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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stand, infusion
Regulation Description Infusion stand.
Product CodeFOX
Regulation Number 880.6990
Device Class 1


Premarket Reviews
ManufacturerDecision
ALLEN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPACT INSTRUMENTATION, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRYOR PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
SCHOLTEN SURGICAL INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Measurements, inaccurate 1
Unknown (for use when the device problem is not known) 1
Installation-related problem 1
Protective measure issue 1
Total Device Problems 4

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

Recalls
Manufacturer Recall Class Date Posted
1 EKOS Corporation II Sep-27-2016
2 Stryker Medical Division of Stryker Corporation II Nov-30-2015

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