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FDA 510(k) Applications Submitted by BioMedical Enterprises, Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K150125
01/20/2015
Elite Nitinol Fixation System
BioMedical Enterprises, Inc.
K142292
08/18/2014
Speed, Speed Shift, Speed Titan, Speed Arc
BioMedical Enterprises, Inc.
K143023
10/21/2014
Nitinol Compression Plating System
BioMedical Enterprises, Inc.
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