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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
112-4901111-0/1/2 09-Dec-2011 87HTW 3005259373 G B Medical Ltd United Kingdom
 
112-4901111-0/1/4 09-Dec-2011 87HWA 3005259373 G B Medical Ltd United Kingdom
 
112-4901111-0/2/1 09-Dec-2011 87HWC 3005259373 G B Medical Ltd United Kingdom
 
112-8236084-4/1/1 13-Dec-2011 87HWC 3005059805 Leghe Leggere Lavorate Srl Italy
 
112-4901111-0/1/6 09-Dec-2011 87HWX 3005259373 G B Medical Ltd United Kingdom
 
112-2967990-2/1/14 07-Dec-2011 87HXX 1000517406 Paragon Medical United States
 
112-2967990-2/1/5 07-Dec-2011 87HXX 1000517406 Paragon Medical United States
 
112-2967990-2/1/17 07-Dec-2011 87HXX 1000517406 Paragon Medical United States
 
112-4901111-0/1/5 09-Dec-2011 87HXX 3005259373 G B Medical Ltd United Kingdom
 
112-4375475-6/1/1 28-Dec-2011 87JDG 3008035425 Maxx Orthopedics Inc United States
 
112-4626201-3/1/1 05-Dec-2011 87JDO 3005069937 Cousin Bioserv France
 
112-0154003-1/1/1 28-Dec-2011 87JWH 3003124946 Advanced Surgical Design & Manufacture, Ltd. Australia
 
112-1736763-5/1/1 28-Dec-2011 87LWJ 3005462097 Small Bone Innovations Internationl France
 
112-2967990-2/1/1 07-Dec-2011 87LXH 1000517406 Paragon Medical United States
 
112-2967990-2/1/18 07-Dec-2011 87LXH 1000517406 Paragon Medical United States
 
112-2967990-2/1/8 07-Dec-2011 87LXH 1000517406 Paragon Medical United States
 
112-2967990-2/1/3 07-Dec-2011 87LXH 1000517406 Paragon Medical United States
 
112-2967990-2/1/6 07-Dec-2011 87LXH 1000517406 Paragon Medical United States
 
112-2967990-2/1/12 07-Dec-2011 87LXH 1000517406 Paragon Medical United States
 
112-2967990-2/1/15 07-Dec-2011 87LXH 1000517406 Paragon Medical United States
 
112-2967990-2/1/19 07-Dec-2011 87LXH 3000717687 Advantis Medical United States
 
112-2967990-2/1/13 07-Dec-2011 87LXH 1000517406 Paragon Medical United States
 
112-2967990-2/1/10 07-Dec-2011 87LXH 1221934 DePuy Mitek, Inc., a Johnson & Johnson Co. United States
 
112-4762517-4/1/1 16-Dec-2011 87LXI 1045834 The Anspach Effort, Inc. United States
 
112-2967990-2/1/9 07-Dec-2011 87NBH 1221934 DePuy Mitek, Inc., a Johnson & Johnson Co. United States
 
112-2967990-2/1/4 07-Dec-2011 87NBH 1000517406 Paragon Medical United States
 
112-2967990-2/1/11 07-Dec-2011 87NBH 1221934 DePuy Mitek, Inc., a Johnson & Johnson Co. United States
 
112-2967990-2/2/1 07-Dec-2011 87NBH 1000272060 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. Israel
 
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