Lifecell Corp.
Medical device manufacturer in Branchburg, NJ.
15510(k) clearances
0PMA approvals
5recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K193539 | REVOLVE ENVI 600 Advanced Adipose SystemMUU · Traditional | 05/28/2020SE |
| K163647 | Revolve Envi 600 Advanced Adipose SystemMUU · Traditional | 08/25/2017SE |
| K162752 | ARTIA Reconstructive Tissue Matrix PerforatedFTM · Traditional | 02/24/2017SE |
| K150712 | LTM-Perforated Surgical MeshFTM · Traditional | 07/02/2015SE |
| K142326 | HP Tissue MatrixFTM · Traditional | 12/23/2014SE |
| K130817 | LTN - Laparoscopic Surgical MeshOXK · Special | 04/17/2013SE |
| K112534 | Lifecell Tissue ExpanderLCJ · Traditional | 08/10/2012SE |
| K121289 | Ltm-Labaroscopic Surgical MeshOXK · Traditional | 08/03/2012SE |
| K082176 | Ltm-Bps Surgical MeshFTM · Traditional | 11/14/2008SE |
| K082103 | LTM Wound DressingKGN · Traditional | 10/08/2008SE |
| K080353 | Ltm-T Surgical MeshFTL · Traditional | 04/03/2008SE |
| K071986 | Ltm-Rc Surgical MeshFTM · Traditional | 10/19/2007SE |
| K070560 | LRTM Surgical MeshFTM · Traditional | 06/11/2007SE |
| K061208 | Lifecell Dural Substitute MatrixGXQ · Traditional | 01/03/2007SE |
| K052735 | Allocraft DBMMBP · Traditional | 12/28/2005SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0178-2012 | LifeCell Strattice Reconstructive Tissue Matrix for Stoma Reinforcement Catalog #0606008…The use of Strattice for stoma reinforcement at the time of stoma creation is not within the product's… | 07/13/2011Terminated |
| Z-0162-2011 | IV Catheter - Optiva IV Catheter. This is found in box labeled 'Graft Jacket Xpress…Graft Jacket Xpress kits contain catheters that will expire or have already expired prior to the labeled… | 09/13/2010Terminated |
| Z-2623-2010 | Strattice Reconstructive Tissue Matrix for Stoma Reinforcement. 8 cm x 8 cm Packaged in…Mislabeled -One lot of product labeled as 8 cm x 8 cm were actually cut using a 6 cm x 6 cm template. | 07/12/2010Terminated |
| Z-1299-2008 | AlloCraft DBM with Syringe Assembly, 10 CC, LifeCell Corporation, Branchburg, NJ 08876…Improper donor screening test; diagnostic test kits were used in lieu of a donor screening test kits for… | 10/17/2007Terminated |
| Z-1298-2008 | AlloCraft DBM with Syringe Assembly, 5CC, Catalog/Reorder Number: 653005, LifeCell…Improper donor screening test; diagnostic test kits were used in lieu of a donor screening test kits for… | 10/17/2007Terminated |