W.L. Gore & Associates, Inc. - FDA 510(k) Cleared Devices
163
Total
148
Cleared
0
Denied
61 devices
Cleared
Jul 31, 2019
GORE BIO-A Tissue Reinforcement
General & Plastic Surgery
29d
Cleared
Aug 17, 2018
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement
General & Plastic Surgery
29d
Cleared
Apr 05, 2018
GORE ENFORM Biomaterial
General & Plastic Surgery
164d
Cleared
May 11, 2017
GORE SYNECOR Preperitoneal Biomaterial
General & Plastic Surgery
143d
Cleared
Feb 10, 2017
GORE BIO-A Tissue Reinforcement
General & Plastic Surgery
86d
Cleared
Dec 11, 2015
GORE SYNECOR Biomaterial
General & Plastic Surgery
88d
Cleared
Mar 30, 2015
GORE SEAMGUARD Reinforcement
General & Plastic Surgery
26d
Cleared
May 07, 2014
GORE BIO-A WOUND MATRIX
General & Plastic Surgery
279d
Cleared
Sep 06, 2013
GORE SEAMGUARD REINFORCEMENT
General & Plastic Surgery
92d
Cleared
Mar 27, 2009
GORE BIO-A FISTULA PLUG
General & Plastic Surgery
142d
Cleared
May 30, 2008
GORE INFINIT MESH
General & Plastic Surgery
45d
Cleared
Apr 02, 2007
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS
General & Plastic Surgery
25d
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