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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 9735462 DICOM LICENSE ENT
MEDTRONIC NAVIGATION, INC.
9735462
In Commercial Distribution

  • 00643169491960 ()


  • Multi-purpose stereotactic surgery system
SOFTWARE 9733686 S7 SYNERGY SPINE
MEDTRONIC NAVIGATION, INC.
9733686
In Commercial Distribution

  • 00643169480957 ()


  • Multi-purpose stereotactic surgery system
Actiware, Software CD, US Gov.
Respironics, Inc.
Actiware, Software CD, US Gov. - 6
In Commercial Distribution

  • 00606959057753 ()
1143911

  • Kinesiology ambulatory recorder
Sleepware G3 Software Package, English
Respironics, Inc.
3.8
In Commercial Distribution

  • 00606959004849 ()
1082462

  • Polysomnography analyser
Software, HL7 Sleepware G3, Web
Respironics, Inc.
Software, HL7 Sleepware G3, Web - 3
In Commercial Distribution

  • 00606959048942 ()
1117948

  • Clinical laboratory information system
Software, Sleepware G3 (Japan Only)
Respironics, Inc.
Sleepware G3 Software, (Japan Only) - 3
Not in Commercial Distribution

  • 00606959046955 ()
1121998

  • Polysomnography analyser
Software, Sleepware G3, Web download
Respironics, Inc.
Sleepware G3 Software, Web download - 3
In Commercial Distribution

  • 00606959045279 ()
1115720

  • Polysomnography analyser
Actiware Clinical Trial Software, English
Respironics, Inc.
Actiware Clinical Trial Software, English - 6
In Commercial Distribution

  • 00606959040366 ()
1103609

  • Kinesiology ambulatory recorder
Sleepware G3 Software Package, Japan
Respironics, Inc.
3.8
In Commercial Distribution

  • 00606959038943 ()
1121998

  • Polysomnography analyser
TS1200CL TELESTETH SOFTWARE HOSTED LICENSE
3M COMPANY
TS1200CL
In Commercial Distribution

  • 00707387766597 ()
TS1200CL

  • Stethoscope application software
Nexstim NBS German Main Software
Nexstim Oyj
5
In Commercial Distribution

  • 06430063200064 ()


  • Stereotactic neuronavigation/planning system
  • Hand-held deep-tissue electromagnetic stimulator
  • Electromyograph
MR-RT RTgo software USB stick
Philips Oy
989603083082
In Commercial Distribution

  • 00884838084667 ()


  • MRI system application software
MR-RT RTgo software USB stick
Philips Oy
459801266633
In Commercial Distribution

  • 00884838092112 ()


  • MRI system application software
SOFTWARE 9730877 ORTHO LICENSE (PLUS)
MEDTRONIC NAVIGATION, INC.
9730877
Not in Commercial Distribution

  • 00721902849787 ()


  • Multi-purpose stereotactic surgery system
SOFTWARE EXECUTABLE, LUCAS Report Generator
PHYSIO-CONTROL, INC.
60600
In Commercial Distribution

  • 00883873851913 ()
60600-000145

  • Medical equipment clinical data interfacing software
STarFix™ Designer Software, Version
FHC, INC.
C0265-00860
In Commercial Distribution

  • 00873263008607 ()
C0265

  • Stereotactic neuronavigation/planning system
dental implant surgical guide software
GuidePro3D
1.0
In Commercial Distribution

  • 00864551000304 ()


  • Dental treatment application software
TAGCONNECT SOFTWARE AND SMART CABLE
WELCH ALLYN, INC.
901099
In Commercial Distribution

  • 00732094212464 ()
TAGECG-SW

  • Electrocardiographic ambulatory recorder
CONNEX CS SOFTWARE DELIVERY PHANTOM
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094250879 ()
411066

  • Centralized patient monitor
WADCS ECG SOFTWARE V2.X
WELCH ALLYN, INC.
901128
In Commercial Distribution

  • 00732094315493 ()
729324

  • Electrocardiograph, professional, multichannel
WADCS SPIRO SOFTWARE V2.X
WELCH ALLYN, INC.
901128
In Commercial Distribution

  • 00732094315486 ()
729325

  • Electrocardiograph, professional, multichannel
WADCS MANAGER SOFTWARE V2.X
WELCH ALLYN, INC.
901128
In Commercial Distribution

  • 00732094315479 ()
729326

  • Electrocardiograph, professional, multichannel
Q-TEL V5.0.1 Q-PROGRESS SOFTWARE CD
WELCH ALLYN, INC.
901145
In Commercial Distribution

  • 00732094307375 ()
419733

  • Centralized patient monitor
Q-TEL V5.0.1 Workstation Software CD
WELCH ALLYN, INC.
901145
In Commercial Distribution

  • 00732094307368 ()
413379

  • Centralized patient monitor
QTEL v5.0.1 TOWER SOFTWARE CD
WELCH ALLYN, INC.
901145
In Commercial Distribution

  • 00732094307351 ()
419751

  • Centralized patient monitor
ELI LINK V4.5.1 SOFTWARE DVD
WELCH ALLYN, INC.
901147
In Commercial Distribution

  • 00732094300710 ()
413225

  • Electrocardiograph, professional, multichannel
SOFTWARE MONITIOR WAVEFORM VIEWER V2.1.0
WELCH ALLYN, INC.
901012
In Commercial Distribution

  • 00732094296341 ()
11093-003-50

  • Cardiology information system application software
SOFTWARE ARRHYTHMIA ST LIBRARY v6.0.3
WELCH ALLYN, INC.
901008
In Commercial Distribution

  • 00732094272345 ()
11091-002-50

  • Centralized patient monitor
DVD SOFTWARE RScribe Lite v1.0.2
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094325300 ()
419614

  • Electrocardiograph, professional, multichannel
SOFTWARE SURVYOR CENTRAL REPEATER DVD
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094319903 ()
419832

  • Centralized patient monitor
Exact Sciences Software System 2.2
EXACT SCIENCES CORPORATION
2.2
In Commercial Distribution

  • 00858637005871 ()


  • Laboratory instrument/analyser application software IVD
Exact Sciences Software System 2.2
EXACT SCIENCES CORPORATION
2.2
In Commercial Distribution

  • 00858637005864 ()


  • Laboratory instrument/analyser application software IVD
Exact Sciences Software System 2.2
EXACT SCIENCES CORPORATION
2.2
In Commercial Distribution

  • 00858637005857 ()


  • Laboratory instrument/analyser application software IVD
Exact Sciences Software System 2.2
EXACT SCIENCES CORPORATION
2.2
In Commercial Distribution

  • 00858637005840 ()


  • Laboratory instrument/analyser application software IVD
Chromosome Analysis Suite Dx Software
Affymetrix, Inc.
2.1
In Commercial Distribution

  • 00856826006210 ()
610525

  • Human genomic analysis interpretive software
Chromosome Analysis Suite Dx Software
Affymetrix, Inc.
1.2
In Commercial Distribution

  • 00856826006074 ()
610525

  • Human genomic analysis interpretive software
Upload and transmission software application
PREVENTICE TECHNOLOGIES, INC.
SW1004
In Commercial Distribution

  • 00852132007316 ()


  • Cardiopulmonary physiological parameter analysis software
ClearPoint Array Software Version 1.0
Clearpoint Neuro, Inc.
CPA-SFW-11-1
In Commercial Distribution

  • 00850359007744 ()
CPA-SFW-11-1

  • Neurological stereotactic surgery system
Visix 8.1 software Build 81
TELEVERE SYSTEMS, LLC
8.1 Build 81
In Commercial Distribution

  • 00851800007054 ()
Visix 8.1 Build 81

  • Radiological PACS software
  • General-purpose dental x-ray system application software
  • Camera application software
  • Basic diagnostic x-ray system application software
Visix Pro software version 7.7.15
TELEVERE SYSTEMS, LLC
7.7.15
In Commercial Distribution

  • 00851800007047 ()
Visix Pro 7.7.15

  • Basic diagnostic x-ray system application software
  • Camera application software
  • General-purpose dental x-ray system application software
  • Radiological PACS software
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