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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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Clinician's Programming Interface - 00840094454330

No Description
Advanced Bionics, LLC
AB-6500
In Commercial Distribution



  • Hearing implant implantable-component tester, postoperative

Large Sapphire Optic - 00841494100162

Vectus Large Sapphire Optic Refurbished
Cynosure, LLC
3520C-0002R
In Commercial Distribution

  • 00841494100162 ()


  • Dermatological Raman spectroscopy system

Large Sapphire Optic - 00841494100155

Vectus Large Sapphire Optic
Cynosure, LLC
3520C-0002
In Commercial Distribution

  • 00841494100155 ()


  • Dermatological Raman spectroscopy system

Small Sapphire Optic - 00841494100148

Vectus Small Sapphire Optic
Cynosure, LLC
3520A-0003
In Commercial Distribution

  • 00841494100148 ()


  • Dermatological Raman spectroscopy system

Vectus Diode Handpiece - 00841494100131

Vectus Diode Handpiece
Cynosure, LLC
3520A-0001
In Commercial Distribution

  • 00841494100131 ()


  • Dermatological Raman spectroscopy system

Vectus - 00841494100124

Vectus Laser Assembly
Cynosure, LLC
105-3500-000
In Commercial Distribution

  • 00841494100124 ()


  • Dermatological Raman spectroscopy system

EVASOFT - D83399924908000

EVASOFT IMAGING SOFTWARE
ImageWorks
9992490800
In Commercial Distribution

  • D83399924908000 ()
9992490800

  • General-purpose dental x-ray system application software

EVA SELECT - D83399924122050

EVA SELECT SIZE 2 SENSOR
ImageWorks
9992412205
In Commercial Distribution

  • D83399924122050 ()
9992412205

  • General-purpose dental x-ray system application software

EVA SELECT - D83399924121050

EVA SELECT SIZE 1 SENSOR
ImageWorks
9992412105
In Commercial Distribution

  • D83399924121050 ()
9992412105

  • General-purpose dental x-ray system application software

VITOM - 04048551347188

VITOM® II NIR/ICG Telescope 0°
Karl Storz GmbH & Co. KG
20916025AGA
In Commercial Distribution

  • 04048551347188 ()


  • Surgical microscope video camera, sterilizable

VITOM - 04048551324745

VITOM® Telescope 0° w Integ. Illuminator
Karl Storz GmbH & Co. KG
20916025AA
In Commercial Distribution

  • 04048551324745 ()


  • Surgical microscope video camera, sterilizable

VITOM - 04048551324738

VITOM® Tel. 90° w Integ. Illuminator
Karl Storz GmbH & Co. KG
20916025DA
In Commercial Distribution

  • 04048551324738 ()


  • Surgical microscope video camera, sterilizable

Apex Cloud Software - D875403051

A cloud-based, PACS-server software application that gives dental organizations web access to patient images that have been captured from any DICOM-enabled device.
MASTERLINK LLC
1
In Commercial Distribution

  • D875403051 ()


  • General-purpose dental x-ray system application software

Apex Capture Software - D875400101

Dental imaging capture, enhance and display software.
MASTERLINK LLC
1
In Commercial Distribution

  • D875400101 ()


  • General-purpose dental x-ray system application software

Small Sapphire Optic - 00841494100636

Vectus Small Sapphire Optic Refurbished
Cynosure, LLC
3520A-0003R
In Commercial Distribution

  • 00841494100636 ()


  • Dermatological Raman spectroscopy system

Vectus Diode Handpiece - 00841494100612

Vectus Handpiece Refurbished
Cynosure, LLC
3520A-0001R
In Commercial Distribution

  • 00841494100612 ()


  • Dermatological Raman spectroscopy system

VEA Align - 03663999000337

No Description
EOS IMAGING
2.1
In Commercial Distribution

  • 03663999000337 ()


  • Basic diagnostic x-ray system application software

VEA Align - 03663999000290

No Description
EOS IMAGING
1.0
Not in Commercial Distribution

  • 03663999000290 ()


  • Basic diagnostic x-ray system application software

sterEOS - 03663999000153

No Description
EOS IMAGING
1.10
In Commercial Distribution

  • 03663999000153 ()


  • Basic diagnostic x-ray system application software

sterEOS® - 03663999000054

sterEOS workstation software
EOS IMAGING
Software 1.8
In Commercial Distribution

  • 03663999000054 ()


  • Basic diagnostic x-ray system application software

sterEOS® - 03663999000047

sterEOS workstation
EOS IMAGING
Workstation 1.8
In Commercial Distribution

  • 03663999000047 ()


  • Basic diagnostic x-ray system application software

sterEOS® - 03663999000030

sterEOS workstation software
EOS IMAGING
Software 1.6
In Commercial Distribution

  • 03663999000030 ()


  • Basic diagnostic x-ray system application software

sterEOS® - 03663999000023

sterEOS workstation
EOS IMAGING
Workstation 1.6
In Commercial Distribution

  • 03663999000023 ()


  • Basic diagnostic x-ray system application software

FDR Clinica - 08800011121372

480V3~ / 125kV
DRGEM Corporation
FDR Clinica FGXR-40S
In Commercial Distribution

  • 08800011121372 ()


  • Stationary basic diagnostic x-ray system, analogue

FDR Clinica - 08800011121358

400V3~ / 125kV
DRGEM Corporation
FDR Clinica FGXR-40S
In Commercial Distribution

  • 08800011121358 ()


  • Stationary basic diagnostic x-ray system, analogue

FDR Clinica - 08800011121341

380V3~ / 150kV
DRGEM Corporation
FDR Clinica FGXR-40S
In Commercial Distribution

  • 08800011121341 ()


  • Stationary basic diagnostic x-ray system, analogue

FDR Clinica - 08800011121334

380V3~ / 125kV
DRGEM Corporation
FDR Clinica FGXR-40S
In Commercial Distribution

  • 08800011121334 ()


  • Stationary basic diagnostic x-ray system, analogue

FDR Clinica - 08800011121310

220-230V~ / 125kV
DRGEM Corporation
FDR Clinica FGXR-40S
In Commercial Distribution

  • 08800011121310 ()


  • Stationary basic diagnostic x-ray system, analogue

FDR Clinica - 08800011121297

480V3~ / 125kV
DRGEM Corporation
FDR Clinica FGXR-32S
In Commercial Distribution

  • 08800011121297 ()


  • Stationary basic diagnostic x-ray system, analogue

FDR Clinica - 08800011121273

380V3~ / 125kV
DRGEM Corporation
FDR Clinica FGXR-32S
In Commercial Distribution

  • 08800011121273 ()


  • Stationary basic diagnostic x-ray system, analogue
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