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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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ML 830® - 00859626006190

DC Console Activation Card
MICROLIGHT CORPORATION OF AMERICA
ML-830-04-002
In Commercial Distribution

  • 00859626006190 ()
ML-830-04-002

  • Laser application software

Interacoustics - 05711117180497

No Description
Interacoustics A/S
2D-VOGfw
In Commercial Distribution

  • 05711117180497 ()


  • Camera application software

Interacoustics - 05711117199765

No Description
Interacoustics A/S
Viot Suite
In Commercial Distribution

  • 05711117199765 ()


  • Camera application software

Engage Medical Device Alarm Notification System (EMDAN) - 00860002177786

No Description
STRYKER CORPORATION
EMDAN 2.3.1
In Commercial Distribution

  • 00860002177786 ()
910-01957

  • Alarm application software

InTandem Education Unit - 00860001790825

Education Unit for InTandem
Medrhythms, Inc.
001EDU
In Commercial Distribution

  • 00860001790825 ()


  • Neuromuscular rehabilitation software

InTandem - 00860001790801

InTandem is indicated to improve walking and ambulation in adult chronic stroke patients. InTandem is intended to be used in the home for the physical rehabilitation of ambulatory adults with chronic stroke walking impairments.
Medrhythms, Inc.
0010
In Commercial Distribution

  • 00860001790801 ()


  • Neuromuscular rehabilitation software

ChartCheck - 00860001672749

ChartCheck assists in quality assessment of radiotherapy treatment plans and on treatment chart review utilizing treatment, imaging, and documentation data in a simple, web-based interface.
Radformation, Inc
1.2
In Commercial Distribution

  • 00860001672749 ()


  • Radiation therapy software

AutoContour - 00860001672732

AutoContour is intended to assist radiation treatment planners in contouring and reviewing structures within medical images in preparation for radiation therapy treatment planning.
Radformation, Inc
2.0
In Commercial Distribution

  • 00860001672732 ()


  • Radiation therapy software

ClearCalc - 00860001672725

ClearCalc is a software intended to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm.
Radformation, Inc
2.0
In Commercial Distribution

  • 00860001672725 ()


  • Radiation therapy software

EZFluence - 00860001672718

EZFluence is intended to assist radiation treatment planning professionals in generating optimal fluences for producing a homogeneous dose distribution in external beam radiation therapy treatment plans consisting of photo treatment fields.
Radformation, Inc
2.3
In Commercial Distribution

  • 00860001672718 ()


  • Radiation therapy software
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