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 Union10405 Permanent Marker; Round Pen Regular Tip (Purple)B-00787551008265
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.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-02-06 | NAI | No action indicated | Xodus Medical Inc | 0 |
| 2026-02-06 | NAI | No action indicated | Xodus Medical Inc | 0 |
| 2019-08-14 | VAI | Voluntary action indicated | Xodus Medical Inc | 7 |
| 2019-08-14 | VAI | Voluntary action indicated | Xodus Medical Inc | 7 |
| 2017-10-10 | NAI | No action indicated | Xodus Medical Inc | 0 |
| 2017-10-10 | NAI | No action indicated | Xodus Medical Inc | 0 |
| 2015-07-10 | NAI | No action indicated | Xodus Medical Inc | 0 |
| 2015-07-10 | NAI | No action indicated | Xodus Medical Inc | 0 |
| 2013-02-19 | VAI | Voluntary action indicated | Xodus Medical Inc | 2 |
| 2013-02-19 | VAI | Voluntary action indicated | Xodus Medical Inc | 2 |
| 2012-09-21 | NAI | No action indicated | Xodus Medical Inc | 0 |
| 2012-09-21 | NAI | No action indicated | Xodus Medical Inc | 0 |
| 2010-09-13 | NAI | No action indicated | Xodus Medical Inc | 0 |
| 2010-09-13 | NAI | No action indicated | Xodus Medical Inc | 0 |
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