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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 hemostatic wound dressing without thrombin or other biologics
Definition To temporarily control bleeding and cover external wounds.
Product CodeQSY
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
ADVAMEDICA INC.
  SUBSTANTIALLY EQUIVALENT 1
GEL-E, INC.
  SUBSTANTIALLY EQUIVALENT 2
HANGZHOU ZEO-INNOV LIFE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INCORE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LES LABORATOIRES BROTHIER S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRADE PRODUCT LTD
  SUBSTANTIALLY EQUIVALENT 1
MEDTRADE PRODUCTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOLAPLUS BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
STARCH MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Improper Chemical Reaction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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