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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
AEK-1700672-3/1/1 21-Jan-2014 74DPS 3006979678 CONTEC MEDICAL SYSTEMS CO., LTD China
 
799-1738380-8/1/1 14-Jan-2014 74DQR 3004028778 Dixons Surgical Instruments Ltd. United Kingdom
 
799-2080052-5/1/1 10-Jan-2014 74DQX 3007021274 Galvarex Sa Switzerland
 
799-1003173-5/1/1 10-Jan-2014 74DQX 3009348085 Newtech Medical Devices India
 
799-2224406-0/1/1 16-Jan-2014 74DQY 3004066202 Invatec S.p.A. Italy
 
799-1435155-0/1/1 16-Jan-2014 74DQY 3004066202 Invatec S.p.A. Italy
 
101-3575950-4/10/1 31-Jan-2014 74DRC 3002806934 Kendall Company L.P. Mexico
 
101-3575950-4/11/1 31-Jan-2014 74DRC 3002806934 Kendall Company L.P. Mexico
 
101-3575950-4/49/1 31-Jan-2014 74DRC 3002806934 Kendall Company L.P. Mexico
 
101-3575950-4/50/1 31-Jan-2014 74DRC 3002806934 Kendall Company L.P. Mexico
 
101-3575950-4/51/1 31-Jan-2014 74DRC 3002806934 Kendall Company L.P. Mexico
 
101-3575950-4/52/1 31-Jan-2014 74DRC 3002806934 Kendall Company L.P. Mexico
 
799-1541806-9/3/1 03-Jan-2014 74DRX 3008289288 Natus Neurology Incorporated United States
 
799-1488409-7/1/1 10-Jan-2014 74DTB 3010451656 Unixo United States
 
799-1586750-5/1/1 03-Jan-2014 74DXN 3001373226 Omron (Dalian) Co., Ltd. (Plant 1) China
 
406-0498321-9/1/1 28-Jan-2014 74DXN 3010547367 Panasonic Manufacturing(Shanghai)Co China
 
JF7-0109094-2/1/1 24-Jan-2014 74MAF 3005718570 Abbott Vascular Ireland
 
JF7-0109093-4/1/1 22-Jan-2014 74MRM 3010216210 St Jude Medical Bc Belgium
 
799-1541806-9/1/1 03-Jan-2014 74OED 3006258337 Somnomedics Gmbh Germany
 
AEK-0149655-9/1/1 16-Jan-2014 74OEU 3009297414 Temmed Medical China
 
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