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ACELL, INC.

US

Last updated September 17, 2026

Information

Country
US
Address
6640 Eli Whitney Dr Ste 200, Columbia, MD, 21046
Website
acell.com
LinkedIn
—
Facebook
—
Phone
+1(800)826-2926
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
3005920706
DUNS Number
137258252

Catalogue (222)

Page 2 of 5
DeviceModel / ReferenceRegistriesClassStatus
MatriStem WS0710
FDA UDI
UUnknown
MatriStem MM0100F
FDA UDI
UUnknown
ACell® PFM0912
FDA UDI
Class IIUnknown
Gentrix® PSM0715
FDA UDI
Class IIActive
MediHoney® 31022
FDA UDI
UActive
Gentrix® PSMX0710
FDA UDI
Class IIActive
MatriStem BMM1015
FDA UDI
UUnknown
Cytal® BMM0710
FDA UDI
UUnknown
Gentrix® PSM0505
FDA UDI
Class IIActive
Tcc-Ez® TCC23001
FDA UDI
Class IActive
Gentrix® MSPL1015
FDA UDI
Class IIActive
MatriStem PFM0710
FDA UDI
Class IIUnknown
MatriStem PSM0710
FDA UDI
Class IIUnknown
MatriStem MM1000
FDA UDI
UUnknown
Cytal® WSX0710
FDA UDI
UActive
MediHoney® 31618
FDA UDI
UActive
MediHoney® 31045
FDA UDI
UActive
Cytal® WSM0505
FDA UDI
UActive
MatriStem PSM0505
FDA UDI
Class IIUnknown
MatriStem PSMX0412
FDA UDI
Class IIUnknown
MicroMatrix® MM0500
FDA UDI
UActive
Tcc-Ez® TCC24051
FDA UDI
Class IActive
ACell® PFM0412
FDA UDI
Class IIUnknown
MatriStem MSPL0710
FDA UDI
Class IIUnknown
Gentrix® PSMT1620B
FDA UDI
Class IIActive
Tcc-Ez® TCC24002
FDA UDI
Class IActive
MatriStem MM0200F
FDA UDI
UUnknown
Tcc-Ez® TCC2SAWSSB
EUDAMEDFDA UDI
Class IActive
MatriStem PSMT2030
FDA UDI
Class IIUnknown
MicroMatrix® MM0100
FDA UDI
UActive
MicroMatrix® MM1000
FDA UDI
UActive
MediHoney® 31620
FDA UDI
UActive
Tcc-Ez® TCC24224
FDA UDI
Class IUnknown
Cytal® BMM0505
FDA UDI
UActive
MatriStem MSPL1010
FDA UDI
Class IIUnknown
Cytal® WS0710
FDA UDI
UUnknown
MatriStem MM0100
FDA UDI
UUnknown
Gentrix® LRM0410
FDA UDI
Class IIUnknown
Tcc-Ez® TCC24016
FDA UDI
Class IUnknown
Gentrix® EXT1020
FDA UDI
Class IIUnknown
Gentrix® EXT1620
FDA UDI
Class IIUnknown
MatriStem SMRS0615
FDA UDI
Class IIUnknown
MatriStem PSMT1020
FDA UDI
Class IIUnknown
MatriStem MSPL0507
FDA UDI
Class IIUnknown
Cytal® WSM0710
FDA UDI
UUnknown
MatriStem MM0500
FDA UDI
UUnknown
MatriStem WS1015
FDA UDI
UUnknown
Tcc-Ez® TCC24214
FDA UDI
Class IActive
Cytal® WSR1625
FDA UDI
UActive
Gentrix® PSMT2030
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.

DateRecall No.ClassStatusReason
Feb 14, 2019Z-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, 2019Z-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, 2011Z-2855-2011—terminated

Surgical mesh for implantation may have elevated endotoxin levels.