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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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NA - 00848486023249

Camera Stand Assembly
MAKO SURGICAL CORP.
209927
In Commercial Distribution

  • 00848486023249 ()
209927

  • Robotic surgical navigation system

NA - 00848486022211

Guidance Module
MAKO SURGICAL CORP.
207110
In Commercial Distribution

  • 00848486022211 ()
207110

  • Robotic surgical navigation 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

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

ApolloVue S100 Image System - 04719878880008

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

  • 04719878880008 ()


  • Dermatological optical coherence tomography 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

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

AESCULAP - 04046964105296

ORTHOPILOT CAP SINGLE-USE MARKERS
Aesculap AG
FS618SU
In Commercial Distribution

  • 04046964105296 ()
  • 04046964105289 ()
FS618SU

  • Robotic surgical navigation system

VELYS - 10705034646015

VELYS™ Camera Station
Medos International Sàrl
451611002
In Commercial Distribution

  • 10705034646015 ()
451611002

  • Robotic surgical navigation system

VELYS - 10705034646008

VELYS™ Robotic-Assist Station
Medos International Sàrl
451611001
In Commercial Distribution

  • 10705034646008 ()
451611001

  • Robotic surgical navigation system
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