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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 set, perfusion, kidney, disposable
Product CodeKDL
Regulation Number 876.5880
Device Class 2


Premarket Reviews
ManufacturerDecision
DR. FRANZ KOHLER CHEMIE GMBH
  SUBSTANTIALLY EQUIVALENT 1
INSTITUT GEORGES LOPEZ
  SUBSTANTIALLY EQUIVALENT 2
S.A.L.F. SPA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2021 2 2

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 2 2
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Dr Franz Koehler Chemie Gmbh II Sep-26-2024
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