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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 monitor, pressure, intracompartmental
Product CodeLXC
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
COMPREMIUM AG
  SUBSTANTIALLY EQUIVALENT 1
MY01 INC.
  SUBSTANTIALLY EQUIVALENT 2
MY01, INC.
  SUBSTANTIALLY EQUIVALENT 2
TWIN STAR MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 2 2
2015 1 1
2016 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 2 2
Device Operates Differently Than Expected 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Temperature Problem 1 1
Unable to Obtain Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
No Consequences Or Impact To Patient 1 1
Loss of consciousness 1 1
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MY01, INC. II Aug-27-2021
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