TELA Bio, Inc. is one of 16105 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
TELA Bio, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Liora Monofilament Scaffold, OviTex PRS (Long-Term Resorbable), OviTex PRS
4
Total
4
Cleared
0
Denied
TELA Bio, Inc. has 4 FDA 510(k) cleared medical devices. Based in Malvern, US.
Latest FDA clearance: Sep 2026. Active since 2014. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by TELA Bio, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - TELA Bio, Inc.
4 devices
Cleared
Sep 28, 2026
Liora Monofilament Scaffold
General & Plastic Surgery
228d
Cleared
Dec 19, 2024
OviTex PRS (Long-Term Resorbable)
General & Plastic Surgery
29d
Cleared
May 22, 2024
OviTex PRS
General & Plastic Surgery
29d
Cleared
Dec 11, 2014
OVINE TISSUE MATRIX(OTM)
General & Plastic Surgery
231d