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.
- United StatesDEKNATEL14026704738981
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 |
|---|---|---|---|---|
| 2017-09-20 | VAI | Voluntary action indicated | Teleflex Medical, Inc. | 1 |
| 2014-12-15 | NAI | No action indicated | Teleflex Medical Gmbh | 0 |
| 2013-01-11 | NAI | No action indicated | Teleflex Medical | 0 |
| 2012-10-24 | NAI | No action indicated | Teleflex Medical, Inc. | 0 |
| 2010-06-01 | NAI | No action indicated | Teleflex Medical | 0 |
| 2010-03-23 | VAI | Voluntary action indicated | Teleflex Medical | 1 |
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