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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device illuminator, fiberoptic, surgical field
Regulation Description Surgical lamp.
Product CodeHBI
Regulation Number 878.4580
Device Class 2


Premarket Reviews
ManufacturerDecision
ISOLUX LLC
  SUBSTANTIALLY EQUIVALENT 1
KATALYST SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 3
Sparking 2
Fire 2
Break 2
Melted 2
Delivered as Unsterile Product 1
Smoking 1
Electrical Shorting 1
Overheating of Device 1
Unclear Information 1
Detachment of Device or Device Component 1
Total Device Problems 17


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