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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Focus Thermotherapy Device
Medifocus, Inc.
Original
In Commercial Distribution

  • B0634100145 ()


  • Microwave hyperthermia system
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 with software version GenASIs V-8.3
APPLIED SPECTRAL IMAGING LTD.
GenASIs 8.3
In Commercial Distribution

  • 07290016630039 ()


  • Laboratory analyser operation system software IVD
No Description
APPLIED SPECTRAL IMAGING LTD.
GenASIs
Not in Commercial Distribution

  • 07290016630015 ()


  • Laboratory analyser operation system software IVD
No Description
APPLIED SPECTRAL IMAGING LTD.
GenASIs
Not in Commercial Distribution

  • 07290016630008 ()


  • Laboratory analyser operation system software IVD
Microwave Ablation Generator
Canyon Medical Inc.
KY-2100A
In Commercial Distribution

  • 06954414674453 ()


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

  • 06954414610024 ()


  • Microwave hyperthermia system
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 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 4.1.0
Brit Systems, LLC
4.1.0
In Commercial Distribution

  • 00850631008087 ()


  • Radiological PACS software
  • Radiology information system application software
Roentgen Files 4.1.1
Brit Systems, LLC
4.1.1
In Commercial Distribution

  • 00850631008506 ()


  • Radiological PACS software
  • Radiology information system application software
No Description
VINEHEALTH DIGITAL LIMITED
R1 V3
In Commercial Distribution

  • 05070000764115 ()


  • Medication reminder application software
  • Clinical management support software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10909201
In Commercial Distribution

  • 04056869041087 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10909200
In Commercial Distribution

  • 04056869041070 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10909199
In Commercial Distribution

  • 04056869041063 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10909198
In Commercial Distribution

  • 04056869041056 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10909197
In Commercial Distribution

  • 04056869041049 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10909196
In Commercial Distribution

  • 04056869041032 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10764034
In Commercial Distribution

  • 04056869027456 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10764033
In Commercial Distribution

  • 04056869027449 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10748569
In Commercial Distribution

  • 04056869013817 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10748579
In Commercial Distribution

  • 04056869013770 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10273987
In Commercial Distribution

  • 04056869002170 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10764040
In Commercial Distribution

  • 04056869002156 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10763972
In Commercial Distribution

  • 04056869002149 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10763971
In Commercial Distribution

  • 04056869002132 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08716669
In Commercial Distribution

  • 04056869002118 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08716511
In Commercial Distribution

  • 04056869002101 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431561
In Commercial Distribution

  • 04056869950181 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431560
In Commercial Distribution

  • 04056869950174 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431559
In Commercial Distribution

  • 04056869950167 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431558
In Commercial Distribution

  • 04056869950150 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431557
In Commercial Distribution

  • 04056869950143 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431527
In Commercial Distribution

  • 04056869243351 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431532
In Commercial Distribution

  • 04056869243405 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431531
In Commercial Distribution

  • 04056869243399 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431530
In Commercial Distribution

  • 04056869243382 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431529
In Commercial Distribution

  • 04056869243375 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431528
In Commercial Distribution

  • 04056869243368 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11298565
In Commercial Distribution

  • 04056869147925 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11298564
In Commercial Distribution

  • 04056869147918 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11298563
In Commercial Distribution

  • 04056869147901 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11298562
In Commercial Distribution

  • 04056869147895 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11298561
In Commercial Distribution

  • 04056869147888 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11298560
In Commercial Distribution

  • 04056869147871 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10183755
In Commercial Distribution

  • 04056869002453 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10183752
In Commercial Distribution

  • 04056869002446 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10183312
In Commercial Distribution

  • 04056869002408 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10764039
In Commercial Distribution

  • 04056869002286 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10764035
In Commercial Distribution

  • 04056869002262 ()


  • SPECT system application software
  • PET system application software
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