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 UnionB-05055788708636B-05055788708636
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 |
|---|---|---|---|---|
| 2024-05-09 | VAI | Voluntary action indicated | FLEXICARE LANKA (PVT) LTD | 3 |
| 2024-03-21 | VAI | Voluntary action indicated | Flexicare Medical (Dongguan) Ltd. | 3 |
| 2016-10-13 | VAI | Voluntary action indicated | CLEMENT CLARKE INTL., LTD. | 5 |
| 2013-01-24 | NAI | No action indicated | Flexicare Medical (Dongguan) Ltd. | 0 |
| 2010-08-26 | OAI | Official action indicated | Flexicare Medical (Dongguan) Ltd. | 10 |
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