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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 74-Cardiovascular


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-8865441-6/1/1 07-Sep-2012 74DPS 3003190524 WIPRO GE HEALTHCARE PRIVATE LTD. India
 
BJY-0710302-9/5/1 07-Sep-2012 74DPS 3005694554 BTL Industries Ltd. United Kingdom
 
112-9397214-2/1/1 20-Sep-2012 74DQK 3009740147 Epi Mobile Health Solution (S) PTE LTD Singapore
 
112-9109734-8/1/1 07-Sep-2012 74DQY 3006646601 Vascular Solutions United States
 
112-8859625-2/2/1 14-Sep-2012 74DTL 3009682046 Protesis Y Material Medico Espec Honduras
 
112-8996449-1/1/1 05-Sep-2012 74DTY 3009695940 Unique Co. Japan
 
112-8662979-0/1/1 14-Sep-2012 74DXN 3009675596 Shenzhen Tianxia Huitong China
 
101-3012358-1/1/1 04-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3002965-5/1/1 04-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3012338-3/1/1 04-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3012459-7/1/1 04-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3012486-0/1/1 04-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3012523-0/1/1 04-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3105935-4/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3105946-1/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3105956-0/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3105967-7/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3105975-0/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3105989-1/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3106029-5/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3106465-1/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3106490-9/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3106500-5/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3106528-6/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3106836-3/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3106842-1/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3107754-7/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3107772-9/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3107782-8/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3110608-0/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3110631-2/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3110644-5/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3117153-0/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3117384-1/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3117401-3/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3117422-9/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3117448-4/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3117462-5/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3117481-5/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3117504-4/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3118143-0/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3118222-2/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3118246-1/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3118269-3/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3118293-3/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3119813-7/1/1 13-Sep-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
D52-9001978-0/4/1 04-Sep-2012 74DXQ 3007191870 Wah Sum Hong (Hong Kong) Limited Hong Kong SAR
 
600-7287493-0/2/1 05-Sep-2012 74DXT 3003005935 Nemoto Kyorindo Company Ltd. Japan
 
EDX-0009966-3/1/1 07-Sep-2012 74DYG 3009462102 Quindao Carefully International Trade China
 
DNA-1331960-7/1/1 20-Sep-2012 74JOP 3009286593 Ultrasonic Medical Co Canada
 
112-9203183-3/1/1 18-Sep-2012 74LWR 3003956144 Admedes Schuessler GmbH Germany
 
112-9203183-3/2/1 18-Sep-2012 74LWR 3003956144 Admedes Schuessler GmbH Germany
 
112-9203183-3/3/1 18-Sep-2012 74LWR 3003956144 Admedes Schuessler GmbH Germany
 
112-8624214-9/1/1 07-Sep-2012 74MAF 3005969022 Hemoteq Gmbh Germany
 
112-8859625-2/2/2 14-Sep-2012 74MAF 3009682046 Protesis Y Material Medico Espec Honduras
 
112-8859625-2/3/1 14-Sep-2012 74MFB 3009682046 Protesis Y Material Medico Espec Honduras
 
112-9450014-0/1/1 17-Sep-2012 74MHX 3004070007 Egg Company Japan
 
112-8859625-2/1/1 14-Sep-2012 74NIQ 3009682046 Protesis Y Material Medico Espec Honduras
 
112-8859625-2/2/3 14-Sep-2012 74OFB 3009682046 Protesis Y Material Medico Espec Honduras
 
112-8859625-2/2/4 14-Sep-2012 74OFC 3009682046 Protesis Y Material Medico Espec Honduras
 
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