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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device operating room accessories table tray
Regulation Description Manual operating table and accessories and manual operating chair and accessories.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeFWZ
Regulation Number 878.4950
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ALLEN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INAMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 8
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 20
Mechanical issue 15
Use of Device Issue 13
Device Issue 8
Loose or intermittent connection 7
No Known Device Problem 7
Device handling issue 6
Component falling 6
Defective component 6
Detachment of device component 5
Unintended movement 5
Break 4
Fracture 4
Unintended head motion 3
Melted 3
Overheating of device or device component 3
Other (for use when an appropriate device code cannot be identified) 2
Table, tilting 2
Unstable 2
Failure to advance 2
Tipover 2
Markings unclear 2
Detachment of device or device component 2
Not Applicable 2
No code available 1
Positioning Issue 1
Material deformation 1
Material integrity issue 1
Patient-device incompatibility 1
Improper or incorrect procedure or method 1
Fitting problem 1
Unknown (for use when the device problem is not known) 1
Component missing 1
Device remains activated 1
Slippage of device or device component 1
Device maintenance issue 1
Circuit Failure 1
Bent 1
Crack 1
Disconnection 1
Fail-safe design failure 1
Total Device Problems 148

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 2 0 0
Class II 1 0 3 1 0 3 2 0 2 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Customed, Inc I Dec-16-2014
2 Customed, Inc I Aug-29-2014
3 Integra LifeSciences Corp. II Feb-21-2013
4 Integra LifeSciences Corporation II Feb-10-2015
5 Integra LifeSciences Corporation II Dec-19-2012
6 Integra LifeSciences Corporation II Sep-09-2010
7 Integra Limited II Sep-26-2012
8 MAQUET Inc. II Jan-15-2009
9 Maquet Cardiovascular Us Sales, Llc II Nov-09-2015
10 Maquet Inc. II Jan-03-2013
11 Maquet Inc. II Dec-02-2009
12 Mizuho Orthopedic Systems Inc II Mar-13-2012
13 Orthopedic Systems Inc II May-04-2007
14 Sterilmed Inc II Jan-13-2009

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