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

  • 00763000234867 ()


  • Multi-purpose stereotactic surgery system
SFW KIT 9735737 STEALTH S8 CRANIAL EU-SW
MEDTRONIC NAVIGATION, INC.
9735737
In Commercial Distribution

  • 00763000234812 ()


  • Neurological stereotactic surgery system
SFW KIT 9735737 STEALTH S8 CRANIAL
MEDTRONIC NAVIGATION, INC.
9735737
In Commercial Distribution

  • 00763000234799 ()


  • Neurological stereotactic surgery system
PRODUCT SOFTWARE MMT-7350 V2.2A
MEDTRONIC MINIMED, INC.
MMT-7350
In Commercial Distribution

  • 00763000242787 ()


  • Patient health record information system application software
SFW KIT 9735738 STEALTH S8 CRN DBS
MEDTRONIC NAVIGATION, INC.
9735738
In Commercial Distribution

  • 00763000238902 ()


  • Neurological stereotactic surgery system
SFW KIT 9735736 STEALTH S8 ENT
MEDTRONIC NAVIGATION, INC.
9735736
In Commercial Distribution

  • 00763000238810 ()


  • ENT stereotactic surgery system
SFW KIT 9735739 STEALTH S8 STEREOTX
MEDTRONIC NAVIGATION, INC.
9735739
In Commercial Distribution

  • 00763000238650 ()


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

  • 15060484490102 ()


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

  • 17350088671426 ()


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

  • 07290101369578 ()


  • Manometric gastrointestinal motility analysis system
PillCam Software v9.0, USA
Given Imaging, Inc.
FGS-0612
In Commercial Distribution

  • 07290101366751 ()


  • Video capsule endoscopy system application software
CLT v3.0 software upgrade
Given Imaging, Inc.
FGS-0580
In Commercial Distribution

  • 07290101366102 ()


  • Manometric gastrointestinal motility analysis system
v3.0 software kit upgrade
Given Imaging, Inc.
FGS-0573
In Commercial Distribution

  • 07290101365945 ()


  • Manometric gastrointestinal motility analysis system
CLT v3.0 software kit
Given Imaging, Inc.
FGS-0572
In Commercial Distribution

  • 07290101365938 ()


  • Manometric gastrointestinal motility analysis system
AR v3.0 Software kit
Given Imaging, Inc.
FGS-8030
In Commercial Distribution

  • 07290101365785 ()


  • Manometric gastrointestinal motility analysis system
Blue Sky Plan Software
BLUE SKY BIO LLC
5.0
In Commercial Distribution

  • 00810060226346 ()
BSP

  • Dental treatment application software
Blue Sky Plan Software
BLUE SKY BIO LLC
4.13
In Commercial Distribution

  • 00810060226063 ()
BSP

  • Dental treatment application software
iTero Lumina Pro Software
Align Technology, Inc.
225979
In Commercial Distribution

  • 00816063023067 ()


  • CAD/CAM software
Diana Web Server Software
ICU MEDICAL, INC.
DS2800-04-01
In Commercial Distribution

  • 00887709126770 ()
DS2800-04-01

  • Pharmaceutical fluid-dispensing system
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