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
- 510(k)K112983Substantially equivalent (SESE) · 2011-12-12clearance family
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2017-06-15 | NAI | No action indicated | Tecres S.p.A. | 1 |
| 2015-08-14 | WL | Warning Letter | Tecres S.p.A. | — |
| 2015-02-05 | OAI | Official action indicated | Tecres S.p.A. | 4 |
| 2012-01-26 | VAI | Voluntary action indicated | Tecres S.p.A. | 3 |
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