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 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list ACell with 20 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Jul 11, 2024: Cytal® Wound Matrix; Cytal® Burn Matrix.
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.
| Jul 11, 2024 | Cytal® Wound Matrix; Cytal® Burn MatrixK241724 · KGN | 510(k) clearances |
| Jul 11, 2024 | MicroMatrix® UBM ParticulateK241706 · KGN | 510(k) clearances |
| Sep 22, 2023 | MicroMatrix® FlexK230980 · KGN | 510(k) clearances |
| Nov 22, 2019 | MatriStem UBM Pericardial PatchK191734 · PSQ | 510(k) clearances |
| Oct 25, 2019 | Cytal Wound Matrix 3-LayerK192725 · KGN | 510(k) clearances |
| Feb 14, 2019 | Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended forClass II · The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification f | Device recalls |
| Feb 14, 2019 | Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended forClass II · The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification f | Device recalls |
| Feb 7, 2019 | Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalK182259 · FTM | 510(k) clearances |
| May 11, 2018 | Cytal Wound ParticulateK180776 · KGN | 510(k) clearances |
| Oct 6, 2017 | MicroMatrixK172399 · 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
