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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 7
01112021-07: 1 reports for this device2022-01: 1 reports for this device2022-02: 1 reports for this device2023-01: 1 reports for this device2023-07: 1 reports for this device2025-07: 1 reports for this device2025-11: 1 reports for this device07010201070711
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-071—
2022-011—
2022-021—
2023-011—
2023-071—
2025-071—
2025-111—
This device (reports/month)Average device in its product code (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
2025-11-243009532798-2025-00068InjuryAvailableexact di
2025-07-183009532798-2025-00049InjuryAvailableexact di
2023-07-063009532798-2023-00055InjuryAvailableexact di
2023-01-203009532798-2023-00006InjuryAvailableexact di
2022-02-033009532798-2021-00253InjuryAvailableexact di
2022-01-123009532798-2021-00255InjuryAvailableexact di
2021-07-133009532798-2021-00097InjuryAvailableexact di
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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