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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
799-1016107-8/1/1 09-Jan-2014 90ITX 3002087856 SonoSite, Inc. United States
 
900-0077743-4/1/1 31-Jan-2014 90IWZ 3002809633 Agfa-Gevaert NV Belgium
 
D51-1129944-7/1/1 08-Jan-2014 90IYN 1218950 Philips Medical Systems, Inc. United States
 
D51-1129944-7/2/1 08-Jan-2014 90IYN 1218950 Philips Medical Systems, Inc. United States
 
D51-1129944-7/3/1 08-Jan-2014 90IYN 1218950 Philips Medical Systems, Inc. United States
 
DO7-0602150-1/1/1 13-Jan-2014 90IYN 3004767743 Uab Telemed Lithuania
 
900-0077986-9/1/1 28-Jan-2014 90IZL 3003772616 Agfa HealthCare GmbH, Werk Peissenberg Germany
 
900-0077986-9/2/1 28-Jan-2014 90IZL 3003772616 Agfa HealthCare GmbH, Werk Peissenberg Germany
 
AEK-1141413-9/1/1 28-Jan-2014 90JAA 1000249103 Philips Medical Systems Ned Bv Netherlands
 
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