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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
112-0399216-4/1/1 26-Jan-2011 87HTY 3007040923 Bio-Med Biomaterials France
 
112-5078136-0/1/4 07-Jan-2011 87HWC 3008012893 Link Manufacturing S.A Switzerland
 
112-9929067-0/1/1 07-Jan-2011 87HWE 3005349727 Smith & Nephew United States
 
112-5078136-0/1/1 07-Jan-2011 87HWT 3008012894 Link Manufacturing S.A Switzerland
 
UPS-0113373-1/1/2 03-Jan-2011 87HXK 3003186984 The Mughal Surgical (Pvt) Ltd. Pakistan
 
112-0157844-5/1/2 05-Jan-2011 87HXK 3004671812 McKesson Medical-Surgical MN Supply Inc. United States
 
BJV-0234425-8/89/10 12-Jan-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0234523-0/68/1 12-Jan-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
112-7800710-2/1/2 04-Jan-2011 87KXE 1000228440 Otto Bock Health Care Canada
 
112-5078136-0/1/2 07-Jan-2011 87LXH 3008012893 Link Manufacturing S.A Switzerland
 
112-5078136-0/1/3 07-Jan-2011 87LXH 3008012893 Link Manufacturing S.A Switzerland
 
112-5078136-0/1/5 07-Jan-2011 87LXH 3008012893 Link Manufacturing S.A Switzerland
 
112-5078136-0/1/6 07-Jan-2011 87LXH 3008012893 Link Manufacturing S.A Switzerland
 
112-5078136-0/1/7 07-Jan-2011 87LXH 3008012893 Link Manufacturing S.A Switzerland
 
112-5078136-0/1/8 07-Jan-2011 87LXH 3008012893 Link Manufacturing S.A Switzerland
 
112-5078136-0/1/9 07-Jan-2011 87LXH 3008012893 Link Manufacturing S.A Switzerland
 
112-5078136-0/2/1 07-Jan-2011 87MOO 3008012893 Link Manufacturing S.A Switzerland
 
112-7800710-2/1/1 04-Jan-2011 87MQO 1000228440 Otto Bock Health Care Canada
 
112-0568430-6/1/1 31-Jan-2011 87MQV 3003897776 Biomimetic Therapeutics Inc United States
 
112-5240227-0/1/1 06-Jan-2011 87NKH 3004739527 Exa France France
 
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