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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
336-6938742-8/1/1 05-May-2009 74DQX 1317056 Navilyst Medical, Inc United States
 
336-6938742-8/1/2 05-May-2009 74DQX 1317056 Navilyst Medical, Inc United States
 
336-6938742-8/1/3 05-May-2009 74DQX 1317056 Navilyst Medical, Inc United States
 
336-6939177-6/1/1 05-May-2009 74DQX 1317056 Navilyst Medical, Inc United States
 
DM9-9010417-4/1/1 13-May-2009 74DXT 3006316319 Medrad Inc United States
 
DM9-9010417-4/2/1 13-May-2009 74DXT 3006316319 Medrad Inc United States
 
112-7156915-7/1/1 24-May-2009 74LIT 3002755526 Creganna Medical Devices Ireland
 
322-0016447-7/1/1 13-May-2009 74MLD 3002806783 GE Healthcare Finland Oy Finland
 
322-0016447-7/2/1 13-May-2009 74MLD 3002806783 GE Healthcare Finland Oy Finland
 
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