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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sealant,polymerizing
Product CodeNBE
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013
4 4 2 10 6 12 3

Device Problems
Improper or incorrect procedure or method 3
Obstruction within device 1
Device displays error message 1
Improper device output 1
Blockage within device or device component 1
Migration of device or device component 1
Total Device Problems 8

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 1 0 2 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Bioscience II Jul-02-2010
2 Baxter Healthcare Services L.P. II May-16-2012
3 Neomend Inc II Sep-25-2012

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