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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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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 2.0.3
Clearpoint Neuro, Inc.
CP-SFW-11-203
In Commercial Distribution

  • 00850359007003 ()
CP-SFW-11-203

  • Neurological stereotactic surgery system
PR Software OEM Embedded
Mindset Medical Inc.
PROEMEMB
In Commercial Distribution

  • 00850070776028 ()


  • Camera application software
Specialized user interface software
INTERSON CORP
x.x
In Commercial Distribution

  • 00850921007196 ()


  • General-purpose ultrasound imaging system
Specialized user interface software
INTERSON CORP
x.x
In Commercial Distribution

  • 00850921007189 ()


  • General-purpose ultrasound imaging system
PACS Scan Software CD
HYLAND LLC
5
In Commercial Distribution

  • 00850677007112 ()


  • Radiography digital imaging scanner
Dental Cloud Imaging Software
SOTA PRECISION OPTICS, INC.
1
In Commercial Distribution

  • 00851159007125 ()


  • General-purpose dental x-ray system application software
Sleep Profiler Portal Software
ADVANCED BRAIN MONITORING, INC.
Sleep Profiler Portal Software
In Commercial Distribution

  • 00851113007024 ()


  • Polysomnography analyser
Sleep Profiler Desktop Software
ADVANCED BRAIN MONITORING, INC.
Sleep Profiler Desktop Software
In Commercial Distribution

  • 00851113007017 ()


  • Polysomnography analyser
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
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
Genie Medical fitting software
Oticon Medical AB
M50504
In Commercial Distribution

  • 05712149000777 ()
M50504

  • Audiometric/hearing device 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
ORTHOPILOT SOFTWARE TKA VEGA
Aesculap AG
FS226
Not in Commercial Distribution

  • 04046963895853 ()
FS226

  • Robotic surgical navigation system application software
ORTHOPILOT SOFTWARE COLUMBUS TKR
Aesculap AG
FS222
Not in Commercial Distribution

  • 04046963492083 ()
FS222

  • Robotic surgical navigation system application software
ORTHOPILOT SOFTWARE THA ACA
Aesculap AG
FS229
Not in Commercial Distribution

  • 04046963989101 ()
FS229

  • Robotic surgical navigation system application software
ORTHOPILOT SOFTWARE TKA SMART
Aesculap AG
FS228
Not in Commercial Distribution

  • 04046963977979 ()
FS228

  • Robotic surgical navigation system application software
VITAL SYNC V2 SOFTWARE
Covidien LP
VITALSYNCSW01
In Commercial Distribution

  • 10884521795273 ()


  • Multiparameter physiologic analysis workstation
VITAL SYNC V2 SOFTWARE
Covidien LP
VITALSYNCSW01
In Commercial Distribution

  • 10884521780668 ()


  • Multiparameter physiologic analysis workstation
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