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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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StealthStation Cranial Software - 00763000234812

SFW KIT 9735737 STEALTH S8 CRANIAL EU-SW
MEDTRONIC NAVIGATION, INC.
9735737
In Commercial Distribution

  • 00763000234812 ()


  • Neurological stereotactic surgery system

StealthStation Cranial Software - 00763000234799

SFW KIT 9735737 STEALTH S8 CRANIAL
MEDTRONIC NAVIGATION, INC.
9735737
In Commercial Distribution

  • 00763000234799 ()


  • Neurological stereotactic surgery system

CareLink™ Software - 00763000242787

PRODUCT SOFTWARE MMT-7350 V2.2A
MEDTRONIC MINIMED, INC.
MMT-7350
In Commercial Distribution

  • 00763000242787 ()


  • Patient health record information system application software

StealthStation Cranial Software - 00763000238902

SFW KIT 9735738 STEALTH S8 CRN DBS
MEDTRONIC NAVIGATION, INC.
9735738
In Commercial Distribution

  • 00763000238902 ()


  • Neurological stereotactic surgery system

StealthStation Cranial Software - 00763000238810

SFW KIT 9735736 STEALTH S8 ENT
MEDTRONIC NAVIGATION, INC.
9735736
In Commercial Distribution

  • 00763000238810 ()


  • ENT stereotactic surgery system

StealthStation Cranial Software - 00763000238650

SFW KIT 9735739 STEALTH S8 STEREOTX
MEDTRONIC NAVIGATION, INC.
9735739
In Commercial Distribution

  • 00763000238650 ()


  • Neurological stereotactic surgery system

moorVMS-TREND PC Software - 15060484490164

moorVMS-TREND PC software is intended for use with moorVMS-LDF and moorVMS-OXY, for long term blood flow and tissue oxygen trend monitoring. It is intended for a variety of physiological and clinical research applications in clinical settings. The clinical value of measurements in disease states has not been established. The moorVMS-TREND is not intended to be used as the sole basis for diagnosis or therapy. The moorVMS-TREND Software is not intended for critical care monitoring where loss of function could result in harm to the patient.
MOOR INSTRUMENTS LIMITED
1
In Commercial Distribution

  • 15060484490164 ()


  • Tissue saturation oximeter
  • Laser Doppler blood flowmeter

moorVMS-VASC PC Software - 15060484490102

Clinical software for micro vascular assessments in physiological research and clinical applications.
MOOR INSTRUMENTS LIMITED
2
In Commercial Distribution

  • 15060484490102 ()


  • Laser Doppler blood flowmeter

Telligence Bridge Software - 17350088671426

SW000795 NGTELL7x-S Telligence Bridge Software, v7.4+
Ascom (Sweden) AB
7.x
In Commercial Distribution

  • 17350088671426 ()


  • Nurse call system

ManoView - 07290101369578

ManoView ESO Software v3.3
Given Imaging, Inc.
FGS-0628
In Commercial Distribution

  • 07290101369578 ()


  • Manometric gastrointestinal motility analysis system
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