2/1 20-Dec-2013 80FLL 3010486059 Henry Schein Services Gmbh Germany
 
AEK-1755757-6/2/1 24-Dec-2013 80FMI 3006412304 KRS Global Biotechnology, Inc United States
 
FR1-0015313-4/2/1 02-Dec-2013 80FOZ 3004070915 Hanako Medical Japan
 
FR1-0015321-7/1/1 26-Dec-2013 80FRN 3007363456 Tianjin Hanaco Xingda Medical Co., Ltd. China
 
113-6423071-1/20/1 12-Dec-2013 80KGX 3010063269 Rfx+Care Manufacturing Co. Ltd China
 
113-6423071-1/21/1 12-Dec-2013 80KGX 3010063269 Rfx+Care Manufacturing Co. Ltd China
 
113-6423071-1/23/1 12-Dec-2013 80KGX 3010063269 Rfx+Care Manufacturing Co. Ltd China
 
UPS-3244444-2/1/1 24-Dec-2013 80KGX 3008208852 Gm Sourcing Ltd. China
 
UPS-1710973-2/1/1 28-Dec-2013 80KGX 3005761322 ASO Americas, SRL de C.V. Mexico
 
BUP-1571089-3/2/1 20-Dec-2013 80KXG 3002444944 Copan Italia Italy
 
BUP-1571089-3/2/2 20-Dec-2013 80KXG 3002444944 Copan Italia Italy
 
112-3763672-1/1/1 27-Dec-2013 80KYZ 3006896175 Merz Pharma GmbH & Co., KGaA Germany
 
336-9666571-4/1/1 30-Dec-2013 80KZD 3002088009 Smiths Medical International Ltd. United Kingdom
 
799-1596378-3/1/1 13-Dec-2013 80KZE 3003965684 Sarl Mdj France
 
XXX-0182343-5/2/1 11-Dec-2013 80LDQ 3010490914 Rita Shari China
 
BUP-1571089-3/3/1 20-Dec-2013 80LYY 3006483892 Ansell Healthcare Europe Nv Belgium
 
BUP-1571089-3/3/2 20-Dec-2013 80LYY 3006483892 Ansell Healthcare Europe Nv Belgium
 
MC2-6417675-1/1/1 02-Dec-2013 80LYZ 3010034129 Geenli Plastic Co. Ltd China
 
MC2-6417675-1/2/1 02-Dec-2013 80LYZ 3010047788 Hebei Leader Plastic Co., Ltd. China
 
MC2-6405477-6/1/1 17-Dec-2013 80LYZ 3007143709 SHIJIAZHUANG PROSPEROUS PLASTIC CO., LTD China
 
BJV-0728799-9/1/1 18-Dec-2013 80LYZ 3008918827 Advanced Medical Devices Factory China
 
BJV-0728799-9/1/2 18-Dec-2013 80LYZ 3008918827 Advanced Medical Devices Factory China
 
BJV-0728799-9/1/4 18-Dec-2013 80LYZ 3008918827 Advanced Medical Devices Factory China
 
BJV-0728799-9/1/3 18-Dec-2013 80LYZ 3008918827 Advanced Medical Devices Factory China
 
MC2-6411988-4/1/1 30-Dec-2013 80LYZ 3009758390 Zibo Tengyue Plastic Products Co., Ltd. China
 
655-1779034-5/5/1 30-Dec-2013 80LYZ 3006113156 SHIJIAZHUANG LIANHE SHUNDA PLASTIC PRODUCTS CO., L China
 
655-1779034-5/6/1 30-Dec-2013 80LYZ 3006113156 SHIJIAZHUANG LIANHE SHUNDA PLASTIC PRODUCTS CO., L China
 
655-1779034-5/7/1 30-Dec-2013 80LYZ 3006113156 SHIJIAZHUANG LIANHE SHUNDA PLASTIC PRODUCTS CO., L China
 
655-1779034-5/8/1 30-Dec-2013 80LYZ 3006113156 SHIJIAZHUANG LIANHE SHUNDA PLASTIC PRODUCTS CO., L China
 
BUP-3519783-2/1/1 20-Dec-2013 80OKH 3010471355 Viroclinics Netherlands
 
-
-