Tepha Inc

FDA Filings

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

FDA Registration(s)
Registration Number3005670760
FEI Number3005670760
NameTepha, Incorporated
Owner & OperatorTepha Inc.
Contact Address99 Hayden Ave, Suite 360
Lexington MA 02421 US
Official Correspondent
  • Barbara M Rinaldi
  • 1-781-3571700-758
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address99 Hayden Avenue, Suite 360
Lexington, MA 02421 US
Establishment Type
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Tepha, Inc.
GalaSTITCH Absorbable Monofilament Suture2021-05-27
Tepha, Inc.
GalaFORM 3D CEFR012020-10-21
Tepha, Inc.
GalaFLEX 3D CESH142020-10-07
Tepha, Inc.
GalaFLEX 3D CESH132020-10-07
Tepha, Inc.
GalaFLEX 3D CESH122020-10-07
Tepha, Inc.
GalaFLEX 3D CESH112020-10-07
Tepha, Inc.
GalaFLEX 3D CESH102020-10-07
Tepha, Inc.
GalaFLEX 3D CESH092020-10-07
Tepha, Inc.
GalaFLEX 3D CESH082020-10-07
Tepha, Inc.
GalaFLEX 3D CESH072020-10-07
Tepha, Inc.
GalaFLEX 3D CESH062020-10-07
Tepha, Inc.
GalaFLEX 3D CESH052020-10-07
Tepha, Inc.
GalaFLEX 3D CESH042020-10-07
Tepha, Inc.
GalaFLEX 3D CESH032020-10-07
Tepha, Inc.
GalaFLEX 3D CESH022020-10-07
Tepha, Inc.
GalaFLEX 3D CESH012020-10-07
Tepha, Inc.
GalaFLEX 3D SH3D142020-10-07
Tepha, Inc.
GalaFLEX 3D SH3D132020-10-07
Tepha, Inc.
GalaFLEX 3D SH3D122020-10-07
Tepha, Inc.
GalaFLEX 3D SH3D112020-10-07
Tepha, Inc.
GalaFLEX 3D SH3D102020-10-07
Tepha, Inc.
GalaFLEX 3D SH3D092020-10-07
Tepha, Inc.
GalaFLEX 3D SH3D082020-10-07
Tepha, Inc.
GalaFLEX 3D SH3D072020-10-07
Tepha, Inc.
GalaFLEX 3D SH3D062020-10-07
Tepha, Inc.
GalaFLEX 3D SH3D052020-10-07
Tepha, Inc.
GalaFLEX 3D SH3D042020-10-07
Tepha, Inc.
GalaFLEX 3D SH3D032020-10-07
Tepha, Inc.
GalaFLEX 3D SH3D022020-10-07
Tepha, Inc.
GalaFLEX 3D SH3D012020-10-07
Tepha, Inc.
GalaFLEX 3DR CEFR142020-10-07
Tepha, Inc.
GalaFLEX 3DR CEFR132020-10-07
Tepha, Inc.
GalaFLEX 3DR CEFR122020-10-07
Tepha, Inc.
GalaFLEX 3DR CEFR112020-10-07
Tepha, Inc.
GalaFLEX 3DR CEFR102020-10-07
Tepha, Inc.
GalaFLEX 3DR CEFR092020-10-07
Tepha, Inc.
GalaFLEX 3DR CEFR072020-10-07
Tepha, Inc.
GalaFLEX 3DR CEFR062020-10-07
Tepha, Inc.
GalaFLEX 3DR CEFR052020-10-07
Tepha, Inc.
GalaFLEX 3DR CEFR042020-10-07
Tepha, Inc.
GalaFLEX 3DR CEFR032020-10-07
Tepha, Inc.
GalaFLEX 3DR CEFR022020-10-07
Tepha, Inc.
GalaFLEX 3DR CEFR012020-10-07
Tepha, Inc.
GalaFLEX 3DR FR3D142020-10-07
Tepha, Inc.
GalaFLEX 3DR FR3D132020-10-07
Tepha, Inc.
GalaFLEX 3DR FR3D122020-10-07
Tepha, Inc.
GalaFLEX 3DR FR3D112020-10-07
Tepha, Inc.
GalaFLEX 3DR FR3D102020-10-07
Tepha, Inc.
GalaFLEX 3DR FR3D092020-10-07
Tepha, Inc.
GalaFLEX 3DR FR3D072020-10-07
Tepha, Inc.
GalaFLEX 3DR FR3D062020-10-07
Tepha, Inc.
GalaFLEX 3DR FR3D052020-10-07
Tepha, Inc.
GalaFLEX 3DR FR3D042020-10-07
Tepha, Inc.
GalaFLEX 3DR FR3D032020-10-07
Tepha, Inc.
GalaFLEX 3DR FR3D022020-10-07
Tepha, Inc.
GalaFLEX 3DR FR3D012020-10-07
Tepha, Inc.
GalaFORM 3D CEFR142020-08-26
Tepha, Inc.
GalaFORM 3D CEFR132020-08-26
Tepha, Inc.
GalaFORM 3D CEFR122020-08-26
Tepha, Inc.
GalaFORM 3D CEFR112020-08-26
Tepha, Inc.
GalaFORM 3D CEFR102020-08-26
Tepha, Inc.
GalaFORM 3D CEFR092020-08-26
Tepha, Inc.
GalaFORM 3D CEFR072020-08-26
Tepha, Inc.
GalaFORM 3D CEFR062020-08-26
Tepha, Inc.
GalaFORM 3D CEFR052020-08-26
Tepha, Inc.
GalaFORM 3D CEFR042020-08-26
Tepha, Inc.
GalaFORM 3D CEFR032020-08-26
Tepha, Inc.
GalaFORM 3D CEFR022020-08-26
Tepha, Inc.
GalaFLEX CE01042020-08-26
Tepha, Inc.
GalaFLEX CE017M2020-08-26
Tepha, Inc.
GalaFLEX CE017S2020-08-26
Tepha, Inc.
GalaFLEX CE013M2020-08-26
Tepha, Inc.
GalaFLEX CE013S2020-08-26
Tepha, Inc.
GalaFLEX CE019M2020-08-26
Tepha, Inc.
GalaFLEX CE019S2020-08-26
Tepha, Inc.
GalaFLEX CE016M2020-08-26
Tepha, Inc.
GalaFLEX CE016S2020-08-26
Tepha, Inc.
GalaFLEX CE02082020-08-26
Tepha, Inc.
GalaFLEX CE02062020-08-26
Tepha, Inc.
GalaFLEX CE01032020-08-26
Tepha, Inc.
GalaSHAPE 3D CESH142020-08-26
Tepha, Inc.
GalaSHAPE 3D CESH132020-08-26
Tepha, Inc.
GalaSHAPE 3D CESH122020-08-26
Tepha, Inc.
GalaSHAPE 3D CESH112020-08-26
Tepha, Inc.
GalaSHAPE 3D CESH102020-08-26
Tepha, Inc.
GalaSHAPE 3D CESH092020-08-26
Tepha, Inc.
GalaSHAPE 3D CESH082020-08-26
Tepha, Inc.
GalaSHAPE 3D CESH072020-08-26
Tepha, Inc.
GalaSHAPE 3D CESH062020-08-26
Tepha, Inc.
GalaSHAPE 3D CESH042020-08-26
Tepha, Inc.
GalaSHAPE 3D CESH022020-08-26
Tepha, Inc.
GalaFLEX CE06082020-04-17
Tepha, Inc.
GalaFLEX CE04082020-04-17
Tepha, Inc.
GalaSHAPE 3D CESH052020-02-12
Tepha, Inc.
GalaSHAPE 3D CESH032020-02-12
Tepha, Inc.
GalaSHAPE 3D CESH012020-02-12
Tepha, Inc.
GalaFLEX Scaffold GP06082018-07-06
Tepha, Inc.
GalaFLEX Scaffold GP04082018-07-06
Tepha, Inc.
GalaFLEX Scaffold GP02082018-07-06
Tepha, Inc.
GalaFLEX Scaffold GP02062018-07-06
Tepha, Inc.
GalaFLEX Scaffold GP01032018-07-06
Tepha, Incorporated [Tepha Inc.]
GalaFORM 3D2017-03-29
TEPHA, INC.
GalaFORM 3D2017-02-23
Tepha, Incorporated [Tepha Inc.]
GalaSHAPE 3D2016-09-13
Tepha, Inc.
GalaSHAPE 3D2016-08-23
Tepha, Incorporated [Tepha Inc.]
GalaFLEX Scaffold2015-12-17
TEPHA, INC.
GALAFLEX MESH2014-05-21
Tepha, Incorporated [Tepha Inc.]
TephaFLEX Braided Suture2013-10-25
TEPHA, INC.
TEPHAFLEX BRAIDED SUTURE2013-09-05
Tepha, Incorporated [Tepha Inc.]
TephaFLEX Melt Blown Matrix2013-07-31
TEPHA, INC.
TEPHAFLEX MELTBLOWN CONSTRUCT2013-05-07
Tepha, Incorporated [Tepha Inc.]
TephaFLEX Absorbable Suture2012-06-04
Tepha, Incorporated [Tepha Inc.]
TephaFLEX Surgical Mesh2012-03-28
Tepha, Incorporated [Tepha Inc.]
GalaFLEX Mesh2012-03-28
Tepha, Incorporated [Tepha Inc.]
TephaFLEX Light Mesh2012-03-28
TEPHA, INC.
TEPHAFLEX MESH2012-02-15
TEPHA, INC.
TEPHAFLEX LIGHT MESH2012-02-15
Tepha, Incorporated [Tepha Inc.]
TephaFLEX Surgical Mesh2011-11-18
Tepha, Incorporated [Tepha Inc.]
GalaFLEX mesh2011-11-18
TEPHA, INC.
TEPHAFLEX MESH2011-09-26
Tepha, Incorporated [Tepha Inc.]
TephaFLEX Composite Mesh2010-11-15
Tepha, Incorporated [Tepha Inc.]
TephaFLEX Composite Mesh2010-11-15
Tepha, Incorporated [Tepha Inc.]
TephaFLEX Composite Mesh2010-11-15
Tepha, Incorporated [Tepha Inc.]
TephaFLEX Composite Mesh2010-11-15
TEPHA, INC.
TEPHAFLEX COMPOSITE MESH2010-08-30
Tepha, Incorporated [Tepha Inc.]
TephaFLEX Surgical Film2009-11-09
Tepha, Incorporated [Tepha Inc.]
TephaFLEX Surgical Film2009-11-09
Tepha, Incorporated [Tepha Inc.]
TephaFLEX Absorbable Suture2009-11-09
TEPHA, INC.
TEPHAFLEX SURGICAL FILM2009-08-07
TEPHA, INC.
TEPHAFLEX ABSORBABLE SUTURE2008-10-30
Tepha, Incorporated [Tepha Inc.]
TephaFLEX Surgical Film2008-10-23
Tepha, Incorporated [Tepha Inc.]
TephaFLEX Surgical Film2008-10-23
TEPHA, INC.
TEPHAFLEX ABSORBABLE SUTURE2008-07-15
TEPHA, INC.
TEPHAFLEX SURGICAL FILM2007-11-29
Tepha, Incorporated [Tepha Inc.]
TephaFLEX Surgical Mesh2007-11-01
Tepha, Incorporated [Tepha Inc.]
TephaFLEX Surgical Mesh2007-11-01
Tepha, Incorporated [Tepha Inc.]
TephaFLEX Absorbable Suture2007-11-01
TEPHA, INC.
TEPHAFLEX SURGICAL MESH2007-04-13
TEPHA, INC.
TEPHAFLEX ABSORBABLE SUTURE2007-02-08

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