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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device container, sharps
Regulation Description Hypodermic single lumen needle.
Product CodeMMK
Regulation Number 880.5570
Device Class 2


Premarket Reviews
ManufacturerDecision
ANCHOR PRODUCTS CO.
  SUBSTANTIALLY EQUIVALENT 1
ASP PLASTICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
BD
  SUBSTANTIALLY EQUIVALENT 1
BEMIS HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 7
BIODEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL PATHOGEN SOLUTIONS INC.
  SUBSTANTIALLY EQUIVALENT 1
INDUSTRIAL WATER SOLUTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 2
MEDPORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
SAGE PRODUCTS
  SUBSTANTIALLY EQUIVALENT 5
SHARPS COMPLIANCE, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPECIALIZED HEALTH PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
TECHEN SAFETY, INC.
  SUBSTANTIALLY EQUIVALENT 1
ULTIMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZHEJIANG GONGDONG MEDICAL PLASTIC FACTORY
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material puncture 27
Unknown (for use when the device problem is not known) 7
Other (for use when an appropriate device code cannot be identified) 5
Use of Device Issue 4
Material Protrusion 3
Shielding failure 3
Sticking 2
Device handling issue 2
No Known Device Problem 1
No Information 1
No code available 1
Break 1
Crack 1
Pierce 1
Defective component 1
Device Issue 1
Difficult to open or close 1
Total Device Problems 62

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 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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