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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.
S98-1925-5P1
In Commercial Distribution

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

  • Manometric gastrointestinal motility analysis system
Radiotherapy quality assurance software tool.
DOSISOFT
2.0.10
In Commercial Distribution

  • B501EPIGRAY020010 ()
EP1001

  • Radiation therapy software
Radiotherapy software quality assurance tool
DOSISOFT
2.0.7
In Commercial Distribution

  • B501EPIGRAY020007 ()
2.0.7

  • Radiation therapy software
Radiotherapy software quality assurance tool.
DOSISOFT
2.0.6
In Commercial Distribution

  • B501EPIGRAY020006 ()
2.0.6

  • Radiation therapy software
Transducer Array Layout Planning software
Novocure GmbH
1.1.0
In Commercial Distribution

  • 07290107983136 ()
SW000060

  • Alternating electric field antimitotic cancer treatment system generator
Medoc Main Station Base Software
MEDOC LTD.
MMS
In Commercial Distribution

  • 07290103039011 ()
SW 00012

  • Thermotester, diagnostic
PillCam Software v9.0 WW WS
Given Imaging, Inc.
FGS-0626
In Commercial Distribution

  • 07290101369530 ()


  • Video capsule endoscopy system application software
AR v3.0 Software Upgrade kit
Given Imaging, Inc.
FGS-8031
In Commercial Distribution

  • 07290101369059 ()


  • Manometric gastrointestinal motility analysis system
PillCam Software Upgrade v9 , USA
Given Imaging, Inc.
FGS-0613
In Commercial Distribution

  • 07290101366768 ()


  • Video capsule endoscopy system application software
Sleep disorder interpretive software, professional-only
OXEHEALTH LIMITED
2
In Commercial Distribution

  • 50607514500023 ()


  • Sleep disorder interpretive software, professional-only
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