Tei Biosciences, Inc.
Tei Biosciences, Inc. holds FDA 510(k) medical device clearances, first cleared 2002, most recent 2017, with 17 FDA device recalls on record.
Top product codes for Tei Biosciences, Inc.
FDA recalls by Tei Biosciences, Inc.
10 most recent of 17- Z-2082-2023 — 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).
- Z-2070-2023 — 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, 10x15 cm Slant Fenestrated, 7x17 cm Semi-Oval, 8x16 cm Thin Semi-Oval, 10x20 cm Thin Semi-Oval, 6x16 cm Semi-Oval, Thin Oval 8x12 cm, Thin Oval 10x15 cm, Meshed 20cm x 10cm
- Z-2081-2023 — PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
- Z-2083-2023 — Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.
- Z-2074-2023 — 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, and 10x25 cm Fenestrated.
- Z-2078-2023 — 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).
- Z-2073-2023 — 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.
- Z-2069-2023 — 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 4x7 cm, 1.0 4x12 cm, 1.0 6x16 cm, 1.0 25x40 cm, 1.0 20 x 30 cm, 1.0 8x16 cm, 1.0 4x7 cm Thin, 1.0 5x6 cm Thin, 1.0 3x3 cm Thin, 1.0 0.3x25 cm, 1.0 0.6x25 cm, 1.0 1x25 cm.
- Z-2077-2023 — 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.
- Z-2084-2023 — Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Tei Biosciences, Inc.
- K162965 — SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction
- K153690 — PriMatrix Dermal Repair Scaffold
- K131286 — PRIMATRIX DERMAL REPAIR SCAFFOLD
- K100261 — PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD
- K083898 — SURGIMEND
- K083440 — PRIMATRIX DERMAL REPAIR SCAFFOLD
- K071807 — ORTHOMEND SOFT TISSUE MATRIX
- K061407 — PRIMATRIX DERMAL REPAIR SCAFFOLD
- K060829 — COSMATRIX
- K060984 — XENFORM SOFT TISSUE REPAIR MATRIX
- K060989 — TISSUEMEND SOFT TISSUE REPAIR MATRIX
- K051766 — ORTHOMEND
- K051190 — XENFORM SOFT TISSUE REPAIR MATRIX
- K023778 — DRESSSKIN
- K031188 — ORTHOMEND
- K020455 — TISSUEMEND SOFT TISSUE REPAIR MATRIX
Data sourced from openFDA. This site is unofficial and independent of the FDA.