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.
- European UnionHook ScissorB-04250337102823
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) |
|---|---|---|
| 2020-06 | 0 | 4 |
| 2023-03 | 0 | 3 |
| 2023-04 | 0 | 3 |
| 2023-07 | 0 | 3 |
| 2024-11 | 1 | — |
Recall history
No recalls linked.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2018-07-04 | VAI | Voluntary action indicated | Joimax GmbH | 0 |
| 2018-07-04 | VAI | Voluntary action indicated | Joimax GmbH | 0 |
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