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.
- CanadaDI SCAN110855
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
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2021-02 | 0 | 1.14 |
| 2021-04 | 1 | 1.14 |
| 2023-08 | 0 | 2 |
| 2023-09 | 0 | 3 |
| 2023-10 | 0 | 3 |
| 2024-05 | 0 | 3 |
| 2024-06 | 0 | 3 |
| 2025-06 | 0 | 1 |
| 2025-07 | 0 | 1 |
| 2025-09 | 0 | 2 |
| 2025-12 | 0 | 2 |
Recall history
No recalls linked.
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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