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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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Bioview® Manometry Acquisition Software
DIVERSATEK HEALTHCARE, INC.
S98-1925-6P1
In Commercial Distribution

  • 00816734022122 ()
  • B019S9819256P10 ()
S98-1925-6P1

  • Manometric gastrointestinal motility analysis system
Bioview® Manometry Acquisition Software
DIVERSATEK HEALTHCARE, INC.
S98-1925-5P1
In Commercial Distribution

  • 00816734022115 ()
  • B019S9819255P10 ()
S98-1925-5P1

  • Manometric gastrointestinal motility analysis system
Bio Impedance analysis software ROW
IMPEDIMED LIMITED
5.5.0.1
In Commercial Distribution

  • B277299SFB7CD1 ()
  • B277299SFB7CD0 ()
299-SFB7CD

  • Bioelectrical body composition analyser
Bio Impedence analysis software US
IMPEDIMED LIMITED
5.5.0
In Commercial Distribution

  • B277293SFB7CD0 ()
  • B277293SFB7CD1 ()
293-SFB7CD

  • Bioelectrical body composition analyser
DF50 Body Composition Analysis Software
IMPEDIMED LIMITED
4.1.2
Not in Commercial Distribution

  • B277292DF50CD1 ()
  • B277292DF50CD0 ()
  • B277292DF50CD2 ()
292-DF50CD

  • Bioelectrical body composition analyser
CloudDR™ Medical System Software
Cuattro Medical
SWR-00021-MD
In Commercial Distribution

  • B269SWR00021MD0 ()


  • Radiological PACS software
Software for analysis of echocardiogram
EPSILON IMAGING
3.2.0
Not in Commercial Distribution

  • B557ECHOINSIGHT0 ()


  • Cardiac mapping system application software
Software, Delivery Analysis, Version 1.2.2
ACCURAY INCORPORATED
1064315
In Commercial Distribution

  • M65810643150 ()
NA

  • Linear accelerator system
Software, Delivery Analysis, Version 1.2.1
ACCURAY INCORPORATED
1062213
In Commercial Distribution

  • M65810622130 ()
NA

  • Linear accelerator system
Software, Delivery Analysis, Version 1.2
ACCURAY INCORPORATED
1057375
In Commercial Distribution

  • M65810573750 ()
NA

  • Linear accelerator system
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