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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 90-Radiological


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
900-0070920-5/12/1 23-Nov-2012 90IWZ 3002809633 Agfa-Gevart NV Belgium
 
900-0070920-5/18/1 23-Nov-2012 90IWZ 3002809633 Agfa-Gevart NV Belgium
 
900-0070920-5/7/1 23-Nov-2012 90IWZ 3002809633 Agfa-Gevart NV Belgium
 
900-0070920-5/4/1 23-Nov-2012 90IWZ 3002809633 Agfa-Gevart NV Belgium
 
900-0070899-1/18/1 28-Nov-2012 90IWZ 3002809633 Agfa-Gevart NV Belgium
 
900-0070899-1/12/1 28-Nov-2012 90IWZ 3002809633 Agfa-Gevart NV Belgium
 
900-0070899-1/6/1 28-Nov-2012 90IWZ 3002809633 Agfa-Gevart NV Belgium
 
ATK-4027869-0/1/1 16-Nov-2012 90IYJ 3002466018 Siemens Ag Medical Solutions Germany
 
900-0070920-5/1/1 23-Nov-2012 90IZL 3002809633 Agfa-Gevart NV Belgium
 
900-0070920-5/14/1 23-Nov-2012 90IZL 3002809633 Agfa-Gevart NV Belgium
 
900-0070920-5/8/1 23-Nov-2012 90IZL 3002809633 Agfa-Gevart NV Belgium
 
900-0070899-1/13/1 28-Nov-2012 90IZL 3002809633 Agfa-Gevart NV Belgium
 
900-0070899-1/1/1 28-Nov-2012 90IZL 3002809633 Agfa-Gevart NV Belgium
 
900-0070899-1/7/1 28-Nov-2012 90IZL 3002809633 Agfa-Gevart NV Belgium
 
112-9677427-1/1/1 05-Nov-2012 90JAK 1218950 Philips Medical Systems, Inc. United States
 
112-9677427-1/2/1 05-Nov-2012 90JAK 1218950 Philips Medical Systems, Inc. United States
 
112-9677427-1/5/1 05-Nov-2012 90JAK 1218950 Philips Medical Systems, Inc. United States
 
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