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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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ASI IVD System - 07290016630046

ASI IVD System with software version GenASIs V-8.4
APPLIED SPECTRAL IMAGING LTD.
GenASIs 8.4
In Commercial Distribution

  • 07290016630046 ()


  • Laboratory analyser operation system software IVD

ASI IVD System - 07290016630039

ASI IVD System with software version GenASIs V-8.3
APPLIED SPECTRAL IMAGING LTD.
GenASIs 8.3
In Commercial Distribution

  • 07290016630039 ()


  • Laboratory analyser operation system software IVD

GenASIs™ System - 07290016630015

No Description
APPLIED SPECTRAL IMAGING LTD.
GenASIs
Not in Commercial Distribution

  • 07290016630015 ()


  • Laboratory analyser operation system software IVD

GenASIs™ System - 07290016630008

No Description
APPLIED SPECTRAL IMAGING LTD.
GenASIs
Not in Commercial Distribution

  • 07290016630008 ()


  • Laboratory analyser operation system software IVD

Microwave Ablation Generator - 06954414674453

Microwave Ablation Generator
Canyon Medical Inc.
KY-2100A
In Commercial Distribution

  • 06954414674453 ()


  • Microwave hyperthermia system

Microwave Ablation Generator - 06954414610024

Microwave Ablation Generator
Canyon Medical Inc.
KY-2000A
In Commercial Distribution

  • 06954414610024 ()


  • Microwave hyperthermia system

Norav 1200 Series PC-ECG - 07290110252663

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - M1 = Continuous Resting-ECG Monitoring The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW M1
In Commercial Distribution

  • 07290110252663 ()
HASP-SW-K-M1-01

  • Patient monitoring system module, electrocardiographic, long-term recording

Norav 1200 Series PC-ECG - 07290110252625

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - I1 = Resting-ECG Measurement Tool The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW I1
In Commercial Distribution

  • 07290110252625 ()
HASP-SW-K-I1-01

  • Cardiovascular risk evaluation interpretive software

Roentgen Files - 00850631008087

Roentgen Files 4.1.0
Brit Systems, LLC
4.1.0
In Commercial Distribution

  • 00850631008087 ()


  • Radiological PACS software
  • Radiology information system application software

Roentgen Files - 00850631008506

Roentgen Files 4.1.1
Brit Systems, LLC
4.1.1
In Commercial Distribution

  • 00850631008506 ()


  • Radiological PACS software
  • Radiology information system application software
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