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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.

2 linked reportsMalfunction 2
11222019-04: 0 reports for this device; peer average 1/device2023-03: 2 reports for this device; peer average 1.5/device0403
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0401
2023-0321.5
This device (reports/month)Average device in IZO (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2023-03-219617251-2023-00001MalfunctionAvailableexact di

Showing the most recent 1 of 2 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2025-01-24OAIOfficial action indicatedSEDECAL SA4
2013-06-28VAIVoluntary action indicatedSEDECAL SA2
2010-01-15NAINo action indicatedSEDECAL SA0
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