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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 vapocoolant device
Product CodeMLY
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
623 MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
CRYOSCIENCE NORTH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
GEBAUER COMPANY
  SUBSTANTIALLY EQUIVALENT 2
ITW CONTAMINATION CONTROL ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
NUANCE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
VAPOCOOLSHOT, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Fire 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Superficial (First Degree) Burn 2 2

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