Acell, Inc.
Acell, Inc. holds FDA 510(k) medical device clearances, first cleared 2002, most recent 2024, with 2 FDA device recalls on record.
Top product codes for Acell, Inc.
FDA recalls by Acell, Inc.
- Z-1032-2019 — Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.
- Z-1033-2019 — Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.
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 Acell, Inc.
- K241706 — MicroMatrix® UBM Particulate
- K241724 — Cytal® Wound Matrix; Cytal® Burn Matrix
- K230980 — MicroMatrix® Flex
- K191734 — MatriStem UBM Pericardial Patch
- K192725 — Cytal Wound Matrix 3-Layer
- K182259 — Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal
- K180776 — Cytal Wound Particulate
- K172399 — MicroMatrix
- K170763 — Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend
- K162554 — Gentrix Surgical Matrix
- K153754 — MicroMatrix
- K152721 — Cytal Wound Matrix
- K141084 — Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix
- K112409 — MATRISTEM WOUND MATRIX
- K092926 — ACELL MATRISTEM WOUND SHEET
- K060888 — ACELL POWDER WOUND DRESSING
- K041140 — ACELL UBM SURGICAL MESH ML AND MLPLUS
- K040621 — ACELL UBM SURGICAL MESH
- K022854 — ACELL UBM HYDRATED WOUND DRESSING
- K021637 — ACELL UBM LYOPHILIZED WOUND DRESSING
Data sourced from openFDA. This site is unofficial and independent of the FDA.