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Regulatory presence across jurisdictions

The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.

Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

7 linked reportsInjury 6Malfunction 1
12342019-01: 0 reports for this device; peer average 2.1/device2019-02: 0 reports for this device; peer average 2.32/device2019-03: 0 reports for this device; peer average 1.9/device2019-04: 0 reports for this device; peer average 2.37/device2019-05: 0 reports for this device; peer average 2.59/device2019-06: 0 reports for this device; peer average 1.9/device2019-07: 0 reports for this device; peer average 2.22/device2019-08: 0 reports for this device; peer average 2.61/device2019-09: 0 reports for this device; peer average 1.98/device2019-10: 0 reports for this device; peer average 2.02/device2019-11: 0 reports for this device; peer average 1.86/device2019-12: 0 reports for this device; peer average 1.81/device2020-01: 0 reports for this device; peer average 2.03/device2020-02: 0 reports for this device; peer average 1.99/device2020-03: 0 reports for this device; peer average 2.77/device2020-04: 0 reports for this device; peer average 1.94/device2020-05: 0 reports for this device; peer average 1.92/device2020-06: 0 reports for this device; peer average 2.12/device2020-07: 0 reports for this device; peer average 2.78/device2020-08: 0 reports for this device; peer average 1.9/device2020-09: 0 reports for this device; peer average 2.01/device2020-10: 0 reports for this device; peer average 2.32/device2020-11: 0 reports for this device; peer average 1.97/device2020-12: 0 reports for this device; peer average 1.94/device2021-01: 0 reports for this device; peer average 2.64/device2021-02: 0 reports for this device; peer average 2.25/device2021-03: 0 reports for this device; peer average 2.39/device2021-04: 0 reports for this device; peer average 2.35/device2021-05: 2 reports for this device; peer average 2.25/device2021-06: 2 reports for this device; peer average 2.32/device2021-07: 0 reports for this device; peer average 2.38/device2021-08: 0 reports for this device; peer average 2.45/device2021-09: 0 reports for this device; peer average 2.35/device2021-10: 0 reports for this device; peer average 2.85/device2021-11: 0 reports for this device; peer average 2.36/device2021-12: 0 reports for this device; peer average 3.62/device2022-01: 0 reports for this device; peer average 3.42/device2022-02: 0 reports for this device; peer average 2.83/device2022-03: 0 reports for this device; peer average 3.44/device2022-04: 0 reports for this device; peer average 3.11/device2022-05: 0 reports for this device; peer average 2.47/device2022-06: 0 reports for this device; peer average 2.58/device2022-07: 0 reports for this device; peer average 2.41/device2022-08: 0 reports for this device; peer average 2.61/device2022-09: 0 reports for this device; peer average 2.37/device2022-10: 0 reports for this device; peer average 2.45/device2022-11: 0 reports for this device; peer average 2.38/device2022-12: 0 reports for this device; peer average 2.59/device2023-01: 0 reports for this device; peer average 2.04/device2023-02: 0 reports for this device; peer average 2.27/device2023-03: 0 reports for this device; peer average 2.22/device2023-04: 0 reports for this device; peer average 2.56/device2023-05: 0 reports for this device; peer average 2.29/device2023-06: 0 reports for this device; peer average 2.39/device2023-07: 0 reports for this device; peer average 2.16/device2023-08: 0 reports for this device; peer average 1.92/device2023-09: 0 reports for this device; peer average 1.71/device2023-10: 0 reports for this device; peer average 1.74/device2023-11: 0 reports for this device; peer average 1.84/device2023-12: 0 reports for this device; peer average 1.52/device2024-01: 0 reports for this device; peer average 1.74/device2024-02: 0 reports for this device; peer average 2.03/device2024-03: 1 reports for this device; peer average 1.8/device2024-04: 0 reports for this device; peer average 1.99/device2024-05: 1 reports for this device; peer average 1.73/device2024-06: 0 reports for this device; peer average 1.88/device2024-07: 1 reports for this device; peer average 1.69/device2024-08: 0 reports for this device; peer average 1.77/device2024-09: 0 reports for this device; peer average 1.77/device2024-10: 0 reports for this device; peer average 1.9/device2024-11: 0 reports for this device; peer average 1.72/device2024-12: 0 reports for this device; peer average 1.71/device2025-01: 0 reports for this device; peer average 1.77/device2025-02: 0 reports for this device; peer average 1.77/device2025-03: 0 reports for this device; peer average 2.04/device2025-04: 0 reports for this device; peer average 1.87/device2025-05: 0 reports for this device; peer average 1.94/device2025-06: 0 reports for this device; peer average 2.13/device2025-07: 0 reports for this device; peer average 1.89/device2025-08: 0 reports for this device; peer average 1.73/device2025-09: 0 reports for this device; peer average 1.54/device2025-10: 0 reports for this device; peer average 1.77/device2025-11: 0 reports for this device; peer average 1.78/device2025-12: 0 reports for this device; peer average 2.29/device2026-01: 0 reports for this device; peer average 2.02/device2026-02: 0 reports for this device; peer average 1.93/device2026-03: 0 reports for this device; peer average 1.88/device2026-04: 0 reports for this device; peer average 1.78/device2026-05: 0 reports for this device; peer average 1.86/device2026-06: 0 reports for this device; peer average 1.95/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.1
2019-0202.32
2019-0301.9
2019-0402.37
2019-0502.59
2019-0601.9
2019-0702.22
2019-0802.61
2019-0901.98
2019-1002.02
2019-1101.86
2019-1201.81
2020-0102.03
2020-0201.99
2020-0302.77
2020-0401.94
2020-0501.92
2020-0602.12
2020-0702.78
2020-0801.9
2020-0902.01
2020-1002.32
2020-1101.97
2020-1201.94
2021-0102.64
2021-0202.25
2021-0302.39
2021-0402.35
2021-0522.25
2021-0622.32
2021-0702.38
2021-0802.45
2021-0902.35
2021-1002.85
2021-1102.36
2021-1203.62
2022-0103.42
2022-0202.83
2022-0303.44
2022-0403.11
2022-0502.47
2022-0602.58
2022-0702.41
2022-0802.61
2022-0902.37
2022-1002.45
2022-1102.38
2022-1202.59
2023-0102.04
2023-0202.27
2023-0302.22
2023-0402.56
2023-0502.29
2023-0602.39
2023-0702.16
2023-0801.92
2023-0901.71
2023-1001.74
2023-1101.84
2023-1201.52
2024-0101.74
2024-0202.03
2024-0311.8
2024-0401.99
2024-0511.73
2024-0601.88
2024-0711.69
2024-0801.77
2024-0901.77
2024-1001.9
2024-1101.72
2024-1201.71
2025-0101.77
2025-0201.77
2025-0302.04
2025-0401.87
2025-0501.94
2025-0602.13
2025-0701.89
2025-0801.73
2025-0901.54
2025-1001.77
2025-1101.78
2025-1202.29
2026-0102.02
2026-0201.93
2026-0301.88
2026-0401.78
2026-0501.86
2026-0601.95
This device (reports/month)Average device in PHX (reports/device/month)
Failure-mode summaryAI-generated

7 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2024-07-163014128390-2024-00038InjuryAvailableexact di
2024-05-153014128390-2024-00030InjuryAvailableexact di
2024-03-153014128390-2024-00016MalfunctionAvailableexact di
2021-06-043009532798-2021-00086InjuryAvailablecatalog number
2021-06-033014128390-2021-00033InjuryAvailablecatalog number
2021-05-283009532798-2021-00077InjuryAvailablecatalog number
2021-05-033014128390-2021-00025InjuryAvailablecatalog number
Regulatory clearances
  • 510(k)K192206Substantially equivalent (SESE) · 2019-10-08clearance family

Predicate lineage

K192206

Cited as predicate by: K193394

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

None in the loaded window.

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