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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 light, surgical, accessories
Regulation Description Surgical lamp.
Product CodeFTA
Regulation Number 878.4580
Device Class 2


Premarket Reviews
ManufacturerDecision
KEY SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Component Falling 4
Device Dislodged or Dislocated 4
Material Integrity Problem 3
Mechanical Problem 2
Defective Device 1
Crack 1
Manufacturing, Packaging or Shipping Problem 1
Unintended Movement 1
Material Separation 1
Total Device Problems 18

Recalls
Manufacturer Recall Class Date Posted
1 Ecolab, Inc. II Feb-05-2018

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