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FDA-listed AR/VR medical devices

Devices the FDA identifies as using augmented or virtual reality, with the regulators each one is registered with.

95 devices · when each source was last refreshed

Registers: US (FDA) · UK (MHRA) · CA (Health Canada) · AU (TGA) · EU (EUDAMED)

Device
Affirm 800

Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)

Registered with
  • US (FDA)
ARAI Surgical Navigation System

Surgalign Spine Technologies

Registered with
  • US (FDA)
ARTICOR planner

Artiness S.R.L

Registered with
  • US (FDA)
ARVIS® Shoulder

Kico Knee Innovation Company Pty Limited

Registered with
  • US (FDA)
ARVIS Surgical Navigation System

Kico Knee Innovation Company Pty Limited

Registered with
  • US (FDA)
  • AU (TGA)
ARVIS Surgical Navigation System

Insight Medical Systems, Inc.

Registered with
  • US (FDA)
Augmented Reality Application

Sira Medical, Inc.

Registered with
  • US (FDA)
Avatar Medical Software V1

Avatar Medical

Registered with
  • US (FDA)
Avatar Medical Vision

Avatar Medical

Registered with
  • US (FDA)
  • EU (EUDAMED)
Blueprint Mixed Reality system

Tornier, Inc

Registered with
  • US (FDA)
  • AU (TGA)
Caduceus S

Taiwan Main Orthopaedic Biotechnology Co., Ltd.

Registered with
  • US (FDA)
CarnaLife Holo

Medapp S.A.

Registered with
  • US (FDA)
  • EU (EUDAMED)
Ceevra Reveal 2.0

Ceevra, Inc.

Registered with
  • US (FDA)
Ceevra Reveal 3

Ceevra, Inc.

Registered with
  • US (FDA)
Ceevra Reveal 3+

Ceevra, Inc.

Registered with
  • US (FDA)
Clarity Reveal

Ceevra, Inc.

Registered with
  • US (FDA)
Clarus Viewer

Clarus Viewer Corporation

Registered with
  • US (FDA)
Clear Guide SCENERGY

Clear Guide Medical

Registered with
  • US (FDA)
  • Canada (Health Canada)
CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)

Sentiar, Inc.

Registered with
  • US (FDA)
Cube Navigator

Medical Templates AG

Registered with
  • US (FDA)
Cyware 4H and Cysart 4H

Abys Medical

Registered with
  • US (FDA)
D2P

3D Systems, Inc.

Registered with
  • US (FDA)
Digital Prism Correction Feature (DPCF)

Apple, Inc.

Registered with
  • US (FDA)
EaseVRx

Appliedvr, Inc.

Registered with
  • US (FDA)
ECHO TRUE 3D VIEWER

ECHOPIXEL, INC.

Registered with
  • US (FDA)
Elements Viewer

Brainlab SE

Registered with
  • US (FDA)
  • EU (EUDAMED)
ExcelsiusXR™

Globus Medical, Inc.

Registered with
  • US (FDA)
EYE-SYNC

Syncthink, Inc.

Registered with
  • US (FDA)
HipXpert 3D Display and Anchoring Application

Surgical Planning Associates

Registered with
  • US (FDA)
HipXpert and HipInsight System

Surgical Planning Associates

Registered with
  • US (FDA)
HOLO Portal™ Surgical Guidance System

Surgalign Spine Technologies

Registered with
  • US (FDA)
HOLOSCOPE-i

Real View Imaging Ltd.

Registered with
  • US (FDA)
  • EU (EUDAMED)
Ikshana

Immersivetouch

Registered with
  • US (FDA)
ImmersiveTouch

Immersivetouch

Registered with
  • US (FDA)
IntraOp VSP Software Device

Xironetic, LLC

Registered with
  • US (FDA)
inVisionOS

PRECISIONOS TECHNOLOGY INC.

Registered with
  • US (FDA)
  • Canada (Health Canada)
I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph

Neurolign USA, LLC

Registered with
  • US (FDA)
IRIS 1.0 System

Intuitive Surgical, Inc.

Registered with
  • US (FDA)
Knee+

Pixee Medical

Registered with
  • US (FDA)
  • AU (TGA)
LAIA XR

Augmented Reality Software S.L.

Registered with
  • US (FDA)
  • EU (EUDAMED)
LumiNE US; Lumi

Augmedit B.V.

Registered with
  • US (FDA)
Luminopia

Luminopia, Inc.

Registered with
  • US (FDA)
Luminopia One

Luminopia, Inc.

Registered with
  • US (FDA)
LUMYS (V1)

Intradys

Registered with
  • US (FDA)
MindMotionPRO

NeuroXtherapeutics SA

Registered with
  • US (FDA)
Mixed Reality Spine Navigation

Brainlab SE

Registered with
  • US (FDA)
  • UK (MHRA)
Navient Image Guided Navigation System (ENT) (955-NC-NC)

Claronav, Inc.

Registered with
  • US (FDA)
Neo ADVISE software

Comerge AG

Registered with
  • US (FDA)
NeuroAlign software

Medivis, Inc.

Registered with
  • US (FDA)
NeuroEars-Anna™

Neuroears, Inc.

Registered with
  • US (FDA)