TEI Biosciences, Inc.
Medical device manufacturer in Boston, MA.
16510(k) clearances
0PMA approvals
18recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K162965 | SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionFTM · Traditional | 02/16/2017SE |
| K153690 | PriMatrix Dermal Repair ScaffoldKGN · Traditional | 02/22/2016SE |
| K131286 | Primatrix Dermal Repair ScaffoldKGN · Traditional | 08/05/2013SE |
| K100261 | Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldFRO · Abbreviated | 12/10/2010SE |
| K083898 | SurgimendFTM · Special | 02/04/2009SE |
| K083440 | Primatrix Dermal Repair ScaffoldKGN · Special | 12/12/2008SE |
| K071807 | Orthomend Soft Tissue MatrixFTM · Special | 08/06/2007SE |
| K061407 | Primatrix Dermal Repair ScaffoldKGN · Special | 06/29/2006SE |
| K060984 | Xenform Soft Tissue Repair MatrixFTM · Special | 05/17/2006SE |
| K060829 | CosmatrixFTM · Abbreviated | 05/17/2006SE |
| K060989 | Tissuemend Soft Tissue Repair MatrixFTM · Special | 05/15/2006SE |
| K051766 | OrthomendFTL · Abbreviated | 08/11/2005SE |
| K051190 | Xenform Soft Tissue Repair MatrixPAJ · Special | 06/10/2005SE |
| K023778 | DressskinKGN · Abbreviated | 09/29/2003SE |
| K031188 | OrthomendFTL · Abbreviated | 06/27/2003SE |
| K020455 | Tissuemend Soft Tissue Repair MatrixFTM · Abbreviated | 04/03/2002SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2085-2023 Class II | TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | 05/23/2023Open, Classified |
| Z-2084-2023 Class II | Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | 05/23/2023Open, Classified |
| Z-2083-2023 Class II | Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | 05/23/2023Open, Classified |
| Z-2082-2023 Class II | PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | 05/23/2023Open, Classified |
| Z-2081-2023 Class II | PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | 05/23/2023Open, Classified |
| Z-2080-2023 Class II | PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | 05/23/2023Open, Classified |
| Z-2079-2023 Class II | PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1)…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | 05/23/2023Open, Classified |
| Z-2078-2023 Class II | PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | 05/23/2023Open, Classified |
| Z-2077-2023 Class II | PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | 05/23/2023Open, Classified |
| Z-2076-2023 Class II | SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | 05/23/2023Open, Classified |
| Z-2075-2023 Class II | SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | 05/23/2023Open, Classified |
| Z-2074-2023 Class II | SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | 05/23/2023Open, Classified |
| Z-2073-2023 Class II | SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | 05/23/2023Open, Classified |
| Z-2072-2023 Class II | SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | 05/23/2023Open, Classified |
| Z-2071-2023 Class II | SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | 05/23/2023Open, Classified |
| Z-2070-2023 Class II | SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | 05/23/2023Open, Classified |
| Z-2069-2023 Class II | SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | 05/23/2023Open, Classified |
| Z-0383-2018 Class II | PriMatrix is an acellular dermal tissue matrix derived from fetal bovine dermis. The…During Final Assembly Operation, it was noticed that some of the PriMatrix Instructions for Use (IFUs) from… | 06/15/2017Terminated |