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 |
|---|---|---|---|---|
| 2018-12-03 | NAI | No action indicated | Natus Medical Incorporated | 0 |
| 2018-08-14 | VAI | Voluntary action indicated | NATUS MEDICAL INCORPORATED | 1 |
| 2018-08-14 | VAI | Voluntary action indicated | NATUS MEDICAL INCORPORATED | 1 |
| 2018-08-13 | VAI | Voluntary action indicated | Natus Medical Incorporated | 1 |
| 2017-06-27 | NAI | No action indicated | Natus Medical Incorporated | 0 |
| 2016-10-27 | VAI | Voluntary action indicated | Natus Manufacturing Limited | 0 |
| 2016-09-09 | NAI | No action indicated | Natus Medical Inc. | 0 |
| 2016-07-27 | VAI | Voluntary action indicated | Natus Medical Incorporated | 12 |
| 2016-04-29 | NAI | No action indicated | Natus Medical Incorporated | 0 |
| 2016-04-29 | NAI | No action indicated | Natus Medical Incorporated | 0 |
| 2015-04-15 | NAI | No action indicated | NATUS MEDICAL INCORPORATED | 0 |
| 2015-04-15 | NAI | No action indicated | NATUS MEDICAL INCORPORATED | 0 |
| 2015-04-14 | NAI | No action indicated | Natus Medical Inc | 0 |
| 2015-04-10 | WL | Warning Letter | Natus Medical Incorporated | — |
| 2015-03-30 | NAI | No action indicated | Natus Medical Incorporated | 0 |
| 2014-09-10 | OAI | Official action indicated | Natus Medical Incorporated | 7 |
| 2014-07-18 | NAI | No action indicated | Natus Neurology Inc | 0 |
| 2014-04-11 | VAI | Voluntary action indicated | Natus Medical Incorporated | 0 |
| 2014-04-11 | VAI | Voluntary action indicated | Natus Medical Incorporated | 0 |
| 2014-01-23 | VAI | Voluntary action indicated | Natus Manufacturing Limited | 0 |
| 2013-04-25 | NAI | No action indicated | Natus Medical Inc. | 0 |
Similar devices
- ALGO Natus Medical Denmark ApS
- 1052 OTOsuite Natus Medical Denmark ApS
- 1052 OTOsuite Natus Medical Denmark ApS
- 1066 OTOsuite Natus Medical Denmark ApS
- 1077 ALPHA DPOAE PROBE PATH medical GmbH
- 1077 Accessory Box AB07 PATH medical GmbH
- 1077 AccuScreen Natus Medical Denmark ApS
- 1077 DPOAE/TEOAE PROBE PATH medical GmbH
- 1077 EAR COUPLER CABLE PATH medical GmbH
- 1077 EARTIP 12-16 BLUE 100 PCS PATH medical GmbH
- 1077 EARTIP 12-16 BLUE 250 PCS PATH medical GmbH
- 1077 EARTIP 12-16 BLUE 50 PCS PATH medical GmbH
Select up to two to place side-by-side with this device.