Medical Device Manufacturer · US , Boston , MA

Tei Biosciences, Inc. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2002

Recent clearances: SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction, PriMatrix Dermal Repair Scaffold, PRIMATRIX DERMAL REPAIR SCAFFOLD

16
Total
16
Cleared
0
Denied

Tei Biosciences, Inc. has 16 FDA 510(k) cleared general & plastic surgery devices. Based in Boston, US.

Historical record: 16 cleared submissions from 2002 to 2017.

Browse the complete list of FDA 510(k) cleared general & plastic surgery devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Integra Lifesciences Corp (Owner of Tei Biosciences) and Integra Lifesciences Corporation (Owner of Tei Biosciences).

FDA 510(k) Regulatory Record - Tei Biosciences, Inc.

16 devices
1-16 of 16
Cleared Feb 16, 2017
SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction
K162965 · FTM
General & Plastic Surgery · 115d
Cleared Feb 22, 2016
PriMatrix Dermal Repair Scaffold
K153690 · KGN
General & Plastic Surgery · 61d
Cleared Aug 05, 2013
PRIMATRIX DERMAL REPAIR SCAFFOLD
K131286 · KGN
General & Plastic Surgery · 91d
Cleared Dec 10, 2010
PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD
K100261 · FRO
General & Plastic Surgery · 316d
Cleared Feb 04, 2009
SURGIMEND
K083898 · FTM
General & Plastic Surgery · 37d
Cleared Dec 12, 2008
PRIMATRIX DERMAL REPAIR SCAFFOLD
K083440 · KGN
General & Plastic Surgery · 22d
Cleared Aug 06, 2007
ORTHOMEND SOFT TISSUE MATRIX
K071807 · FTM
General & Plastic Surgery · 35d
Cleared Jun 29, 2006
PRIMATRIX DERMAL REPAIR SCAFFOLD
K061407 · KGN
General & Plastic Surgery · 38d
Cleared May 17, 2006
COSMATRIX
K060829 · FTM
General & Plastic Surgery · 51d
Cleared May 17, 2006
XENFORM SOFT TISSUE REPAIR MATRIX
K060984 · FTM
General & Plastic Surgery · 37d
Cleared May 15, 2006
TISSUEMEND SOFT TISSUE REPAIR MATRIX
K060989 · FTM
General & Plastic Surgery · 35d
Cleared Aug 11, 2005
ORTHOMEND
K051766 · FTL
General & Plastic Surgery · 42d
Cleared Jun 10, 2005
XENFORM SOFT TISSUE REPAIR MATRIX
K051190 · PAJ
Obstetrics & Gynecology · 31d
Cleared Sep 29, 2003
DRESSSKIN
K023778 · KGN
General & Plastic Surgery · 321d
Cleared Jun 27, 2003
ORTHOMEND
K031188 · FTL
General & Plastic Surgery · 73d
Cleared Apr 03, 2002
TISSUEMEND SOFT TISSUE REPAIR MATRIX
K020455 · FTM
General & Plastic Surgery · 51d
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