Skip to content

Company · US

TEI Biosciences, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2017. Name variants (Inc, Corp, punctuation) are merged.

16510(k) clearances (0 in 12 months)

18recalls (0 in 12 months)

17recalls that name a 510(k)

Product codes

Code	Device	Records
FTM	Mesh, Surgical	18
KGN	Wound Dressing With Animal-Derived Material(S)	12
FTL	Mesh, Surgical, Polymeric	2
FRO	Dressing, Wound, Drug	1
PAJ	Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Feb 16, 2017	K162965	SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction Tei Biosciences, Inc.	FTM
Feb 22, 2016	K153690	PriMatrix Dermal Repair Scaffold Tei Biosciences, Inc.	KGN
Aug 5, 2013	K131286	PRIMATRIX DERMAL REPAIR SCAFFOLD Tei Biosciences, Inc.	KGN
Dec 10, 2010	K100261	PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD Tei Biosciences, Inc.	FRO
Feb 4, 2009	K083898	SURGIMEND Tei Biosciences, Inc.	FTM
Dec 12, 2008	K083440	PRIMATRIX DERMAL REPAIR SCAFFOLD Tei Biosciences, Inc.	KGN
Aug 6, 2007	K071807	ORTHOMEND SOFT TISSUE MATRIX Tei Biosciences, Inc.	FTM
Jun 29, 2006	K061407	PRIMATRIX DERMAL REPAIR SCAFFOLD Tei Biosciences, Inc.	KGN
May 17, 2006	K060984	XENFORM SOFT TISSUE REPAIR MATRIX Tei Biosciences, Inc.	FTM
May 17, 2006	K060829	COSMATRIX Tei Biosciences, Inc.	FTM
May 15, 2006	K060989	TISSUEMEND SOFT TISSUE REPAIR MATRIX Tei Biosciences, Inc.	FTM
Aug 11, 2005	K051766	ORTHOMEND Tei Biosciences, Inc.	FTL
Jun 10, 2005	K051190	XENFORM SOFT TISSUE REPAIR MATRIX Tei Biosciences, Inc.	PAJ
Sep 29, 2003	K023778	DRESSSKIN Tei Biosciences, Inc.	KGN
Jun 27, 2003	K031188	ORTHOMEND Tei Biosciences, Inc.	FTL
Apr 3, 2002	K020455	TISSUEMEND SOFT TISSUE REPAIR MATRIX Tei Biosciences, Inc.	FTM

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Sep 30, 2024	TEI Biosciences, Inc. TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm. Open, Classified	FTM	K060989
Sep 30, 2024	TEI Biosciences, Inc. Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm. Open, Classified	FTM	K171357
Sep 30, 2024	TEI Biosciences, Inc. Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm. Open, Classified	FTM	K071807
Sep 30, 2024	TEI Biosciences, Inc. PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), 8x8 cm (2:1). Open, Classified	KGN	K100261
Sep 30, 2024	TEI Biosciences, Inc. PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm. Open, Classified	KGN	K100261
Sep 30, 2024	TEI Biosciences, Inc. PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm. Open, Classified	KGN	K100261
Sep 30, 2024	TEI Biosciences, Inc. PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), and 8x8 cm (2:1). Open, Classified	KGN	K153690
Sep 30, 2024	TEI Biosciences, Inc. PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1). Open, Classified	KGN	K153690
Sep 30, 2024	TEI Biosciences, Inc. PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm. Open, Classified	KGN	K153690
Sep 30, 2024	TEI Biosciences, Inc. SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm Open, Classified	FTM	None listed
Sep 30, 2024	TEI Biosciences, Inc. SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm, 20x0.5 cm, and 10x25 cm Fenestrated. Open, Classified	FTM	K083898
Sep 30, 2024	TEI Biosciences, Inc. SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25 cm, 1x5 cm, 10x25 cm 4x7cm Fenestrated, Open, Classified	FTM	K083898
Sep 30, 2024	TEI Biosciences, Inc. SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, and 25x40 cm. Open, Classified	FTM	K162965
Sep 30, 2024	TEI Biosciences, Inc. SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25cm, 10x15cm Semi-Oval, Open, Classified	FTM	K083898
Sep 30, 2024	TEI Biosciences, Inc. SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin. Open, Classified	FTM	K071807
Sep 30, 2024	TEI Biosciences, Inc. SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm Semi-Oval, 15x15 cm Semi-Oval, 8x20 cm Fenestrated, Open, Classified	FTM	K071807 K171357
Sep 30, 2024	TEI Biosciences, Inc. SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x15 cm, 1.0 10x20 cm, 1.0 16x20 cm, 1.0 13x25 cm, 1.0 4x16 cm, 1.0 3x3 cm, 1.0 4x Open, Classified	FTM	K071807
Jun 15, 2017	TEI Biosciences PriMatrix is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's need Terminated	KGN	K153690

Get alerts for these product codes