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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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CT Image Post-Processing Software
Shanghai United Imaging Healthcare Co., Ltd.
uWS-CT
In Commercial Distribution

  • 06971576834020 ()


  • Radiology DICOM image processing application software
MR Image Post-Processing Software
Shanghai United Imaging Healthcare Co., Ltd.
uWS-MR
In Commercial Distribution

  • 06971576834013 ()


  • MRI system application software
SOFTWARE 9735585 STEALTHSTATION CRANIAL
MEDTRONIC NAVIGATION, INC.
9735585
In Commercial Distribution

  • 00763000253165 ()


  • Neurological stereotactic surgery system
DVD SOFTWARE HSCRIBE V6.4.1
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094356878 ()
109202

  • Electrocardiographic long-term ambulatory recording analyser application software
DVD SOFTWARE VISION V6.4.1
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094356861 ()
109203

  • Electrocardiographic long-term ambulatory recording analyser application software
R.I.KNEE 2.1 SOFTWARE KIT
Smith & Nephew, Inc.
ROB10405
In Commercial Distribution

  • 00885556798027 ()
ROB10405

  • Robotic surgical arm system
E-Scribe Oracle Database Software
WELCH ALLYN, INC.
901134
Not in Commercial Distribution

  • 00732094326802 ()
108086

  • Patient health record information system application software
XSCRIBE V6.3.0 SOFTWARE CD
WELCH ALLYN, INC.
901144
Not in Commercial Distribution

  • 00732094320800 ()
419540

  • Electrocardiographic lead set, reusable
Q-STRESS V6.3.0 SOFTWARE CD
WELCH ALLYN, INC.
901144
Not in Commercial Distribution

  • 00732094320794 ()
419449

  • Electrocardiographic lead set, reusable
Software Rest Interp v7.5
WELCH ALLYN, INC.
901155
In Commercial Distribution

  • 00732094319057 ()
107440

  • Electrocardiograph, professional, multichannel
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