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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device extractor, vacuum, fetal
Regulation Description Fetal vacuum extractor.
Product CodeHDB
Regulation Number 884.4340
Device Class 2


Premarket Reviews
ManufacturerDecision
CLINICAL INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GO MEDICAL INDUSTRIES PTY. LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOLLISTER, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDELA
  SUBSTANTIALLY EQUIVALENT 3
PRISM
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Unexpected therapeutic results 2
Device inoperable 2
Normal 2
Source, detachment from 2
Increase in suction 1
Use of Device Issue 1
Suction issue 1
Unknown (for use when the device problem is not known) 1
Device operates differently than expected 1
Total Device Problems 13

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 1 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 Cooper Surgical, Inc. II Sep-17-2008

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