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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 29
Mechanical issue 15
Use of Device Issue 13
Device Issue 8
Defective component 7
Unstable 7
Loose or intermittent connection 7
No Known Device Problem 7
Unintended movement 7
Device handling issue 6
Break 6
Component falling 6
Fracture 5
Detachment of device component 5
Slippage of device or device component 4
Unintended head motion 4
Melted 3
Overheating of device or device component 3
Failure to advance 3
Material integrity issue 3
No code available 3
Not Applicable 2
Positioning Issue 2
Tipover 2
Detachment of device or device component 2
Table, tilting 2
Markings unclear 2
Other (for use when an appropriate device code cannot be identified) 2
Product quality issue 2
Device remains activated 1
Material separation 1
Device maintenance issue 1
Crack 1
Disconnection 1
Fail-safe design failure 1
Circuit Failure 1
Failure to Adhere or Bond 1
Unintended arm motion 1
Bent 1
Unknown (for use when the device problem is not known) 1
Improper or incorrect procedure or method 1
Fitting problem 1
Patient-device incompatibility 1
Component missing 1
Tear, rip or hole in device packaging 1
Incorrect device or component shipped 1
Material deformation 1
No Information 1
Total Device Problems 186

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 2 0 0 0
Class II 1 0 3 1 0 3 2 0 2 0 1
Class III 0 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 OSI II Apr-19-2017
13 Mizuho Orthopedic Systems Inc II Mar-13-2012
14 Orthopedic Systems Inc II May-04-2007
15 Sterilmed Inc II Jan-13-2009

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