TRAJECTORY GUIDE, MODEL # TGX-XXX

FDA 510(k)

FDA Class 2 ·Neurology

KOLIBRI IGS SYSTEMS

FDA 510(k)

FDA Class 2 ·Neurology

SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS

FDA 510(k)

FDA Class 2 ·Neurology

DISPOSABLE REFLECTIVE MARKER SPHERES

FDA 510(k)

FDA Class 2 ·Neurology

7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application

FDA 510(k)

FDA Class 2 ·Neurology

VECTORVISION CT/FLUORO

FDA 510(k)

FDA Class 2 ·Neurology

SURGICASE GUIDE

FDA 510(k)

FDA Class 2 ·Neurology

MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY

FDA 510(k)

FDA Class 2 ·Neurology

SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS

FDA 510(k)

FDA Class 2 ·Neurology

TouchChat HD w/ WordPower App

Basic UDI-DI

EU MDR · Eu Md Class 1 ·PRENTKE ROMICH COMPANY·10 devices

Bacterial/Viral Filter w HME

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Aktiebolaget Ulax·1 device

ADULT-SINGLE-HHW-WITH CB

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Foxxmed Ltd·1 device

ADULT-DUAL-HHW-WITH CB

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Foxxmed Ltd·1 device

MAZOR ROBOTICS LTD.

FDA registration

MAZOR ROBOTICS LTD.·3 products·🇮🇱 Israel

TELIGEN System Navigation Ready Indications

FDA registration

DEPUY SPINE, INC.·3 products·🇺🇸 United States

MAZOR ROBOTICS LTD.

FDA registration

MAZOR ROBOTICS LTD.·3 products·🇮🇱 Israel

ClarifEye Needle

FDA registration

Philips DS North America LLC·3 products·🇺🇸 United States

Isomedix Operations, Inc.

FDA registration

Isomedix Operations, Inc.·3 products·🇺🇸 United States

MAZOR ROBOTICS LTD.

FDA registration

MAZOR ROBOTICS LTD.·3 products·🇮🇱 Israel

SAINT Neuromodulation System

FDA registration

MAGNUS MEDICAL INC.·3 products·🇺🇸 United States