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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 cord, retraction
Product CodeMVL
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
BELPORT COMPANY, INC., GINGI-PAK
  SUBSTANTIALLY EQUIVALENT 2
CENTRIX INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
INTER-MED / VISTA DENTAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 3 3
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 2 2
Caustic/Chemical Burns 2 2
Hypersensitivity/Allergic reaction 1 1
Intraoperative Pain 1 1
Ulcer 1 1

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