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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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Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800014
In Commercial Distribution

  • 05415067042385 ()
H800014

  • Cardiac catheterization monitoring system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800013
In Commercial Distribution

  • 05415067042378 ()
H800013

  • Cardiac catheterization monitoring system
Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800015
In Commercial Distribution

  • 05415067042361 ()
H800015

  • Cardiac catheterization monitoring system
3D Echo Software
JOINTVUE, LLC
1.0
Not in Commercial Distribution

  • 00850014885007 ()


  • Ultrasound imaging system operation software
Programmer and Software
LIVANOVA USA, INC.
3100
In Commercial Distribution

  • 05425025750634 ()


  • Vagus nerve electrical stimulation system programmer
Dental CAD Software
3shape A/S
2017-1 (R1.1)
In Commercial Distribution

  • 05902729752237 ()


  • CAD/CAM software
Dental CAD Software
3shape A/S
R1.1
In Commercial Distribution

  • 05902729752220 ()


  • CAD/CAM software
NBT main software
NEXSTIM, INC.
2
In Commercial Distribution

  • 06430063200156 ()


  • Stereotactic neuronavigation/planning system
NexSpeech Analyzer Software
NEXSTIM, INC.
2
In Commercial Distribution

  • 06430063200033 ()


  • Stereotactic neuronavigation/planning system
  • Hand-held deep-tissue electromagnetic stimulator
  • Electromyograph
NexSpeech Main Software
NEXSTIM, INC.
2
In Commercial Distribution

  • 06430063200026 ()


  • Stereotactic neuronavigation/planning system
  • Hand-held deep-tissue electromagnetic stimulator
  • Electromyograph
NBS main software
NEXSTIM, INC.
5
In Commercial Distribution

  • 06430063200002 ()


  • Hand-held deep-tissue electromagnetic stimulator
  • Electromyograph
  • Stereotactic neuronavigation/planning system
Richmar EMG Software
COMPASS HEALTH BRANDS CORP.
EMG-SW
In Commercial Distribution

  • 00092237626573 ()


  • Electromyograph
Remote Monitoring Software
MICROPORT CRM SRL
RMS
In Commercial Distribution

  • 08031527021188 ()
RMS

  • Cardiology information system application software
Vascular documentation software
KOVEN TECHNOLOGY, INC.
Smart-V-Link
In Commercial Distribution

  • 00894912002777 ()
Smart-V-Link

  • Ultrasound imaging system application software
Modality Worklist Software
KOVEN TECHNOLOGY, INC.
2.0
In Commercial Distribution

  • 00894912002067 ()
PAUS2.0

  • Radiology information system application software
StereoCalc 2.0 Software
INTEGRA LIFESCIENCES CORPORATION
SCSWCD
Not in Commercial Distribution

  • M248SCSWCD1 ()
  • 10381780252610 ()
SC SW CD

  • Neurological stereotactic surgery system
FastMap Photogrammetry Software
XNAV TECHNOLOGIES LLC
P011942
In Commercial Distribution

  • 00817421022852 ()


  • Dental milling system, CAD/CAM, laboratory
Dental imaging software
CYBER MEDICAL IMAGING, INC.
Imaging Software
In Commercial Distribution

  • D787XDRSW300 ()
XDRSW30

  • General-purpose dental x-ray system application software
Dental imaging software
CYBER MEDICAL IMAGING, INC.
Imaging Software
In Commercial Distribution

  • D787XDRSW1 ()
XDRSW

  • General-purpose dental x-ray system application software
SC+ AI Software
STRYKER CORPORATION
0894000004
In Commercial Distribution

  • 07613327622782 ()
0894-000-004

  • Blood loss estimation application software
+ Sponge Counting Software
STRYKER CORPORATION
0894000003
In Commercial Distribution

  • 07613327622751 ()
0894-000-003

  • Electronic surgical sponge-counter
QBL Software License
STRYKER CORPORATION
0794111090
In Commercial Distribution

  • 07613327568998 ()
0794-111-090

  • Electronic surgical sponge-counter
Spine Guidance Software
Stryker Leibinger GmbH & Co. KG
6002-710-000
In Commercial Distribution

  • 07613327545883 ()
6002-710-000

  • Surgical planning/navigation-enhancement system
Cranial Guidance Software
Stryker Leibinger GmbH & Co. KG
6000-670-000
In Commercial Distribution

  • 07613327538298 ()
6000-670-000

  • Electromagnetic/optical surgical navigation device tracking system
CuattroDR System Software
Cuattro Medical
SWR-00069-MD
In Commercial Distribution

  • B269SWR00069MD0 ()


  • Stationary basic diagnostic x-ray system, digital
Synergy.net Management Software
ARTHREX, INC.
AR-3200-1030
In Commercial Distribution

  • 00888867100626 ()
AR-3200-1030

  • Operating room audiovisual data/device management system
Central Server Software
Lifesignals, Inc.
UA2550-S
In Commercial Distribution

  • B353UA2550S1 ()


  • Network server
Relay Bridge Software
Lifesignals, Inc.
UA2550-RB
In Commercial Distribution

  • B353UA2550RB1 ()


  • Physiological measuring device wireless data capture/transfer unit
Bluetooth Gateway Software
Lifesignals, Inc.
UA2550-BG
In Commercial Distribution

  • B353UA2550BG1 ()


  • Physiological measuring device wireless data capture/transfer unit
Clinician Programmer Software
BIONESS INC.
ST2-SW01
In Commercial Distribution

  • 00815962020306 ()


  • Transcutaneous electrical stimulation probe
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