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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
112-6748757-2/1/1 06-Apr-2012 74DPS 3009275215 Cardiocore United States
 
BUP-1538745-2/1/1 17-Apr-2012 74DPS 2183461 Mortara Instrument, Inc United States
 
112-5840123-6/1/2 10-Apr-2012 74DRC 1000132435 Stryker Sustainability Solutions, Inc. United States
 
112-7195904-6/1/1 30-Apr-2012 74DSA 3009500821 Hk Upnmed Tech Co Ld China
 
101-5030349-2/18/1 13-Apr-2012 74DTW 3003100703 SMTC CORPORATION Mexico
 
112-6698591-5/1/1 30-Apr-2012 74DXN 3009265909 Tensiomed Kft Hungary
 
112-6683303-2/2/1 30-Apr-2012 74DXN 3003247551 Rossmax International Ltd. Taiwan
 
AWM-0019112-4/1/1 16-Apr-2012 74DXY 3002807561 Medtronic B.V. Netherlands
 
112-6543688-6/1/1 20-Apr-2012 74DYB 3006274289 Microplast Ab Sweden
 
322-0644538-3/11/1 17-Apr-2012 74LLK 3009203894 Wintersteiger Ag Austria
 
322-0644538-3/12/1 17-Apr-2012 74LLK 3009203894 Wintersteiger Ag Austria
 
322-0644538-3/13/1 17-Apr-2012 74LLK 3009203894 Wintersteiger Ag Austria
 
322-0644538-3/14/1 17-Apr-2012 74LLK 3009203894 Wintersteiger Ag Austria
 
322-0644538-3/15/1 17-Apr-2012 74LLK 3009203894 Wintersteiger Ag Austria
 
AWM-0019112-4/2/1 16-Apr-2012 74NVN 3002807561 Medtronic B.V. Netherlands
 
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