Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Integra LifeSciencesLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list TEI Biosciences with 18 device recalls, 16 510(k) clearances and 1 warning letter. The most recent is a warning letter dated Mar 6, 2019: Warning letter: Sterility assurance, Cleaning validation, Process validation.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 6, 2019 | Warning letter: Sterility assurance, Cleaning validation, Process validationCDRH | Warning letters |
| Jun 15, 2017 | PriMatrix¿ is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to beClass II · During Final Assembly Operation, it was noticed that some of the PriMatrix Instructions for Use (IFUs) from Lot RM160801 | Device recalls |
| Feb 16, 2017 | SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionK162965 · FTM | 510(k) clearances |
| Feb 22, 2016 | PriMatrix Dermal Repair ScaffoldK153690 · KGN | 510(k) clearances |
| Aug 5, 2013 | PRIMATRIX DERMAL REPAIR SCAFFOLDK131286 · KGN | 510(k) clearances |
| Dec 10, 2010 | PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLDK100261 · FRO | 510(k) clearances |
| Feb 4, 2009 | SURGIMENDK083898 · FTM | 510(k) clearances |
| Dec 12, 2008 | PRIMATRIX DERMAL REPAIR SCAFFOLDK083440 · KGN | 510(k) clearances |
| Aug 6, 2007 | ORTHOMEND SOFT TISSUE MATRIXK071807 · FTM | 510(k) clearances |
| Jun 29, 2006 | PRIMATRIX DERMAL REPAIR SCAFFOLDK061407 · KGN | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
