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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.

1 linked reportInjury 1
12342020-06: 0 reports for this device; peer average 4/device2023-03: 0 reports for this device; peer average 3/device2023-04: 0 reports for this device; peer average 3/device2023-07: 0 reports for this device; peer average 3/device2024-11: 1 reports for this device0603040711
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-0604
2023-0303
2023-0403
2023-0703
2024-111
This device (reports/month)Average device in HRR (reports/device/month)
Recall history

No recalls linked.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2018-07-04VAIVoluntary action indicatedJoimax GmbH0
2018-07-04VAIVoluntary action indicatedJoimax GmbH0
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