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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 87-Orthopedic


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
799-1415751-0/1/1 10-Jan-2014 87MAX 3008959623 A Spine Asia Co., Ltd. Taiwan
 
799-1415751-0/2/6 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
799-1415751-0/2/5 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
799-1415751-0/2/15 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
799-1415751-0/2/19 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
799-1415751-0/2/21 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
799-1415751-0/2/23 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
799-1415751-0/2/25 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
799-1415751-0/2/8 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
799-1415751-0/2/3 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
799-1415751-0/2/10 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
799-1415751-0/2/4 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
799-1415751-0/2/7 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
799-1415751-0/2/24 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
799-1415751-0/2/18 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
799-1415751-0/2/16 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
799-1415751-0/2/11 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
799-1415751-0/2/9 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
799-1415751-0/2/1 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
799-1415751-0/2/26 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
799-1415751-0/2/17 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
799-1415751-0/2/14 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
799-1415751-0/2/12 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
799-1415751-0/2/2 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
799-1415751-0/2/27 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
799-1415751-0/2/20 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
799-1415751-0/2/13 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
799-1415751-0/2/22 10-Jan-2014 87MAX 3004745936 R. Gsell Engenering Plastics Switzerland
 
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