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 |
|---|---|---|---|---|
| 2018-08-17 | NAI | No action indicated | Bayer Medical Care, Inc. | 0 |
| 2018-08-17 | NAI | No action indicated | Bayer Medical Care, Inc. | 0 |
| 2017-01-19 | NAI | No action indicated | Bayer Medical Care, Inc. | 0 |
| 2017-01-19 | NAI | No action indicated | Bayer Medical Care, Inc. | 0 |
| 2017-01-18 | NAI | No action indicated | Bayer Medical Care, Inc. | 0 |
| 2017-01-18 | NAI | No action indicated | Bayer Medical Care, Inc. | 0 |
| 2017-01-06 | NAI | No action indicated | Bayer Medical Care, Inc. | 0 |
| 2017-01-06 | NAI | No action indicated | Bayer Medical Care, Inc. | 0 |
| 2015-04-16 | NAI | No action indicated | Bayer Medical SRL | 0 |
| 2014-03-20 | NAI | No action indicated | Bayer Medical Care Inc. | 0 |
| 2013-08-12 | NAI | No action indicated | Bayer Medical Care, Inc. | 0 |
| 2013-08-12 | NAI | No action indicated | Bayer Medical Care, Inc. | 0 |
| 2013-08-07 | NAI | No action indicated | Bayer Medical Care, Inc. | 0 |
| 2013-08-07 | NAI | No action indicated | Bayer Medical Care, Inc. | 0 |
| 2013-08-01 | NAI | No action indicated | Bayer Medical Care, Inc. | 0 |
| 2013-08-01 | NAI | No action indicated | Bayer Medical Care, Inc. | 0 |
| 2012-05-02 | NAI | No action indicated | Bayer Medical Care, Inc. | 0 |
| 2012-05-02 | NAI | No action indicated | Bayer Medical Care, Inc. | 0 |
| 2011-08-23 | NAI | No action indicated | Bayer Medical Care, Inc. | 0 |
| 2011-08-23 | NAI | No action indicated | Bayer Medical Care, Inc. | 0 |
| 2011-05-19 | WL | Warning Letter | Bayer Medical Care, Inc. | — |
| 2011-05-19 | WL | Warning Letter | Bayer Medical Care, Inc. | — |
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