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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 device, inflation, middle ear
Product CodeMJV
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
EXERCORE, LLC
  SUBSTANTIALLY EQUIVALENT 1
NINGBO ALBERT NOVOSINO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2017 1 1
2019 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 2 2
Tinnitus 2 2
Nausea 1 1
No Code Available 1 1
Dizziness 1 1
Disability 1 1
Perforation 1 1
Sinus Perforation 1 1
Vertigo 1 1
Partial Hearing Loss 1 1

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