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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device light, surgical, accessories
Regulation Description Surgical lamp.
Product CodeFTA
Regulation Number 878.4580
Device Class 2


Premarket Reviews
ManufacturerDecision
ASPEN SURGICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BURTON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
IMAGE STREAM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 3
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
WELCON, INC.
  SUBSTANTIALLY EQUIVALENT 1
XODUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Component falling 1
Material separation 1
Dislodged or dislocated 1
Total Device Problems 3

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 1 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Sunnex Inc. II Jul-24-2007

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