FDA 510(k) Applications for Medical Device Product Code "OWT"

FDA 510(k) Number Applicant Device Name Decision Date
K203267 Biorez, Inc. The BioBrace Implant 04/30/2021
K143380 C. R. Bard Inc Phasix ST Mesh 06/05/2015
K173143 C. R. Bard Inc Phasix ST Mesh 04/25/2018
K120728 C.R. BARD INC PHASIX PLUG AND PATCH 10/22/2012
K190185 C.R. Bard, Inc. Phasix ST Mesh with Open Positioning System 06/12/2019
K163005 NOVUS SCIENTIFIC AB TIGR Matrix Surgical Mesh 07/27/2017
K191749 Novus Scientific AB TIGR Matrix Surgical Mesh, TIGR Surgical Mesh 03/26/2020
K101287 TEPHA, INC. TEPHAFLEX COMPOSITE MESH 08/30/2010
K033671 W. L. GORE & ASSOCIATES, INC. GORE BIOABSORBABLE MESH 12/31/2003
K191773 W.L. Gore & Associates, Inc. GORE BIO-A Tissue Reinforcement 07/31/2019


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