Tela Bio Inc

FDA Filings

This page includes the latest FDA filings for Tela Bio Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USANASDAQTELADUNS 078721472
FDA Registration(s)
Registration Number3010513348
FEI Number3010513348
NameTELA BIO, INC.
Owner & OperatorTELA Bio
Contact Address1 Great Valley Parkway, Suite 24
Malvern PA 19355 US
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address1 GREAT VALLEY PKWY STE 24
Malvern, PA 19355 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
TELA BIO, INC.
OviTex® 2024-10-23
TELA BIO, INC.
OviTex® 2024-08-27
TELA BIO, INC.
OviTex® 2024-06-17
TELA BIO, INC.
OviTex® PRS P20263-1122G2023-07-20
TELA BIO, INC.
OviTex® PRS P20263-1020G2023-07-20
TELA BIO, INC.
OviTex® PRS P20263-0815G2023-07-20
TELA BIO, INC.
OviTex® PRS P20363-2025G2023-07-20
TELA BIO, INC.
OviTex® PRS P20163-2020G2023-07-20
TELA BIO, INC.
OviTex® PRS P20163-1620G2023-07-20
TELA BIO, INC.
OviTex® 2022-06-29
TELA BIO, INC.
OviTex® 2022-06-29
TELA BIO, INC.
OviTex® 2022-05-25
TELA BIO, INC.
OviTex® 2022-05-04
TELA BIO, INC.
OviTex® 2022-05-04
TELA BIO, INC.
OviTex® 2022-04-05
TELA BIO, INC.
OviTex® 2022-04-05
TELA BIO, INC.
OviTex® 2022-02-15
TELA BIO, INC.
OviTex® PRS 2022-01-12
TELA BIO, INC.
OviTex® 2022-01-11
TELA BIO, INC.
OviTex® 2022-01-11
TELA BIO, INC.
OviTex® 2021-12-14
TELA BIO, INC.
OviTex® 2021-11-11
TELA BIO, INC.
OviTex® 2021-11-11
TELA BIO, INC.
OviTex® 2020-10-29
TELA BIO, INC.
OviTex® PRS 2020-09-22
TELA BIO, INC.
OviTex® PRS 2020-09-22
TELA BIO, INC.
OviTex® PRS 2020-09-22
TELA BIO, INC.
OviTex® PRS 2020-09-22
TELA BIO, INC.
OviTex® PRS 2020-09-22
TELA BIO, INC.
OviTex® PRS 2020-09-22
TELA BIO, INC.
OviTex® PRS 2020-05-25
TELA BIO, INC.
OviTex® PRS 2020-05-25
TELA BIO, INC.
OviTex® PRS 2020-05-25
TELA BIO, INC.
OviTex® PRS 2020-05-25
TELA BIO, INC.
OviTex® PRS 2020-05-25
TELA BIO, INC.
TELAMax F10068-04082020-03-06
TELA BIO, INC.
TELAMax 1S F10069-18222020-03-06
TELA BIO, INC.
TELAMax F10068-10102020-03-06
TELA BIO, INC. [TELA Bio]
OviTex PRS2019-05-02
TELA BIO, INC. [TELA Bio]
OviTex PRS2019-05-02
TELA BIO, INC. [TELA Bio]
OviTex Reinforced BioScaffold with Permanent Polymer (OviTex)2018-12-20
TELA BIO, INC. [TELA Bio]
OviTex Reinforced BioScaffold with Permanent Polymer (OviTex)2018-12-20
TELA BIO, INC. [TELA Bio]
OviTex Reinforced BioScaffold with Resorbable Polymer (OviTex)2018-10-22
TELA BIO, INC. [TELA Bio]
OviTex Reinforced BioScaffold with Permanent Polymer (OviTex)2018-10-22
TELA BIO, INC. [TELA Bio]
OviTex LPR Reinforced BioScaffold2018-10-22
TELA BIO, INC. [TELA Bio]
OviTex Reinforced BioScaffold with Permanent Polymer (OviTex)2018-10-22
TELA BIO, INC. [TELA Bio]
OviTex LPR Reinforced BioScaffold2018-10-22
TELA BIO, INC.
OVINE TISSUE MATRIX(OTM)2014-12-11

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