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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device table and attachments, operating-room
Regulation Description Manual operating table and accessories and manual operating chair and accessories.
Product CodeBWN
Regulation Number 878.4950
Device Class 1


Premarket Reviews
ManufacturerDecision
SCHOLTEN SURGICAL INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
T. KOROS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Improper or incorrect procedure or method 2
Unknown (for use when the device problem is not known) 1
Break 1
Detachment of device component 1
Component falling 1
Loose or intermittent connection 1
Mechanical issue 1
Total Device Problems 8

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Merit Medical Systems, Inc. II Jan-30-2014

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