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Sign in to claim this brandACELL, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 6640 Eli Whitney Dr Ste 200, Columbia, MD, 21046
- Website
- acell.com
- —
- —
- [email protected]
- Phone
- +1(800)826-2926
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3005920706
- DUNS Number
- 137258252
Catalogue (222)
Page 5 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MediHoney® | 31012 | FDA UDI | U | Active |
| Tcc-Ez® | TCC21131 | FDA UDI | Class I | Active |
| Cytal Wound Particulate | K180776 | FDA 510(k) | U | Active |
| Matristem Wound Matrix | K112409 | FDA 510(k) | U | Active |
| Acell Matristem Wound Sheet | K092926 | FDA 510(k) | U | Active |
| Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix | K141084 | FDA 510(k) | Class II | Active |
| MicroMatrix® UBM Particulate | K241706 | FDA 510(k) | U | Active |
| Gentrix Surgical Matrix | K162554 | FDA 510(k) | Class II | Active |
| Cytal Wound Matrix 3-Layer | K192725 | FDA 510(k) | U | Active |
| Acell Ubm Hydrated Wound Dressing | K022854 | FDA 510(k) | U | Active |
| Acell Ubm Lyophilized Wound Dressing | K021637 | FDA 510(k) | U | Active |
| MicroMatrix® Flex | K230980 | FDA 510(k) | U | Active |
| Acell Ubm Surgical Mesh Ml And Mlplus | K041140 | FDA 510(k) | Class II | Active |
| MicroMatrix | K172399 | FDA 510(k) | U | Active |
| Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal | K182259 | FDA 510(k) | Class II | Active |
| Cytal® Wound Matrix; Cytal® Burn Matrix | K241724 | FDA 510(k) | U | Active |
| Cytal Wound Matrix | K152721 | FDA 510(k) | U | Active |
| Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend | K170763 | FDA 510(k) | Class II | Active |
| Acell Powder Wound Dressing | K060888 | FDA 510(k) | U | Active |
| MicroMatrix | K153754 | FDA 510(k) | U | Active |
| Acell Ubm Surgical Mesh | K040621 | FDA 510(k) | Class II | Active |
| MatriStem UBM Pericardial Patch | K191734 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 14, 2019 | Z-1033-2019 | — | terminated | The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release. |
| Feb 14, 2019 | Z-1032-2019 | — | terminated | The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release. |
| Jul 7, 2011 | Z-2855-2011 | — | terminated | Surgical mesh for implantation may have elevated endotoxin levels. |