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).

8 devices
  1. 2022-12-16Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.NeurologyK220554
  2. 2022-11-17xvision Spine SystemAugmedics Ltd.NeurologyK220905
  3. 2022-09-29SpineAR SNAPSurgical Theater, Inc.AVRMD record: Surgical Theater XRNeurologyK213034
  4. 2022-09-01Knee+Pixee MedicalNeurologyK220104
  5. 2022-07-12Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation UnitStryker CorporationNeurologyK221098
  6. 2022-05-27VisARNovarad CorporationNeurologyK220146
  7. 2022-03-10NextAR™ TKA Platform My Knee PPSMedacta International S.A.NeurologyK213751
  8. 2022-01-14ARAI Surgical Navigation SystemSurgalign Spine TechnologiesNeurologyK211254