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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
799-0552870-3/1/1 27-Sep-2013 87HRX 1017294 Linvatec Corp. dba ConMed Linvatec United States
 
799-0552870-3/2/1 27-Sep-2013 87HRX 3002808088 Scholly Fiberoptic Gmbh Germany
 
799-0502807-6/1/1 30-Sep-2013 87HRX 3002808088 Scholly Fiberoptic Gmbh Germany
 
406-0493215-8/12/10 13-Sep-2013 87HRY 3010307616 Fenin Spain
 
406-0493215-8/13/2 13-Sep-2013 87HSP 3003999451 Fresco Podologia S.L. Spain
 
406-0493215-8/12/15 13-Sep-2013 87HWC 3010307616 Fenin Spain
 
406-0493215-8/12/8 13-Sep-2013 87JDI 3010307616 Fenin Spain
 
406-0493215-8/12/11 13-Sep-2013 87KTT 3010307616 Fenin Spain
 
406-0493215-8/13/1 13-Sep-2013 87KWH 3003999451 Fresco Podologia S.L. Spain
 
406-0493215-8/12/1 13-Sep-2013 87KWL 3010307616 Fenin Spain
 
406-0493215-8/12/12 13-Sep-2013 87KWQ 3010307616 Fenin Spain
 
406-0493215-8/12/2 13-Sep-2013 87KWY 3010307616 Fenin Spain
 
406-0493215-8/12/5 13-Sep-2013 87KWY 3010307616 Fenin Spain
 
406-0493215-8/12/6 13-Sep-2013 87LWJ 3010307616 Fenin Spain
 
UPS-2068233-4/1/1 30-Sep-2013 87LXH 3006386489 S Murray & Co United Kingdom
 
406-0493215-8/12/3 13-Sep-2013 87LZN 3010307616 Fenin Spain
 
406-0493215-8/12/7 13-Sep-2013 87LZO 3010307616 Fenin Spain
 
406-0493215-8/12/4 13-Sep-2013 87LZY 3010307616 Fenin Spain
 
406-0493215-8/12/9 13-Sep-2013 87MBH 3010307616 Fenin Spain
 
406-0493215-8/12/13 13-Sep-2013 87MCV 3010307616 Fenin Spain
 
406-0493215-8/12/16 13-Sep-2013 87MOO 3010307616 Fenin Spain
 
406-0493215-8/12/14 13-Sep-2013 87NDH 3010307616 Fenin Spain
 
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