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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
SWORD HEALTH, S.A.
SWORDPhoenix-14
In Commercial Distribution

  • 05600775530143 ()


  • Virtual-display rehabilitation system, non-supportive, home-use
No Description
SWORD HEALTH, S.A.
SWORDPhoenix-13
In Commercial Distribution

  • 05600775530136 ()


  • Virtual-display rehabilitation system, non-supportive, home-use
No Description
SWORD HEALTH, S.A.
SWORD Phoenix 2.0 5MTs
In Commercial Distribution

  • 05600775530051 ()


  • Virtual-display rehabilitation system, non-supportive, home-use
No Description
SWORD HEALTH, S.A.
SWORD Phoenix 2.0 2MTs
In Commercial Distribution

  • 05600775530044 ()


  • Virtual-display rehabilitation system, non-supportive, home-use
No Description
KINETIKOS - DRIVEN SOLUTIONS, S.A.
0,1
In Commercial Distribution

  • 05600638781835 ()


  • Biomechanical function analysis/rehabilitation software
The KinetikOS software is a cloud-based software as a medical device (SaMD) that utilizes data generated by various sensors from portable or wearable consumer electronics such as smartphones and smartwatches and provides gait-related data analytics. Gait-related measurements and analytics are provided to compatible 3rd-party software via APIs for displaying data, generating reports, performing further analysis and/or integrating data into their digital health software or apps, for the purpose of monitoring and understanding individual user’s general mobility or gait-related health conditions by qualified healthcare providers.
KINETIKOS - DRIVEN SOLUTIONS, S.A.
0,1
In Commercial Distribution

  • 05600638781828 ()


  • Biomechanical function analysis/rehabilitation software
IVC BIRDIE EVO COMPACT FULL BODY LIFT
INVACARE CORPORATION
BRDCOMPACT
In Commercial Distribution

  • 05600494138743 ()


  • Mobile patient lifting system, electrically-powered
WUNDER RS300 PATIENT SCALE BIRDIE EVO XPLUS
INVACARE CORPORATION
BLS5
In Commercial Distribution

  • 05600494138736 ()


  • Patient sling scale
INVACARE ISA COMPACT STAND-UP LIFT
INVACARE CORPORATION
ISACOMPACT
In Commercial Distribution

  • 05600494138712 ()


  • Mobile patient lifting system, electrically-powered
INVACARE ISA XPLUS STAND-UP LIFT
INVACARE CORPORATION
ISAXPLUS
In Commercial Distribution

  • 05600494138705 ()


  • Mobile patient lifting system, electrically-powered
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