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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)
2019 2020 2021 2022 2023 2024
6 15 8 6 9 3

MDR Year MDR Reports MDR Events
2019 18 18
2020 10 10
2021 15 15
2022 10 10
2023 11 11
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 47 47
Low Test Results 11 11
No Apparent Adverse Event 5 5
High Readings 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 40 40
No Known Impact Or Consequence To Patient 24 24
No Consequences Or Impact To Patient 3 3

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