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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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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
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