This page includes the latest FDA filings for Acell Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3005920706 |
| FEI Number | 3005920706 |
| Name | ACELL, INC. |
| Owner & Operator | ACell, Inc. |
| Contact Address | 6640 Eli Whitney Drive Suite 200 Columbia MD 21046 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 6640 Eli Whitney Dr Ste 200 Columbia, MD 21046 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
| Registration Number | 3004555298 |
| FEI Number | 3004555298 |
| Name | ACell, Inc. |
| Owner & Operator | ACell, Inc. |
| Contact Address | 6640 Eli Whitney Drive Suite 200 Columbia MD 21046 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 3589 Sagamore Parkway North, Suite 220 Lafayette, IN 47904 US |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| ACELL, INC. | MicroMatrix® MMFX05 | 2023-10-10 |
| ACELL, INC. | MEDIHONEY® Hydrogel DUP31740 | 2023-06-08 |
| ACELL, INC. | MEDIHONEY® HCS DUP31744 | 2023-06-08 |
| ACELL, INC. | MediHoney® 31644 | 2023-05-12 |
| ACELL, INC. | MediHoney® 31805 | 2023-05-11 |
| ACELL, INC. | Gentrix® PSMT1020 | 2020-08-31 |
| ACELL, INC. | Gentrix® PSMT1620 | 2020-08-31 |
| ACELL, INC. | Cardion™ | 2020-08-21 |
| ACELL, INC. | Cardion™ | 2020-08-21 |
| ACELL, INC. | Cardion™ | 2020-08-10 |
| ACELL, INC. | Cytal® WSR1635 | 2020-05-06 |
| ACELL, INC. | Cytal® WSR1625 | 2020-05-06 |
| ACELL, INC. | Cytal WSX1015 | 2020-05-06 |
| ACELL, INC. | Cytal WSX0710 | 2020-05-06 |
| ACELL, INC. | Cytal WSX0505 | 2020-05-06 |
| ACELL, INC. | Cytal WSR1015 | 2020-05-06 |
| ACELL, INC. | Cytal WSR0710 | 2020-05-06 |
| ACELL, INC. | Cytal WSR0505 | 2020-05-06 |
| ACELL, INC. | Cytal WSM1015 | 2020-05-06 |
| ACELL, INC. | Cytal WSM0710 | 2020-05-06 |
| ACELL, INC. | Cytal WSM0505 | 2020-05-06 |
| ACELL, INC. | Cytal WS1015 | 2020-05-06 |
| ACELL, INC. | Cytal WS0710 | 2020-05-06 |
| ACELL, INC. | Cytal WS0307 | 2020-05-06 |
| ACELL, INC. | Cytal WS0303 | 2020-05-06 |
| ACELL, INC. | MicroMatrix® MM1000 | 2020-05-06 |
| ACELL, INC. | MicroMatrix® MM0200F | 2020-05-06 |
| ACELL, INC. | MicroMatrix® MM0500 | 2020-05-06 |
| ACELL, INC. | MicroMatrix® MM0200 | 2020-05-06 |
| ACELL, INC. | MicroMatrix® MM0100F | 2020-05-06 |
| ACELL, INC. | MicroMatrix® MM0100 | 2020-05-06 |
| ACELL, INC. | MicroMatrix® MM0060 | 2020-05-06 |
| ACELL, INC. | MicroMatrix® MM0030 | 2020-05-06 |
| ACELL, INC. | MicroMatrix® MM0020 | 2020-05-06 |
| ACELL, INC. | Cytal BMM1015 | 2020-05-06 |
| ACELL, INC. | Cytal BMM0710 | 2020-05-06 |
| ACELL, INC. | Cytal BMM0505 | 2020-05-06 |
| ACELL, INC. | Cytal WS1015 | 2020-05-06 |
| ACELL, INC. | Cytal WS0710 | 2020-05-06 |
| ACELL, INC. | Cytal WS0307 | 2020-05-06 |
| ACELL, INC. | Cytal WS0303 | 2020-05-06 |
| ACELL, INC. | Cytal WSM1015 | 2020-05-06 |
| ACELL, INC. | Cytal WSM0710 | 2020-05-06 |
| ACELL, INC. | Cytal WSM0505 | 2020-05-06 |
| ACELL, INC. | Cytal BMM0505 | 2020-05-06 |
| ACELL, INC. | Cytal BMM0710 | 2020-05-06 |
| ACELL, INC. | Cytal BMM1015 | 2020-05-06 |
| ACELL, INC. | Cytal WSX1015 | 2020-05-06 |
| ACELL, INC. | Cytal WSX0710 | 2020-05-06 |
| ACELL, INC. | Cytal WSX0505 | 2020-05-06 |
| ACELL, INC. | Cytal WSR1015 | 2020-05-06 |
| ACELL, INC. | Cytal WSR0710 | 2020-05-06 |
| ACELL, INC. | Cytal WSR0505 | 2020-05-06 |
| ACELL, INC. | MatriStem WSM1015 | 2020-05-06 |
| ACELL, INC. | MatriStem WSM0710 | 2020-05-06 |
| ACELL, INC. | MatriStem WSM0505 | 2020-05-06 |
| ACELL, INC. | MatriStem BMM1015 | 2020-05-06 |
| ACELL, INC. | MatriStem BMM0710 | 2020-05-06 |
| ACELL, INC. | MatriStem BMM0505 | 2020-05-06 |
| ACELL, INC. | MatriStem MM1000 | 2020-05-06 |
| ACELL, INC. | MatriStem MM0500 | 2020-05-06 |
| ACELL, INC. | MatriStem MM0200F | 2020-05-06 |
| ACELL, INC. | MatriStem MM0200 | 2020-05-06 |
| ACELL, INC. | MatriStem MM0100F | 2020-05-06 |
| ACELL, INC. | MatriStem MM0100 | 2020-05-06 |
| ACELL, INC. | MatriStem MM0060 | 2020-05-06 |
| ACELL, INC. | MatriStem WS1015 | 2020-05-06 |
| ACELL, INC. | MatriStem WS0710 | 2020-05-06 |
| ACELL, INC. | MatriStem WS0307 | 2020-05-06 |
| ACELL, INC. | MatriStem WS0303 | 2020-05-06 |
| ACELL, INC. | MatriStem MM0030 | 2020-05-06 |
| ACELL, INC. | MatriStem MM0020 | 2020-05-06 |
Acell, Inc. | MatriStem UBM Pericardial Patch | 2019-11-22 |
ACELL, INC. | Cytal Wound Matrix 3-Layer | 2019-11-22 |
| ACELL, INC. | Gentrix® PSMT1020 | 2019-11-18 |
| ACELL, INC. | Gentrix® PSMT1620 | 2019-11-18 |
| ACELL, INC. | Gentrix PSMT3040 | 2019-11-18 |
| ACELL, INC. | Gentrix PSMT3030 | 2019-11-18 |
| ACELL, INC. | Gentrix PSMT2030 | 2019-11-18 |
| ACELL, INC. | Gentrix PSMT2025 | 2019-11-18 |
| ACELL, INC. | Gentrix PSMT2020 | 2019-11-18 |
| ACELL, INC. | Gentrix PSMT1620 | 2019-11-18 |
| ACELL, INC. | Gentrix PSMT1020 | 2019-11-18 |
ACell, Inc. | Cytal Wound Matrix 3-Layer | 2019-10-25 |
| ACELL, INC. | Gentrix® MSPL1015 | 2019-03-11 |
| ACELL, INC. | Gentrix® MSPL1010 | 2019-03-11 |
| ACELL, INC. | Gentrix® MSPL0710 | 2019-03-11 |
| ACELL, INC. | Gentrix® MSPL0507 | 2019-03-11 |
| ACELL, INC. | Gentrix® PSM1015 | 2019-03-11 |
| ACELL, INC. | Gentrix® PSM0715 | 2019-03-11 |
| ACELL, INC. | Gentrix® PSM0710 | 2019-03-11 |
| ACELL, INC. | Gentrix® PSM0615 | 2019-03-11 |
| ACELL, INC. | Gentrix® PSM0412 | 2019-03-11 |
| ACELL, INC. | Gentrix® PSMX1015 | 2019-03-11 |
| ACELL, INC. | Gentrix® PSM0505 | 2019-03-11 |
| ACELL, INC. | Gentrix® PSMX0710 | 2019-03-11 |
| ACELL, INC. | Gentrix® PSMX0505 | 2019-03-11 |
| ACELL, INC. | Gentrix® HIAT0706 | 2019-03-11 |
| ACELL, INC. | MatriStem PSMX0816 | 2019-02-27 |
| ACELL, INC. | MatriStem PSMX0615 | 2019-02-22 |
| ACELL, INC. | MatriStem PSM0710 | 2019-02-22 |
| ACELL, INC. | MatriStem PSM0615 | 2019-02-18 |
| ACELL, INC. | MatriStem PSM0505 | 2019-02-18 |
ACell, Inc. | Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal | 2019-02-07 |
ACell, Inc. | Gentrix? Surgical Matrix | 2019-02-07 |
ACell, Inc. | Gentrix? Surgical Matrix Thin | 2019-02-07 |
ACell, Inc. | Gentrix? Surgical Matrix Plus | 2019-02-07 |
ACell, Inc. | Gentrix? Surgical Matrix Hiatal | 2019-02-07 |
ACELL, INC. | Gentrix? Surgical Matrix | 2019-02-07 |
ACELL, INC. | Gentrix? Surgical Matrix Thin | 2019-02-07 |
ACELL, INC. | Gentrix? Surgical Matrix Plus | 2019-02-07 |
ACELL, INC. | Gentrix? Surgical Matrix Hiatal | 2019-02-07 |
ACell, Inc. | Gentrix? Surgical Matrix | 2019-02-07 |
ACell, Inc. | Gentrix? Surgical Matrix Thin | 2019-02-07 |
ACell, Inc. | Gentrix? Surgical Matrix Plus | 2019-02-07 |
ACell, Inc. | Gentrix? Surgical Matrix Hiatal | 2019-02-07 |
ACELL, INC. | Gentrix? Surgical Matrix | 2019-02-07 |
ACELL, INC. | Gentrix? Surgical Matrix Thin | 2019-02-07 |
ACELL, INC. | Gentrix? Surgical Matrix Plus | 2019-02-07 |
ACELL, INC. | Gentrix? Surgical Matrix Hiatal | 2019-02-07 |
ACell, Inc. | Gentrix? Surgical Matrix | 2019-02-07 |
ACell, Inc. | Gentrix? Surgical Matrix Thin | 2019-02-07 |
ACell, Inc. | Gentrix? Surgical Matrix Plus | 2019-02-07 |
ACell, Inc. | Gentrix? Surgical Matrix Hiatal | 2019-02-07 |
ACELL, INC. | Gentrix? Surgical Matrix | 2019-02-07 |
ACELL, INC. | Gentrix? Surgical Matrix Thin | 2019-02-07 |
ACELL, INC. | Gentrix? Surgical Matrix Plus | 2019-02-07 |
ACELL, INC. | Gentrix? Surgical Matrix Hiatal | 2019-02-07 |
ACell, Inc. | Cytal Wound Particulate | 2018-05-11 |
ACELL, INC. | XPANSION Micro Autografting Kit | 2017-12-14 |
ACELL, INC. | ABRA Surgical Kit | 2017-11-08 |
ACELL, INC. | ABRA Adhesive Kit | 2017-11-08 |
ACELL, INC. | ABRA Abdominal Kit | 2017-11-08 |
ACell, Inc. | MicroMatrix? | 2017-10-18 |
ACELL, INC. | MicroMatrix? | 2017-10-18 |
ACell, Inc. | MicroMatrix | 2017-10-06 |
ACELL, INC. | Lancet | 2017-08-15 |
ACell, Inc. | Gentrix? Surgical Matrix Thick; Gentrix? Surgical Matrix Extend | 2017-06-09 |
ACELL, INC. | Gentrix? Surgical Matrix Thick; Gentrix? Surgical Matrix Extend | 2017-06-09 |
ACell, Inc. | Gentrix? Surgical Matrix Thick; Gentrix? Surgical Matrix Extend | 2017-06-09 |
ACELL, INC. | Gentrix? Surgical Matrix Thick; Gentrix? Surgical Matrix Extend | 2017-06-09 |
ACell, Inc. | Gentrix? Surgical Matrix Thick; Gentrix? Surgical Matrix Extend | 2017-06-09 |
ACELL, INC. | Gentrix? Surgical Matrix Thick; Gentrix? Surgical Matrix Extend | 2017-06-09 |
ACell, Inc. | Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend | 2017-06-08 |
ACell, Inc. | GentrixTM Surgical Matrix 8-Layer | 2016-12-11 |
ACell, Inc. | GentrixTM Surgical Matrix 6-Layer | 2016-12-11 |
ACell, Inc. | GentrixTM Surgical Matrix 3-Layer | 2016-12-11 |
ACell, Inc. | GentrixTM Surgical Matrix 2-Layer | 2016-12-11 |
ACELL, INC. | GentrixTM Surgical Matrix 8-Layer | 2016-12-11 |
ACELL, INC. | GentrixTM Surgical Matrix 6-Layer | 2016-12-11 |
ACELL, INC. | GentrixTM Surgical Matrix 3-Layer | 2016-12-11 |
ACELL, INC. | GentrixTM Surgical Matrix 2-Layer | 2016-12-11 |
ACell, Inc. | GentrixTM Surgical Matrix 8-Layer | 2016-12-11 |
ACell, Inc. | GentrixTM Surgical Matrix 6-Layer | 2016-12-11 |
ACell, Inc. | GentrixTM Surgical Matrix 3-Layer | 2016-12-11 |
ACell, Inc. | GentrixTM Surgical Matrix 2-Layer | 2016-12-11 |
ACELL, INC. | GentrixTM Surgical Matrix 8-Layer | 2016-12-11 |
ACELL, INC. | GentrixTM Surgical Matrix 6-Layer | 2016-12-11 |
ACELL, INC. | GentrixTM Surgical Matrix 3-Layer | 2016-12-11 |
ACELL, INC. | GentrixTM Surgical Matrix 2-Layer | 2016-12-11 |
ACELL, INC. | Suturesafe | 2016-12-11 |
ACELL, INC. | Dynastretch | 2016-12-11 |
ACELL, INC. | Dynaclose | 2016-12-11 |
ACELL, INC. | Loop Canulator / Canulator | 2016-12-11 |
ACELL, INC. | Skin Anchors | 2016-12-11 |
ACELL, INC. | Silicone Elastomer Cord | 2016-12-11 |
ACELL, INC. | Elastomeric Retainer | 2016-12-11 |
ACELL, INC. | Button Tails | 2016-12-11 |
ACELL, INC. | Button Anchors | 2016-12-11 |
ACELL, INC. | Adhesive Anchors | 2016-12-11 |
ACELL, INC. | Southmedic Surgical Retainer | 2016-12-11 |
Acell, Inc. | Gentrix Surgical Matrix | 2016-10-21 |
ACell, Inc. | MicroMatrix? | 2016-03-16 |
ACELL, INC. | MicroMatrix? | 2016-03-16 |
ACELL, INC | MicroMatrix | 2016-03-14 |
ACell, Inc. | Cytal? Wound Matrix 6-Layer | 2015-12-14 |
ACell, Inc. | Cytal? Wound Matrix 3-Layer | 2015-12-14 |
ACell, Inc. | Cytal? Wound Matrix 2-Layer | 2015-12-14 |
ACell, Inc. | Cytal? Wound Matrix 1-Layer | 2015-12-14 |
ACell, Inc. | Cytal? Burn Matrix | 2015-12-14 |
ACELL, INC. | Cytal? Wound Matrix 6-Layer | 2015-12-14 |
ACELL, INC. | Cytal? Wound Matrix 3-Layer | 2015-12-14 |
ACELL, INC. | Cytal? Wound Matrix 2-Layer | 2015-12-14 |
ACELL, INC. | Cytal? Wound Matrix 1-Layer | 2015-12-14 |
ACELL, INC. | Cytal? Burn Matrix | 2015-12-14 |
ACELL, INC | Cytal Wound Matrix | 2015-12-08 |
ACELL, INC | Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix | 2015-06-17 |
ACELL, INC | MATRISTEM WOUND MATRIX | 2011-08-29 |
ACELL, INC | ACELL MATRISTEM WOUND SHEET | 2009-10-28 |
ACELL, INC. | Gentrix Incisional Matrix | 2009-05-26 |
ACELL, INC | ACELL POWDER WOUND DRESSING | 2006-06-23 |
ACELL, INC | ACELL UBM SURGICAL MESH ML AND MLPLUS | 2004-07-07 |
ACELL, INC | ACELL UBM SURGICAL MESH | 2004-04-14 |
ACELL, INC | ACELL UBM HYDRATED WOUND DRESSING | 2002-12-30 |
ACELL, INC | ACELL UBM LYOPHILIZED WOUND DRESSING | 2002-12-19 |
| NCAGE Code | 58S76 | ACELL, INC. |
| CAGE Code | 47YT6 | ACELL INC. |
| CAGE Code | 58S76 | ACELL, INC. |
| S.A.M. Registration | 58S76 [137258252] | ACELL, INC. |
| SEC | 0001170005 | ACELL INC of DELAWARE |