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TEI Biosciences, Inc.

17 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 recall (Z-2069-2023)TEI Biosciences, Inc.2024-09-30
SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Sem recall (Z-2070-2023)TEI Biosciences, Inc.2024-09-30
SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thi recall (Z-2071-2023)TEI Biosciences, Inc.2024-09-30
SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 recall (Z-2072-2023)TEI Biosciences, Inc.2024-09-30
SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x recall (Z-2073-2023)TEI Biosciences, Inc.2024-09-30
SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 recall (Z-2074-2023)TEI Biosciences, Inc.2024-09-30
SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 recall (Z-2075-2023)TEI Biosciences, Inc.2024-09-30
SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x recall (Z-2076-2023)TEI Biosciences, Inc.2024-09-30
PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, recall (Z-2077-2023)TEI Biosciences, Inc.2024-09-30
PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm recall (Z-2078-2023)TEI Biosciences, Inc.2024-09-30
PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 recall (Z-2079-2023)TEI Biosciences, Inc.2024-09-30
PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, recall (Z-2080-2023)TEI Biosciences, Inc.2024-09-30
PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 c recall (Z-2081-2023)TEI Biosciences, Inc.2024-09-30
PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1) recall (Z-2082-2023)TEI Biosciences, Inc.2024-09-30
Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, recall (Z-2083-2023)TEI Biosciences, Inc.2024-09-30
Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 recall (Z-2084-2023)TEI Biosciences, Inc.2024-09-30
TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm recall (Z-2085-2023)TEI Biosciences, Inc.2024-09-30

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Every clearance here is in the API, with alerts when new ones post.