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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
11222021-03: 1 reports for this device2021-11: 1 reports for this device2021-12: 1 reports for this device2022-09: 2 reports for this device2023-11: 1 reports for this device2025-08: 1 reports for this device031112091108
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-031—
2021-111—
2021-121—
2022-092—
2023-111—
2025-081—
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
2025-08-053009532798-2025-00053InjuryAvailableexact di
2023-11-073014128390-2023-00040InjuryAvailableexact di
2022-09-203014128390-2022-00023InjuryAvailableexact di
2022-09-093009532798-2022-00128InjuryAvailableexact di
2021-12-033009532798-2021-00184InjuryAvailableexact di
2021-11-253009532798-2021-00185InjuryAvailableexact di
2021-03-193009532798-2021-00028InjuryAvailableexact di
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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