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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
112-8668450-1/1/1 19-Oct-2005 74DRT 3005360555 Renal Dynamics United States
 
110-2552234-6/1/1 18-Oct-2005 74DWJ 3002807626 Covidien, formerly MMJ S.A de C.V. Mexico
 
110-2552234-6/1/2 18-Oct-2005 74DWJ 3002807626 Covidien, formerly MMJ S.A de C.V. Mexico
 
510-6538714-7/1/1 27-Oct-2005 74DXH 3002438897 Card Guard Scientific Survival, LTD. Israel
 
234-0107645-2/6/1 06-Oct-2005 74DXQ 3004179947 Vikas Fashion India
 
110-1638898-9/1/1 19-Oct-2005 74DXY 3003541262 St. Jude Medical Ab Sweden
 
112-8525678-0/1/1 24-Oct-2005 74JOW 3004207201 Advanced Orthotic Solutions United Kingdom
 
112-8525678-0/1/3 24-Oct-2005 74JOW 3004207201 Advanced Orthotic Solutions United Kingdom
 
110-0822719-1/1/1 15-Oct-2005 74KRI 3005247876 W L Gore 7 Associates Bv Netherlands
 
234-0107645-2/5/1 06-Oct-2005 74LDE 3004179947 Vikas Fashion India
 
112-8395207-5/1/1 25-Oct-2005 74MAF 3002806368 Angiomed GmbH & Co. Medizintechnik KG Germany
 
BIP-0005630-1/1/1 04-Oct-2005 74MLD 3004735094 Ge Healthcare Finland
 
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