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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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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
Lumax™ Software Update pack
Coopersurgical, Inc.
53361
In Commercial Distribution

  • 60888937013445 ()


  • Urodynamic measurement system
RIS SOFTWARE < 25K EXAMS / YEAR
CARESTREAM HEALTH, INC.
Vue RIS
In Commercial Distribution

  • 60889978671366 ()
8671364

  • Radiology information system application software
PROFESS(TM) SOFTWARE SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-81033
In Commercial Distribution

  • 07613327071955 ()
81-81033

  • Robotic surgical navigation system application software
ADAPT 2.0 for Gamma3 Software
Stryker GmbH
0101-0001
In Commercial Distribution

  • 07613327311822 ()
0101-0001

  • Medical image management 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
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