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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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ZVU® Functional GI Software
DIVERSATEK HEALTHCARE, INC.
ZVU-3
In Commercial Distribution

  • 00816734022825 ()
ZVU-3

  • Manometric gastrointestinal motility analysis system
Bioview® Manometry Acquisition Software
DIVERSATEK HEALTHCARE, INC.
S98-1925-7P1
In Commercial Distribution

  • 00816734022139 ()
  • B019S9819257P10 ()
S98-1925-7P1

  • Manometric gastrointestinal motility analysis system
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
Mega Power Software Calibration Kit
MEGADYNE MEDICAL PRODUCTS, INC.
1900
Not in Commercial Distribution

  • 10614559104682 ()


  • Electrosurgical system generator
X-Guide 3.6.0 Linux Software (MDR)
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022920 ()


  • Surgical planning/navigation-enhancement system
X-Guide Windows Planning Software 2.3.3
XNAV TECHNOLOGIES LLC
P008296
In Commercial Distribution

  • 00817421020803 ()
P008296

  • Dental treatment application software
X-Guide System Software Version 2.3.0
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421020797 ()
P008542

  • Surgical planning/navigation-enhancement system
Ortho Guidance Versatile Hip Software
Stryker Leibinger GmbH & Co. KG
6007-700-000
In Commercial Distribution

  • 07613327542868 ()
6007-700-000

  • Robotic surgical navigation system application software
Ortho Guidance Express Knee Software
Stryker Leibinger GmbH & Co. KG
6003-710-000
In Commercial Distribution

  • 07613327542332 ()
6003-710-000

  • Robotic surgical navigation system application software
Ortho Guidance Precision Knee Software
Stryker Leibinger GmbH & Co. KG
6003-700-000
In Commercial Distribution

  • 07613327541809 ()
6003-700-000

  • Robotic surgical navigation system application software
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
AuraFit Fitting Software v4.x
Unitron Hearing Division
058-5236
In Commercial Distribution

  • 07613389303292 ()
058-5236

  • Audiometric/hearing device software
TrueFit Fitting Software v4.x
Unitron Hearing Division
058-5235
In Commercial Distribution

  • 07613389303285 ()
058-5235

  • Audiometric/hearing device software
Synergy Matrix Core Software License
ARTHREX, INC.
AR-3200-1053
In Commercial Distribution

  • 00888867384866 ()
AR-3200-1053

  • Multidisciplinary medical image management software
Synergy.Net HL7 Software Single License
ARTHREX, INC.
AR-3200-1047
In Commercial Distribution

  • 00888867226975 ()
AR-3200-1047

  • Medical image management system
PROFESS(TM) SOFTWARE SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-81033
In Commercial Distribution

  • 07613327071955 ()
81-81033

  • Robotic surgical navigation system application software
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