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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device light, surgical, fiberoptic
Regulation Description Surgical lamp.
Product CodeFST
Regulation Number 878.4580
Device Class 2


Premarket Reviews
ManufacturerDecision
GULF MEDICAL FIBEROPTICS
  SUBSTANTIALLY EQUIVALENT 1
INVUITY, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL ILLUMINATION
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 1
PENTAX
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
THOMAS SURGICAL INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Burn of device or device component 2
Device operates differently than expected 2
No Known Device Problem 2
Overheating of device or device component 2
Use of Device Issue 1
Device misassembled during manufacturing or shipping 1
Break 1
Power source issue 1
Temperature issue 1
No Information 1
Device handling issue 1
Detachment of device component 1
Electrical issue 1
Fracture 1
Total Device Problems 18

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 3 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Gulf Fiberoptics, Inc. II Jul-18-2012
2 Gulf Medical Fiberoptics, Inc. II Jan-20-2012
3 Integra LifeSciences Corp. II Jan-11-2012
4 Steris Corporation II Jan-07-2015

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