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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device apparatus, exhaust, surgical
Regulation Description Air-handling apparatus for a surgical operating room.
Product CodeFYD
Regulation Number 878.5070
Device Class 2


Premarket Reviews
ManufacturerDecision
BEI MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
CONMED
  SUBSTANTIALLY EQUIVALENT 2
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
I.C. MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
ISOMEDIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
PALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STACKHOUSE
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
UTAH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VALLEYLAB
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 2
Electrical issue 2
Suction issue 2
Spark 1
No Known Device Problem 1
Total Device Problems 8

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 1 0 0 0 0
Class II 0 0 0 1 0 0 0 1 2 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Microtek Medical Inc II Mar-27-2015
2 Microtek Medical Inc II Jul-28-2010
3 Stryker Instruments Div. of Stryker Corporation II Sep-01-2015
4 Stryker Instruments Div. of Stryker Corporation II Apr-24-2014
5 Stryker Instruments Div. of Stryker Corporation I Aug-15-2012

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