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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device device, sensing, optical contour
Product CodeLDK
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
CRYOS TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
MOMENTUM HEALTH INC.
  SUBSTANTIALLY EQUIVALENT 1
NSITE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1 1
Erosion 1 1

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