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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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Automated sleep scoring software.
ENSODATA, INC.
01.1
Not in Commercial Distribution

  • 00864458000407 ()


  • Sleep disorder interpretive software, professional-only
Secondary Check QA Software
VARIAN MEDICAL SYSTEMS, INC.
2.0.1
Not in Commercial Distribution

  • 00861334000315 ()
Mobius3D

  • Accelerator system quality assurance device
SCB control NEO Software
Karl Storz GmbH & Co. KG
20090001-47
In Commercial Distribution

  • 04048551392270 ()


  • Operating room audiovisual data/device management system application software
ORTHOPILOT SOFTWARE COLUMBUS TKR
Aesculap AG
FS222
Not in Commercial Distribution

  • 04046963492083 ()
FS222

  • Robotic surgical navigation system application software
Software for spine navigation
Brainlab AG
1,5
In Commercial Distribution

  • 04056481142025 ()


  • Robotic surgical navigation system
ORTHOPILOT SOFTWARE THA ACA
Aesculap AG
FS229
Not in Commercial Distribution

  • 04046963989101 ()
FS229

  • Robotic surgical navigation system application software
ORTHOPILOT SOFTWARE TKA SMART
Aesculap AG
FS228
Not in Commercial Distribution

  • 04046963977979 ()
FS228

  • Robotic surgical navigation system application software
ORTHOPILOT SOFTWARE TKA VEGA
Aesculap AG
FS226
Not in Commercial Distribution

  • 04046963895853 ()
FS226

  • Robotic surgical navigation system application software
TRUEmanager Diabetes Management Software
TRIVIDIA HEALTH, INC.
TRUEmanager Diabetes Management Software
In Commercial Distribution

  • 00021292008666 ()
RM9NPD78

  • Self-care monitoring/reporting software
Medical Device Software Application
Airstrip Technologies, Inc.
2003
In Commercial Distribution

  • B15320030 ()


  • Bedside monitor remote-viewing software, physiological parameter
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