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 |
|---|---|---|---|---|
| 2019-05-23 | NAI | No action indicated | 3A Medical Products Co., Ltd. | 0 |
| 2019-05-23 | NAI | No action indicated | 3A Medical Products Co., Ltd. | 0 |
Similar devices
- 1MED Qyk Brands LLC
- AHS American Health Service Sales Corporation
- AHS American Health Service Sales Corporation
- AHS American Health Service Sales Corporation
- AHS American Health Service Sales Corporation
- AHS American Health Service Sales Corporation
- AHS American Health Service Sales Corporation
- AHS American Health Service Sales Corporation
- AHS American Health Service Sales Corporation
- AHS American Health Service Sales Corporation
- AHS American Health Service Sales Corporation
- AHS American Health Service Sales Corporation
Select up to two to place side-by-side with this device.