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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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No Description
Tilite
Aero X
In Commercial Distribution

  • 00853316008068 ()


  • Push-rim manual wheelchair, non-bariatric
physIQ convenience kit including mobile relay device pre-loaded with physIQ monitoring software, biosensors, and skin preparation materials.
PHYSIQ, INC
Model X
In Commercial Distribution

  • 00850023120212 ()


  • Electrocardiography telemetric monitoring system
The Via X Anti-Gravity Treadmill is intended to be a used in a clinical setting for standing, walking, or running in place for rehabilitation, or conditioning for individuals that may require or benefit from the use of body weight support.
Lifeward CA, Inc.
Via X
In Commercial Distribution

  • 00850022788031 ()


  • Pneumatic-support treadmill
The Fit X Anti-Gravity Treadmill is intended to be an entry level product used in a clinical setting for standing, walking, or running in place for rehabilitation, or conditioning for individuals that may require or benefit from the use of body weight support
Lifeward CA, Inc.
Fit X
In Commercial Distribution

  • 00850022788017 ()


  • Pneumatic-support treadmill
No Description
SYSMEX CORPORATION
1.X
In Commercial Distribution

  • 04987562488506 ()
AB364503

  • Clinical laboratory information system
Stethee Pro Central Web Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000055 ()


  • Phonocardiograph
  • Stethoscope application software
Stethee Pro Mobile iOS Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000048 ()


  • Phonocardiograph
  • Stethoscope application software
Stethee Pro Mobile Android Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000031 ()


  • Phonocardiograph
  • Stethoscope application software
Accessory to ERT's Asthma Monitor device for professional users
eResearchTechnology GmbH
2.x
In Commercial Distribution

  • 04057155000603 ()


  • Expiratory peak flow meter, digital
Non-powdered patient examination gloves
C&A Marketing, Inc.
X Large
In Commercial Distribution

  • 00843812168458 ()
  • 10843812168455 ()
WVEBNGXL

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
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