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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.

9 linked reportsInjury 9
12232021-04: 1 reports for this device2021-07: 1 reports for this device2021-09: 3 reports for this device2023-03: 1 reports for this device2023-07: 2 reports for this device2025-05: 1 reports for this device040709030705
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-041—
2021-071—
2021-093—
2023-031—
2023-072—
2025-051—
This device (reports/month)Average device in its product code (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-05-123009532798-2025-00033InjuryAvailableexact di
2023-07-283009532798-2023-00073InjuryAvailableexact di
2023-07-063009532798-2023-00053InjuryAvailableexact di
2023-03-023009532798-2023-00008InjuryAvailableexact di
2021-09-013009532798-2021-00131InjuryAvailableexact di
2021-09-013009532798-2021-00127InjuryAvailableexact di
2021-09-013009532798-2021-00126InjuryAvailableexact di
2021-07-133009532798-2021-00100InjuryAvailableexact di
2021-04-303009532798-2021-00047InjuryAvailableexact di
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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