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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lamp, surgical
Regulation Description Surgical lamp.
Product CodeFTD
Regulation Number 878.4580
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRICURE, INC.
  SUBSTANTIALLY EQUIVALENT 2
BURTON MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ENGINEERED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL ILLUMINATION
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
WARNER-LAMBERT CO.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device component 48
Component falling 37
Flaked 8
Break 7
Degraded 7
Device operates differently than expected 7
Use of Device Issue 6
Mechanical issue 6
Component(s), broken 5
No Known Device Problem 5
Crack 4
Other (for use when an appropriate device code cannot be identified) 3
Detachment of device or device component 3
Device maintenance issue 2
Dislodged or dislocated 2
Component missing 2
Material fragmentation 2
Handpiece break 2
Electrical issue 2
Unintended ejection 1
Fire 1
Charred 1
Component(s), worn 1
Heat 1
Melted 1
Particulates 1
Difficult to position 1
Loss of power 1
Smoking 1
Device inoperable 1
Out-of-box failure 1
Device or device fragments location unknown 1
Device displays error message 1
Fitting problem 1
Environmental control or utility issue 1
Human-Device Interface Issue 1
Temperature issue 1
Torn material 1
Device or device component damaged by another device 1
Total Device Problems 178

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 1 0 4 2 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 Berchtold Corp. II Dec-10-2010
2 Draeger Medical, Inc. II Sep-16-2009
3 MAQUET Inc. II Nov-12-2009
4 MAQUET Inc. II Apr-12-2009
5 Skytron, Div. The KMW Group, Inc II Feb-22-2007
6 Steris Corp II Nov-23-2009
7 Steris Corporation II Apr-01-2010

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