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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 Robotic Navigation System - 00850026574180

Instrument Tracker
Fusion Robotics, LLC
1030
In Commercial Distribution

  • 00850026574180 ()


  • Robotic surgical navigation system

REMI Robotic Navigation System - 00850026574159

8mm Guide Sleeve
Fusion Robotics, LLC
1015
In Commercial Distribution

  • 00850026574159 ()


  • Robotic surgical navigation system

REMI Robotic Navigation System - 00850026574142

Guide Tube with Tracker
Fusion Robotics, LLC
1010
In Commercial Distribution

  • 00850026574142 ()


  • Robotic surgical navigation system

REMI Robotic Navigation System - 00850026574135

Registration Array
Fusion Robotics, LLC
1005
In Commercial Distribution

  • 00850026574135 ()


  • Robotic surgical navigation system

NA - 04546540245090

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

  • 04546540245090 ()
6000-010-000

  • Robotic surgical navigation system

NA - 04546540401632

VECTOR CALIBRATION DEVICE
Stryker Leibinger GmbH & Co. KG
6000-008-000
In Commercial Distribution

  • 04546540401632 ()
6000-008-000

  • Robotic surgical navigation system

STRYKER NAV3 - 04546540696427

Stryker NAV3(R) PLATFORM
Stryker Leibinger GmbH & Co. KG
7700-700-000
In Commercial Distribution

  • 04546540696427 ()
7700-700-000

  • Robotic surgical navigation system

ApolloVue S100 Image System - 04719878880008

No Description
APOLLO MEDICAL OPTICS, LTD.
S100-000US
In Commercial Distribution

  • 04719878880008 ()


  • Dermatological optical coherence tomography system

VivoSight - 05060507260012

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

VivoSight - 05060507260005

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
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