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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
G33-0166863-5/1/1 24-Aug-2012 74DQF 3002677363 Helm Ag Germany
 
BJY-0710268-2/1/4 29-Aug-2012 74DQY 3009655546 Redax S.R.L. Italy
 
AWM-0019313-8/1/1 06-Aug-2012 74DRF 3002807561 Medtronic B.V. Netherlands
 
101-9809495-4/3/1 09-Aug-2012 74DRS 3009471097 Edwards Lifesciences Ag Dominican Republic
 
UPS-7307833-5/1/2 06-Aug-2012 74DTE 3002806386 APC Medical, Ltd. United Kingdom
 
406-0478219-9/1/1 06-Aug-2012 74DXN 3009598755 Panyu Wan Rong Fashion China
 
112-8665383-2/1/1 09-Aug-2012 74DXN 3006355451 Medlab Gmbh Germany
 
406-0476161-5/1/1 21-Aug-2012 74DXN 3006704335 Panasonic Electric Works Wanbao China
 
406-0476789-3/1/1 21-Aug-2012 74DXN 3009553984 Panasonic Manufacturing China
 
AEK-0359552-3/1/1 30-Aug-2012 74DXN 3009707592 Hosman International Co Ltd Taiwan
 
101-9809495-4/2/1 09-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9837180-8/1/1 09-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9910076-8/1/1 16-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9910100-6/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9910104-8/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9912713-4/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9913053-4/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9913270-4/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9913350-4/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9927034-8/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9928185-7/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9931538-2/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9934872-2/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9951083-4/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9951105-5/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9951125-3/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9951149-3/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9951163-4/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9951187-3/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9953432-1/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9953443-8/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9953469-3/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9953549-2/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9953587-2/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9955303-2/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9955331-3/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9955491-5/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9955522-7/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9960085-8/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9960094-0/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9960101-3/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9960107-0/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9960121-1/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9960128-6/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9963604-3/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9963638-1/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3001162-0/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3001248-7/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9837187-3/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9837477-8/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9837622-9/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9837698-9/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9837837-3/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9837866-2/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9837904-1/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9840203-3/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9840247-0/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9840760-2/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9842259-3/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9842307-0/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9842774-1/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9842832-7/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9842912-7/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9846624-4/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9849182-0/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9849186-1/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9849191-1/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9849193-7/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9849197-8/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9854798-5/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9856691-0/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9856764-5/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9859088-6/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9859170-2/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9859259-3/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9859569-5/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9860273-1/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9863045-0/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9864319-8/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9877175-9/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9877196-5/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9877256-7/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9877305-2/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9888336-4/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9897456-9/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9897507-9/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9897655-6/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9897753-9/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9898102-8/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9911579-0/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9922195-2/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9923747-9/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9938056-8/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9958582-8/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9958597-6/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9958635-4/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9960075-9/1/1 21-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3002488-8/1/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3002902-8/1/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3003189-1/1/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3005037-0/1/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3005037-0/2/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3005037-0/3/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3005037-0/4/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3005038-8/7/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3005038-8/9/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3005038-8/8/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3005038-8/1/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3005038-8/2/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3005038-8/3/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3005038-8/4/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3005038-8/5/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-3005038-8/6/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9913218-3/1/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9934893-8/1/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9937626-9/1/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9937940-4/1/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9937967-7/1/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9938011-3/1/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9938218-4/1/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9942696-5/1/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9943637-8/1/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9943641-0/1/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9943643-6/1/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9943645-1/1/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9943647-7/1/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9943648-5/1/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9947129-2/1/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9947178-9/1/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9947191-2/1/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9947693-7/1/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9947717-4/1/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9947746-3/1/1 28-Aug-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9942633-8/1/1 28-Aug-2012 74DXP 3009471097 Edwards Lifesciences Ag Dominican Republic
 
AWM-0019280-9/2/1 06-Aug-2012 74DXY 3002807561 Medtronic B.V. Netherlands
 
AWM-0019176-9/1/1 21-Aug-2012 74DXY 3002807561 Medtronic B.V. Netherlands
 
UPS-7307833-5/1/1 06-Aug-2012 74JOQ 3002806386 APC Medical, Ltd. United Kingdom
 
101-9877196-5/3/1 21-Aug-2012 74KRB 3009471097 Edwards Lifesciences Ag Dominican Republic
 
112-7949362-6/1/1 07-Aug-2012 74LPB 3009275100 Contract Medical Intl Gmbh Germany
 
9N5-0001117-6/1/1 13-Aug-2012 74LWR 3003956144 Admedes Schuessler GmbH Germany
 
BJY-0710310-2/3/1 03-Aug-2012 74MKJ 3008463212 Instramed Industria Medico Hospitalar Ltda Brazil
 
BJY-0710310-2/1/1 03-Aug-2012 74MKJ 3008463212 Instramed Industria Medico Hospitalar Ltda Brazil
 
BJY-0710318-5/1/1 03-Aug-2012 74MKJ 3008554756 Osatu S. Corp Spain
 
BJY-0710351-6/1/1 06-Aug-2012 74MKJ 3008463212 Instramed Industria Medico Hospitalar Ltda Brazil
 
AEK-0358349-5/1/1/B 16-Aug-2012 74MNW 3009685444 Gz Marry Beauty Co Ltd China
 
AWM-0019280-9/1/1 06-Aug-2012 74NVN 3002807561 Medtronic B.V. Netherlands
 
AWM-0019176-9/2/1 21-Aug-2012 74NVN 3002807561 Medtronic B.V. Netherlands
 
BJY-0710268-2/1/2 29-Aug-2012 74OFC 3009655546 Redax S.R.L. Italy
 
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