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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lavage, jet
Regulation Description Jet lavage.
Product CodeFQH
Regulation Number 880.5475
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ERBE ELEKTROMEDIZIN GMBH
  SUBSTANTIALLY EQUIVALENT 3
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
HYDROCISION
  SUBSTANTIALLY EQUIVALENT 3
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 4
Detachment of device component 1
Device, or device fragments remain in patient 1
Total Device Problems 6

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

Recalls
Manufacturer Recall Class Date Posted
1 Coloplast Corp II Apr-03-2008
2 Stryker Instruments Division of Stryker Corporation II Jan-25-2011
3 Zimmer Inc. II Jul-23-2009
4 Zimmer Orthopaedic Surgical Products II Mar-06-2008

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