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 |
|---|---|---|---|---|
| 2025-02-19 | NAI | No action indicated | KA Medical LLC | 0 |
| 2024-11-22 | NAI | No action indicated | Merit Medical Systems, Inc. | 0 |
| 2024-11-22 | NAI | No action indicated | Merit Medical Systems, Inc. | 0 |
| 2023-10-06 | NAI | No action indicated | Merit Medical Systems, Inc. | 0 |
| 2023-10-06 | NAI | No action indicated | Merit Medical Systems, Inc. | 0 |
| 2021-12-10 | NAI | No action indicated | Merit Medical Systems, Inc. | 0 |
| 2021-12-10 | NAI | No action indicated | Merit Medical Systems, Inc. | 0 |
| 2020-03-17 | NAI | No action indicated | KA Medical LLC | 0 |
| 2017-12-07 | VAI | Voluntary action indicated | Merit Medical Systems, Inc. | 1 |
| 2017-12-07 | VAI | Voluntary action indicated | Merit Medical Systems, Inc. | 1 |
| 2017-03-15 | NAI | No action indicated | Merit Medical Systems, Inc. | 0 |
| 2017-03-15 | NAI | No action indicated | Merit Medical Systems, Inc. | 0 |
| 2016-09-27 | VAI | Voluntary action indicated | Merit Medical Systems, Inc. | 5 |
| 2016-09-27 | VAI | Voluntary action indicated | Merit Medical Systems, Inc. | 5 |
| 2016-09-09 | VAI | Voluntary action indicated | Cianna Medical, Inc. | 1 |
| 2016-06-23 | NAI | No action indicated | Merit Medical Systems, Inc. | 0 |
| 2016-06-23 | NAI | No action indicated | Merit Medical Systems, Inc. | 0 |
| 2016-06-16 | VAI | Voluntary action indicated | BioSphere Medical S.A. | 8 |
| 2016-03-22 | NAI | No action indicated | Merit Medical Systems, Inc. | 0 |
| 2016-03-22 | NAI | No action indicated | Merit Medical Systems, Inc. | 0 |
| 2012-01-30 | WL | Warning Letter | Merit Medical Ireland Ltd. | — |
Similar devices
- Anterior Cervical Interbody Fusion Device PRECISION SPINE, INC.
- 0 Deg 4mm AC Arthroscope Poc
- 1.2mm InnerVue II Scope Kit BIOVISION TECHNOLOGIES, LLC
- 1.9mm Arthroscope, 30°, Autoclavable Nexus Cmf, L.L.C.
- 10K Conmed Corporation
- 10K Conmed Corporation
- 10K Conmed Corporation
- 10K Conmed Corporation
- 10K/24K Conmed Corporation
- 10K/24K Conmed Corporation
- 10K/24K Conmed Corporation
- 10K/24K Conmed Corporation
Select up to two to place side-by-side with this device.