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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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IMPAX Software 6.X
Agfa HealthCare NV
6
In Commercial Distribution



  • Radiological PACS software
SOFTWARE C-TUNE II 4.7
Widex A/S
C-Tune II 4.7
In Commercial Distribution

  • 05714880239171 ()
21038007

  • Audiometric/hearing device software
Genie Medical fitting software
Oticon Medical AB
M50504
In Commercial Distribution

  • 05712149000777 ()
M50504

  • Audiometric/hearing device software
Messenger 5.18.3 Software Release
SPOK INC.
5.18.3
In Commercial Distribution

  • 00860011811930 ()


  • Alarm application software
Messenger 6.1.0 Software Release
SPOK INC.
6.1.0
In Commercial Distribution

  • 00860011811923 ()


  • Alarm application software
Messenger 5.18.2 Software Release
SPOK INC.
5.18.2
In Commercial Distribution

  • 00860011811916 ()


  • Alarm application software
Messenger 5.17.16 Software Release
SPOK INC.
5.17.16
In Commercial Distribution

  • 00860011811909 ()


  • Alarm application software
Patient Monitoring Software/System
Gastroklenz Inc.
04PD001
In Commercial Distribution

  • 00860006810238 ()


  • Peritoneal dialysis system
Dental Cloud Imaging Software
Sota Cloud Corp.
1
In Commercial Distribution

  • 00860013687632 ()


  • General-purpose dental x-ray system application software
Messenger 6.1.1 Software Release
SPOK INC.
6.1.0
In Commercial Distribution

  • 00860011811961 ()


  • Alarm application software
Messenger 5.18.4 Software Release
SPOK INC.
5.18.4
In Commercial Distribution

  • 00860011811954 ()


  • Alarm application software
Messenger 5.17.17 Software Release
SPOK INC.
5.17.17
In Commercial Distribution

  • 00860011811947 ()


  • Alarm application software
Therapy cycling feedback software
ACCELERATED CARE PLUS CORP
OmniTourSoftware
In Commercial Distribution

  • 00858703006375 ()


  • Bioelectrical signal analysis software
Hearing Aid Fitting Software
INTRICON CORPORATION
hi-PS
In Commercial Distribution

  • 00858177007076 ()
22724

  • Hearing aid wireless-fitting computer-aided set
Kinesia StimPoint Application Software
Great Lakes Neurotechnologies Inc.
360-0050 Kinesia StimPoint Software
In Commercial Distribution

  • 00859584006195 ()
360-0050

  • Tremor transducer
Kinesia 360, Application Software
Great Lakes Neurotechnologies Inc.
360-0041, Application Software
In Commercial Distribution

  • 00859584006126 ()


  • Tremor transducer
Kinesia One, Application Software
Great Lakes Neurotechnologies Inc.
360-0040, Application Software
In Commercial Distribution

  • 00859584006119 ()


  • Tremor transducer
PACS Scan Software CD
HYLAND LLC
5
In Commercial Distribution

  • 00850677007112 ()


  • Radiography digital imaging scanner
PR Software OEM Embedded
Mindset Medical Inc.
PROEMEMB
In Commercial Distribution

  • 00850070776028 ()


  • Camera application software
ClearPoint - Software Version 3.0
Clearpoint Neuro, Inc.
CP-SFW-11-30
In Commercial Distribution

  • 00850047354099 ()
CP-SFW-11-30

  • Neurological stereotactic surgery system
ClearPoint - Software Version 2.0.1
Clearpoint Neuro, Inc.
CP-SFW-11-201
In Commercial Distribution

  • 00850359007751 ()
CP-SFW-11-201

  • Neurological stereotactic surgery system
ClearPoint Software Version 2.2
Clearpoint Neuro, Inc.
CP-SFW-11-22
In Commercial Distribution

  • 00850376007888 ()
CP-SFW-11-22

  • Neurological stereotactic surgery system
ClearPoint Software Version 2.1
Clearpoint Neuro, Inc.
CP-SFW-11-21
In Commercial Distribution

  • 00850376007703 ()
CP-SFW-11-21

  • Neurological stereotactic surgery system
ClearPoint - Software Version 2.0.2
Clearpoint Neuro, Inc.
CP-SFW-11-202
In Commercial Distribution

  • 00850359007768 ()
CP-SFW-11-202

  • Neurological stereotactic surgery system
ClearPoint - Software Version 1.6.2
Clearpoint Neuro, Inc.
CP-SFW-11-162
In Commercial Distribution

  • 00850359007614 ()
CP-SFW-11-162

  • Neurological stereotactic surgery system
ClearPoint - Software Version 2.0
Clearpoint Neuro, Inc.
CP-SFW-11-20
In Commercial Distribution

  • 00850359007607 ()
CP-SFW-11-20

  • Neurological stereotactic surgery system
ClearPoint - Software Version 2.0.3
Clearpoint Neuro, Inc.
CP-SFW-11-203
In Commercial Distribution

  • 00850359007003 ()
CP-SFW-11-203

  • Neurological stereotactic surgery system
DENTCA Design - DENTCA Software
DENTCA, INC.
DENTCA Design - Software
In Commercial Distribution

  • 00856551007506 ()


  • CAD/CAM software
SOFTWARE 8870AAV01 N'VISION US
MEDTRONIC, INC.
8870AAV01
In Commercial Distribution

  • 00643169955653 ()


  • Multiple active implantable device programmer
Imaging Software Upgrade Kit
LIGHTLAB IMAGING, INC.
1015209
In Commercial Distribution

  • 05415067048882 ()
1015209

  • Coronary optical coherence tomography system
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