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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 8 of 8 Results
510(K) Number: K123878
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Product Description
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Recall
Class
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FDA Recall
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PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management Syste... 2 03/05/2014 KCI USA, INC.
PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Mana... 2 03/05/2014 KCI USA, INC.
PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System is inten... 2 03/05/2014 KCI USA, INC.
PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision Management Sys... 2 03/05/2014 KCI USA, INC.
PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena Incision... 2 03/05/2014 KCI USA, INC.
PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product Usage: The Prev... 2 03/05/2014 KCI USA, INC.
PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management Sys... 2 03/05/2014 KCI USA, INC.
PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incision Ma... 2 03/05/2014 KCI USA, INC.
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