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
NextAR Hip Platform

Medacta International S.A.

Registered with
  • US (FDA)
NextAR RSA Platform

Medacta International S.A.

Registered with
  • US (FDA)
NextAR™ Spine Platform

Medacta International S.A.

Registered with
  • US (FDA)
  • AU (TGA)
NextAR TKA Platform

Medacta International S.A.

Registered with
  • US (FDA)
  • AU (TGA)
NextAR TKA Platform

Medacta Inernational SA

Registered with
  • US (FDA)
NextAR™ TKA Platform My Knee PPS

Medacta International S.A.

Registered with
  • US (FDA)
NextAR(TM) Shoulder Platform

Medacta International S.A.

Registered with
  • US (FDA)
NextAR(TM) Spine

Medacta International S.A.

Registered with
  • US (FDA)
NextAR™ TSA Platform

Medacta International S.A.

Registered with
  • US (FDA)
OnPoint Augmented Reality Spine System

Onpoint Surgical, Inc.

Registered with
  • US (FDA)
OPENSIGHT

Novarad Corp.

Registered with
  • US (FDA)
  • EU (EUDAMED)
OptiVu ROSA MxR

Orthosoft Inc (D/B/A Zimmer Cas)

Registered with
  • US (FDA)
OptiVu™ Shoulder

Mr Surgical Solutions, LLC

Registered with
  • US (FDA)
OrionXR

Hoth Intelligence, Inc.

Registered with
  • US (FDA)
Presero 3D Scanning System

Certis Health

Registered with
  • US (FDA)
REAL Immersive System

Penumbra, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
RelieVRx

Appliedvr, Inc.

Registered with
  • US (FDA)
RelieVRx (Pico G3)

Appliedvr, Inc.

Registered with
  • US (FDA)
Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)

Vivaquant, Inc.

Registered with
  • US (FDA)
Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit

Stryker Corp.

Registered with
  • US (FDA)
SentEP

Sentiar, Inc.

Registered with
  • US (FDA)
SKIA-Head (Model: SKIA-ST00)

Skia, Inc.

Registered with
  • US (FDA)
Smileyscope System (Therapy Mode)

Smileyscope Holding, Inc.

Registered with
  • US (FDA)
SpectoMed (v1.0)

Specto Medical

Registered with
  • US (FDA)
SpineAR SNAP

Surgical Theater, LLC

Registered with
  • US (FDA)
SpineAR SNAP (SyncAR Spine)

Surgical Theater, LLC

Registered with
  • US (FDA)
Spine Navigation System

Medivis, Inc.

Registered with
  • US (FDA)
STELLAR Knee

Polarisar, Inc.

Registered with
  • US (FDA)
SurgicalAR

Medivis, Inc.

Registered with
  • US (FDA)
Surgical Navigation Advanced Platform (SNAP)

Surgical Theater, LLC

Registered with
  • US (FDA)
SuRgical Planner (SRP)

Surgical Theater, LLC

Registered with
  • US (FDA)
SuRgical Planner (SRP) BrainStorm

Surgical Theater, LLC

Registered with
  • US (FDA)
Surgical Reality Viewer

MedicalVR BV

Registered with
  • US (FDA)
SurgiCase Viewer

Materialise N.V

Registered with
  • US (FDA)
  • UK (MHRA)
True 3D Viewer Software

ECHOPIXEL, INC.

Registered with
  • US (FDA)
VERVE

Oculomotor Technologies

Registered with
  • US (FDA)
Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout

Brainlab SE

Registered with
  • US (FDA)
Virtual Occupational Therapy Application (VOTA)

Barron Associates, Inc.

Registered with
  • US (FDA)
VisAR

Novarad Corp.

Registered with
  • US (FDA)
  • AU (TGA)
VRNT

Cognifisense, Inc.

Registered with
  • US (FDA)
VSI HoloMedicine®

apoQlar GmbH

Registered with
  • US (FDA)
  • EU (EUDAMED)
XR90 (XR90-SYS)

Mediview Xr, Inc.

Registered with
  • US (FDA)
xvision Spine System

Augmedics, Ltd.

Registered with
  • US (FDA)
xvision Spine system (XVS)

Augmedics, Ltd.

Registered with
  • US (FDA)
YuGo System

Biogaming , Ltd.

Registered with
  • US (FDA)