Augmedics Ltd.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1761-2025Class IIAugmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) sApril 14, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K251639xvision Spine systemOctober 3, 2025
K250255xvision Spine systemMarch 13, 2025
K241481xvision Spine SystemOctober 16, 2024
K220905xvision Spine SystemNovember 17, 2022
K211188xvision Spine system (XVS)July 19, 2021
K190929xvision Spine system (XVS)December 20, 2019