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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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REMI 5.5 mm Cann. Dual Lead Tap
Fusion Robotics, LLC
1355
In Commercial Distribution

  • 00850026574685 ()


  • Robotic surgical navigation system
REMI 5.0 mm Cann. Dual Lead Tap
Fusion Robotics, LLC
1350
In Commercial Distribution

  • 00850026574678 ()


  • Robotic surgical navigation system
REMI 4.5 mm Cann. Dual Lead Tap
Fusion Robotics, LLC
1345
In Commercial Distribution

  • 00850026574661 ()


  • Robotic surgical navigation system
100mm x 6mm PSIS Pin
Fusion Robotics, LLC
6026
In Commercial Distribution

  • 00850026574579 ()


  • Robotic surgical navigation system
150mm x 6mm PSIS Pin
Fusion Robotics, LLC
6025
In Commercial Distribution

  • 00850026574555 ()


  • Robotic surgical navigation system
Camera Yoke
Fusion Robotics, LLC
3007
In Commercial Distribution

  • 00850026574357 ()


  • Robotic surgical navigation system
Remi Robotic Navigation System
Fusion Robotics, LLC
PN-001
In Commercial Distribution

  • 00850026574340 ()


  • Robotic surgical navigation system
Camera Assembly
Fusion Robotics, LLC
3005
In Commercial Distribution

  • 00850026574333 ()


  • Robotic surgical navigation system
Reference Arm
Fusion Robotics, LLC
1065
In Commercial Distribution

  • 00850026574241 ()


  • Robotic surgical navigation system
Instrument Tracker
Fusion Robotics, LLC
1030
In Commercial Distribution

  • 00850026574180 ()


  • Robotic surgical navigation system
8mm Guide Sleeve
Fusion Robotics, LLC
1015
In Commercial Distribution

  • 00850026574159 ()


  • Robotic surgical navigation system
Guide Tube with Tracker
Fusion Robotics, LLC
1010
In Commercial Distribution

  • 00850026574142 ()


  • Robotic surgical navigation system
Registration Array
Fusion Robotics, LLC
1005
In Commercial Distribution

  • 00850026574135 ()


  • Robotic surgical navigation system
Robotic Arm & Accessories
Microport Navibot International LLC
10008NBSUB
In Commercial Distribution

  • 00850030914026 ()
10008NBSUB

  • Robotic surgical navigation system
Surgical Console
Microport Navibot International LLC
10012NB
In Commercial Distribution

  • 10850030914016 ()
  • 00850030914019 ()
10012NB

  • Robotic surgical navigation system
Navigation Trolley Assembly
Microport Navibot International LLC
10016NB
In Commercial Distribution

  • 10850030914009 ()
  • 00850030914002 ()
10016NB

  • Robotic surgical navigation system
The VivoSight Dx is indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body. This indicated use allows imaging of tissue microstructure including skin, and enables detection and display of regions within the scanned area that are in motion (Dynamic OCT) to aid trained and competent clinicians in their assessment of a patient's clinical conditions.
MICHELSON DIAGNOSTICS LTD
VivoSight Dx
In Commercial Distribution

  • 05060507260012 ()


  • Dermatological optical coherence tomography system
The VivoSight Topical OCT system is indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body. This indicated use allows imaging of tissue microstructure, including skin, to aid trained and competent clinicians in their assessment of a patient's clinical conditions.
MICHELSON DIAGNOSTICS LTD
VivoSight
In Commercial Distribution

  • 05060507260005 ()


  • Dermatological optical coherence tomography system
No Description
Brainlab AG
20100131
Not in Commercial Distribution

  • 04260583190017 ()


  • Robotic surgical navigation system
POINT CALIBRATION DEVICE (PCD)
Stryker Leibinger GmbH & Co. KG
6000-010-000
In Commercial Distribution

  • 04546540245090 ()
6000-010-000

  • Robotic surgical navigation system
The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures
QUANTUM SURGICAL
30-0001
In Commercial Distribution

  • 03760305400086 ()
30-0001-01-USA

  • Robotic surgical navigation system
The Navigation Probe is an instrument of the EPIONE device. It enables visualizing reference points or anatomical landmarks in the medical images. It allows the verification of patient registration accuracy, using external anatomical landmarks or skin markers.
QUANTUM SURGICAL
02-0044
In Commercial Distribution

  • 03760305400079 ()
02-0044

  • Robotic surgical navigation system
The Needle Guide is an instrument of the EPIONE device. It provides mechanical guidance for rigid straight instruments of a range of external diameter specified in the Technical Specifications.
QUANTUM SURGICAL
02-0027
In Commercial Distribution

  • 03760305400062 ()
02-0027-19G

  • Robotic surgical navigation system
The Navigation Probe is an instrument of the EPIONE device. It enables visualizing reference points or anatomical landmarks in the medical images. It allows the verification of patient registration accuracy, using external anatomical landmarks or skin markers.
QUANTUM SURGICAL
02-0031
Not in Commercial Distribution

  • 03760305400055 ()
02-0031

  • Robotic surgical navigation system
The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures.
QUANTUM SURGICAL
30-0001 v1.0.2
In Commercial Distribution

  • 03760305400031 ()


  • Robotic surgical navigation system
The Patient Reference is an instrument of the EPIONE device used to track the patient position and motions including breathing.
QUANTUM SURGICAL
02-0026
In Commercial Distribution

  • 03760305400024 ()
02-0026

  • Robotic surgical navigation system
ORTHOPILOT CAP SINGLE-USE MARKERS
Aesculap AG
FS618SU
In Commercial Distribution

  • 04046964105296 ()
  • 04046964105289 ()
FS618SU

  • Robotic surgical navigation system
STATION
Exactech, Inc.
I00020
In Commercial Distribution

  • 10885862252821 ()

  • V2
I00020

  • Robotic surgical navigation system
Station V3 Disposable Kit
Exactech, Inc.
A10032
In Commercial Distribution

  • 10885862632715 ()
A10032

  • Robotic surgical navigation system
Station V3 Carrying Case
Exactech, Inc.
I00032
In Commercial Distribution

  • 10885862628961 ()
I00032

  • Robotic surgical navigation system
Station V3 Power Supply
Exactech, Inc.
I00031
In Commercial Distribution

  • 10885862628954 ()
I00031

  • Robotic surgical navigation system
Station V3
Exactech, Inc.
I00030
In Commercial Distribution

  • 10885862628947 ()
I00030

  • Robotic surgical navigation system
No Description
Exactech, Inc.
Diamond Tracker2 G
In Commercial Distribution

  • 10885862607195 ()

  • G
A00206

  • Robotic surgical navigation system
No Description
Exactech, Inc.
Diamond Tracker2 T
In Commercial Distribution

  • 10885862607188 ()

  • T
A00205

  • Robotic surgical navigation system
No Description
Exactech, Inc.
Diamond Tracker2 F
In Commercial Distribution

  • 10885862607171 ()

  • F
A00204

  • Robotic surgical navigation system
No Description
Exactech, Inc.
Probe Tracker2 P
In Commercial Distribution

  • 10885862607164 ()

  • P
A00203

  • Robotic surgical navigation system
TRAVEL CASE
Exactech, Inc.
I00022
In Commercial Distribution

  • 10885862266675 ()

  • V2
I00022

  • Robotic surgical navigation system
POWER SUPPLY
Exactech, Inc.
I00021
In Commercial Distribution

  • 10885862266668 ()

  • V2
I00021

  • Robotic surgical navigation system
IMPLANT KIT
Exactech, Inc.
A10012
In Commercial Distribution

  • 10885862266651 ()

  • V2
A10012

  • Robotic surgical navigation system
SOFTWARE APPLICATION, TOTAL SHOULDER PLANNING
Exactech, Inc.
L00041
In Commercial Distribution

  • 10885862518767 ()
L00041

  • Robotic surgical navigation system
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