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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 - 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

StealthStation Cranial Software - 00763000234867

SFW 9735762 APP STEALTH S8 APPLICATION
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000234867 ()


  • Multi-purpose stereotactic surgery system

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

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

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

Xpresstrak Software Kit - 00886368000513

AXP Accessory
Thermogenesis Corp.
7-00-288
In Commercial Distribution

  • 00886368000513 ()
7-00-288

  • Cryobiological storage container

Telligence Bridge Software - 17350088671426

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

  • 17350088671426 ()


  • Nurse call system

DEXIS™ Software - EKAV101034120

Enterprise
DEXIS LLC
9
In Commercial Distribution

  • EKAV101034120 ()
PLU238

  • Radiology information system application software
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