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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
01112021-12: 1 reports for this device2022-01: 1 reports for this device2022-03: 1 reports for this device2023-05: 1 reports for this device2023-10: 1 reports for this device2023-11: 1 reports for this device2026-05: 1 reports for this device12010305101105
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-121—
2022-011—
2022-031—
2023-051—
2023-101—
2023-111—
2026-051—
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
2026-05-013014128390-2026-00011InjuryAvailableexact di
2023-11-143009532798-2023-00111InjuryAvailableexact di
2023-10-103009532798-2023-00090InjuryAvailableexact di
2023-05-233009532798-2023-00034InjuryAvailableexact di
2022-03-033009532798-2022-00026InjuryAvailableexact di
2022-01-253014128390-2022-00002InjuryAvailableexact di
2021-12-273014128390-2021-00069InjuryAvailableexact di
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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