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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, laryngeal (taub)
Regulation Description Laryngeal prosthesis (Taub design).
Product CodeEWL
Regulation Number 874.3730
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOVNA MEDICAL
  SUBSTANTIALLY EQUIVALENT 8
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
HELIX MEDICAL
  SUBSTANTIALLY EQUIVALENT 12
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 1
Dislodged 1
Total Device Problems 2

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

Recalls
Manufacturer Recall Class Date Posted
1 Helix Medical LLC III Sep-07-2012

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