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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
KB3-0100950-6/1/1 09-May-2002 74DPS 3002096142 H & C Medical Devices Italy
 
MC2-0028299-4/1/1 16-May-2002 74DPS 3002808182 Schiller, Ag Switzerland
 
MC2-0028299-4/1/4 16-May-2002 74DPS 3002808182 Schiller, Ag Switzerland
 
MC2-0077448-7/1/1 03-May-2002 74DRT 3003576550 Shenzhen Mindray Biomedical China
 
MC2-0075284-8/1/1 08-May-2002 74DRT 3003040720 Caymans Mindray Medical Elect China
 
DM9-2010293-4/1/1 02-May-2002 74DSF 3003478608 Dabi Atlante Sa Inds. Brazil
 
416-0072651-1/1/1/A 11-May-2002 74DXN 3002118752 Sugih Instrumendo Abadi, PT. Indonesia
 
H11-0209055-2/1/1 15-May-2002 74DXN 3003620747 Shanghai Universal Imp&Exp Co.,Ltd China
 
H41-3037610-0/1/1 10-May-2002 74DYE 2025587 Medtronic Cardiovascular Surgery-the Heart Valve Division United States
 
F11-2364919-8/1/1 09-May-2002 74KRG 3003227604 Guidant Singapore Pte Ltd Singapore
 
DP4-4033880-5/1/1 21-May-2002 74LDF 1421233 A & E Industries Inc. United States
 
DM9-2010295-9/1/1 02-May-2002 74MHX 3003118430 Erka Kallmeyer Medizintechnik Gmbh And Co Germany
 
DM9-2010295-9/2/1 02-May-2002 74MHX 3003118430 Erka Kallmeyer Medizintechnik Gmbh And Co Germany
 
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