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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Product CodeLOK
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
1 3 14 11 11 6 5 3 6 8 6 15 8 6 9 3

MDR Year MDR Reports MDR Events
2014 12 12
2015 2 2
2016 4 4
2017 11 11
2018 17 17
2019 18 18
2020 10 10
2021 15 15
2022 10 10
2023 11 11
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 77 77
Low Test Results 15 15
Adverse Event Without Identified Device or Use Problem 8 8
No Apparent Adverse Event 6 6
High Readings 3 3
Incorrect Or Inadequate Test Results 2 2
Nonstandard Device 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 57 57
No Clinical Signs, Symptoms or Conditions 39 39
No Consequences Or Impact To Patient 15 15
Test Result 1 1

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