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 |
|---|---|---|---|---|
| 2016-09-22 | NAI | No action indicated | GRI Medical & Electronic Technology Co., Ltd. | 0 |
| 2014-08-14 | NAI | No action indicated | GRI Medical & Electronic Technology Co., Ltd. | 0 |
| 2013-05-01 | WL | Warning Letter | GRI Medical & Electronic Technology Co., Ltd. | — |
| 2012-12-20 | OAI | Official action indicated | GRI Medical & Electronic Technology Co., Ltd. | 8 |
Similar devices
- 10651 Suture Holder XODUS MEDICAL, INC.
- 10670 Safety Stop w/Plastic Box Temp. Sharps Holder XODUS MEDICAL, INC.
- 10810 Blue Safety Foam Block XODUS MEDICAL, INC.
- 123P0102 - 70931 Needle Counter-Double Blank Magnets w/Blade Remover - PL XODUS MEDICAL, INC.
- 20cm Flexible Probe with Eye XIROS LTD
- 70110 - Single Magnet 10-20 Count XODUS MEDICAL, INC.
- 70119 1/2 Mag 1/2 Adhesive 10 Count XODUS MEDICAL, INC.
- 70120 - Double Magnet 20-40 Count XODUS MEDICAL, INC.
- 70130 Needle Counter Double Magnet 30-60 Count XODUS MEDICAL, INC.
- 70131 Needle Counter Single Magnet 15-30 Count XODUS MEDICAL, INC.
- 70160 Needle Counter Double Magnet 60-120 Count XODUS MEDICAL, INC.
- 70161 Needle Counter Single Magnet 30 Count XODUS MEDICAL, INC.
Select up to two to place side-by-side with this device.