Regulatory

Every AR/VR device the FDA has authorized.

120 devices from 70 companies, copied from the FDA's own list and checked for changes every day. Each row links to its FDA database record.

This is the regulator's list, shown as published. FDA authorization means a device may be marketed in the US for its stated use; it is not evidence of clinical effectiveness and not an AVRMD endorsement. Source: FDA, Augmented Reality and Virtual Reality Medical Devices (FDA page updated 2026-09-04).

17 devices
  1. 2025-10-21NeuroAlign softwareMedivis, Inc.NeurologyK231897
  2. 2025-10-03xvision Spine systemAugmedics, Ltd.NeurologyK251639
  3. 2025-09-29SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.AVRMD record: Surgical Theater XRNeurologyK252054
  4. 2025-09-10OptiVu™ ShoulderMR Surgical Solutions, LLCNeurologyK252530
  5. 2025-09-04NextAR(TM) Shoulder PlatformMedacta International S.A.NeurologyK251737
  6. 2025-08-25NeuroEars-Anna™NeuroEars Inc.NeurologyK243709
  7. 2025-08-13RelieVRx (Pico G3)AppliedVRAVRMD record: RelieVRxNeurologyK251519
  8. 2025-08-08OptiVu™ ShoulderMR Surgical Solutions, LLCNeurologyK252170
  9. 2025-07-31NextAR(TM) SpineMedacta International S.A.NeurologyK250477
  10. 2025-07-09OptiVu™ ShoulderMR Surgical Solutions, LLCNeurologyK250108
  11. 2025-07-08ExcelsiusXR™Globus Medical, Inc.NeurologyK241525
  12. 2025-06-20Navient Image Guided Navigation System (ENT) (955-NC-NC)ClaronavNeurologyK243053
  13. 2025-05-16Mixed Reality Spine NavigationBrainlab AGNeurologyK242569
  14. 2025-03-21ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty LimitedNeurologyK243980
  15. 2025-03-20Knee+Pixee MedicalNeurologyK243975
  16. 2025-03-13xvision Spine systemAugmedics Ltd.NeurologyK250255
  17. 2025-01-13ARVIS® ShoulderKico Knee Innovation Company Pty LtdNeurologyK243950