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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
AEK-9626671-9/1/1 14-Jan-2011 90ITX 3003626808 Krautkramer Inc United States
 
UPS-0701129-5/1/2 11-Jan-2011 90IWZ 3006110525 Kodak Eastman Company United States
 
112-0061904-2/1/1 03-Jan-2011 90IXJ 3008539375 Hologic Inc Canada
 
MH9-0088219-1/1/1 13-Jan-2011 90IZG 3004453295 Dongmun Co., Ltd Korea, Republic Of (South)
 
112-6769876-2/2/2 05-Jan-2011 90IZI 1000249103 Philips Medical Systems Ned Bv Netherlands
 
112-6769876-2/1/1 05-Jan-2011 90JAK 3006422866 PHILIPS MEDICAL SYSTEMS United States
 
112-0131901-4/1/1 06-Jan-2011 90JAK 3006551157 DRGEM CORPORATION Korea, Republic Of (South)
 
112-6769876-2/2/1 05-Jan-2011 90KPR 1000249103 Philips Medical Systems Ned Bv Netherlands
 
HH7-0296939-0/1/1 26-Jan-2011 90LQT 3004753388 Chison Medical Imaging Co., Ltd. China
 
EQW-0002789-8/1/1 03-Jan-2011 90MUA 3008679010 Carlos Rafael Chang Guerra Guatemala
 
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