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
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 |
|---|---|---|---|---|
| 2024-06-03 | VAI | Voluntary action indicated | TriMed Inc. | 2 |
| 2024-06-03 | VAI | Voluntary action indicated | TriMed Inc. | 2 |
| 2019-08-14 | NAI | No action indicated | TriMed Inc. | 0 |
| 2019-08-14 | NAI | No action indicated | TriMed Inc. | 0 |
| 2017-11-17 | VAI | Voluntary action indicated | TriMed Inc. | 6 |
| 2017-11-17 | VAI | Voluntary action indicated | TriMed Inc. | 6 |
| 2017-01-12 | VAI | Voluntary action indicated | TriMed Inc. | 11 |
| 2017-01-12 | VAI | Voluntary action indicated | TriMed Inc. | 11 |
| 2016-06-30 | WL | Warning Letter | TriMed Inc. | — |
| 2016-06-30 | WL | Warning Letter | TriMed Inc. | — |
| 2016-03-18 | OAI | Official action indicated | TriMed Inc. | 13 |
| 2016-03-18 | OAI | Official action indicated | TriMed Inc. | 13 |
| 2012-01-25 | VAI | Voluntary action indicated | TriMed Inc. | 5 |
| 2012-01-25 | VAI | Voluntary action indicated | TriMed Inc. | 5 |
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