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 Installation, 30 day trial, v.2.0.0
ST. JUDE MEDICAL, INC.
H702496-T
In Commercial Distribution

  • 05415067026118 ()
H702496-T

  • Cardiac mapping system application software
Dental imaging capture, enhance and display software.
APTERYX INC
3
In Commercial Distribution

  • 00685031000023 ()


  • General-purpose dental x-ray system application software
Dental imaging capture, enhance and display software.
APTERYX INC
3
Not in Commercial Distribution

  • 00685031000016 ()


  • General-purpose dental x-ray system application software
Dental imaging capture, enhance and display software.
APTERYX INC
4
Not in Commercial Distribution

  • 00685031000009 ()


  • General-purpose dental x-ray system application software
Abbott Diabetes Care USB Data Cable Software
ABBOTT DIABETES CARE INC
70851
Not in Commercial Distribution

  • 30699073000843 ()
  • 00699073000842 ()
  • 99073-0708-51 ()
70851

  • Electrical-only medical device connection cable, reusable
Abbott Diabetes Care USB Data Cable Software
ABBOTT DIABETES CARE INC
70851
In Commercial Distribution

  • 30699073708510 ()
  • 00699073708519 ()
  • 00699073000842 ()
70851

  • Electrical-only medical device connection cable, reusable
3CPM EGGSAS Research/Waterload Interface (Software Only)
3CPM CO., INC.
2.09g
In Commercial Distribution

  • 00864359000292 ()


  • Myoelectric gastrointestinal motility analysis system
Guideline™ 4000 5.0 Software, Version 2.2.0
FHC, INC.
C0217-00864
In Commercial Distribution

  • 00873263008645 ()
C0217

  • Neurophysiologic monitoring system
  • Electroencephalograph
microTargeting WayPoint Navigato, Laptop and Software, 1x
FHC, INC.
66-WP-NV(4.2)-00433
Not in Commercial Distribution

  • 00873263004333 ()
66-WP-NV(4.2)

  • Neurological stereotactic surgery system
ROMA (HE4 EIA + ARCHITECT CA125II) Software disk
Fujirebio Diagnostics, Inc.
404-10US
In Commercial Distribution

  • 00869164000024 ()


  • Laboratory instrument/analyser application software IVD
Aurora Xi Plasmapheresis System Software Version 1.2
Fresenius Kabi AG
1.2
In Commercial Distribution

  • 04086000101967 ()


  • Apheresis system
SFTWR KIT 9733933XOM DICOM SOFTWARE Q/R
MEDTRONIC NAVIGATION, INC.
9733933XOM
In Commercial Distribution

  • 00613994481115 ()


  • Multi-purpose stereotactic surgery system
SOFTWARE KIT 9733652XOM FUSION SW W/PG
MEDTRONIC NAVIGATION, INC.
9733652XOM
In Commercial Distribution

  • 00613994469199 ()


  • ENT stereotactic surgery system
SFTWR KIT 9733933 DICOM SOFTWARE Q/R
MEDTRONIC NAVIGATION, INC.
9733933
In Commercial Distribution

  • 00613994467072 ()


  • Multi-purpose stereotactic surgery system
IFU USB WADCS SPIRO V2.X SOFTWARE
WELCH ALLYN, INC.
901128
In Commercial Distribution

  • 00732094315516 ()
413258

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

  • 00732094315509 ()
413259

  • Electrocardiograph, professional, multichannel
Welch Allyn CardioPerfect Software Module for ABPM-6100
WELCH ALLYN, INC.
901047
In Commercial Distribution

  • 00732094097078 ()
ABP-SW

  • Ophthalmic/otologic diagnostic set
To support the 7.x software version
Philips Ultrasound LLC
795125
In Commercial Distribution

  • 00884838109971 ()


  • General-purpose ultrasound imaging system
SOFTWARE 9734472 SONONAV CAL APP FOR SC
MEDTRONIC NAVIGATION, INC.
9734472
In Commercial Distribution

  • 00643169183407 ()


  • Multi-purpose stereotactic surgery system
Leica Biosystems CytoVision Karyotype & FISH Software Update
Leica Biosystems Richmond, Inc.
23SWR002KFL001
Not in Commercial Distribution

  • 00849832003687 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica CytoVision Karyotyping review software (incl. dongle)
Leica Biosystems Richmond, Inc.
23SWR000KXX001
Not in Commercial Distribution

  • 00849832003656 ()

  • Device Size Text, specify:


  • Laboratory analyser operation system software IVD
Leica Biosystems CytoVision Karyotyping Software License Activation
Leica Biosystems Richmond, Inc.
23SWR000KLX001
Not in Commercial Distribution

  • 00849832003649 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision Karyotyping & FISH Review software
Leica Biosystems Richmond, Inc.
23SWR000KFX001
Not in Commercial Distribution

  • 00849832003632 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Licence, Software, LiDCOrapid (Rapid, CNAP, BIS, Ext)
LIDCO LIMITED
Li11076
In Commercial Distribution

  • 05060110522330 ()
Li11076

  • General-purpose multi-parameter bedside monitor
Digital stethoscope and hosted software application solution.
Globalmed Holdings, LLC
GSW30100103
In Commercial Distribution

  • 00850033167108 ()
GSW30100103

  • Stethoscope application software
Control software for the ATLAS Stim Headbox.
NEURALYNX, INC.
1.5.1
Not in Commercial Distribution

  • 00850011306703 ()
36-0301-0006

  • Somatosensory electrical stimulation system
Software for Nurse Station Console, Version 2.4.1
AMPLION CLINICAL COMMUNICATIONS, INC.
S-NSC-241-1
Not in Commercial Distribution

  • 00850016398772 ()
S-NSC-241-1

  • Nurse call system
Software for Code Blue Annunciator, Version 1.8.8
AMPLION CLINICAL COMMUNICATIONS, INC.
S-CBA-188-1
Not in Commercial Distribution

  • 00850016398758 ()
S-CBA-188-1

  • Nurse call system
Software for Smart Room Controller, Version 1.8.7
AMPLION CLINICAL COMMUNICATIONS, INC.
S-SRC-187-1
Not in Commercial Distribution

  • 00850016398390 ()
S-SRC-187-1

  • Nurse call system
Software for Nurse Station Console, Version 2.2.0.0
AMPLION CLINICAL COMMUNICATIONS, INC.
S-NSC-2200-1
Not in Commercial Distribution

  • 00850016398383 ()
S-NSC-2200-1

  • Nurse call system
Software for Code Blue Annunciator, Version 1.8.7
AMPLION CLINICAL COMMUNICATIONS, INC.
S-CBA-187-1
Not in Commercial Distribution

  • 00850016398345 ()
S-CBA-187-1

  • Nurse call system
SOFTWARE MMT-7310 SOLNS EA CGMS V3.0C EN
MEDTRONIC MINIMED, INC.
MMT-7310
In Commercial Distribution

  • 00613994675293 ()


  • Home healthcare information system
Software Kit FACSDiva 9.4 RUO w/Dongle
BECTON, DICKINSON AND COMPANY
664286
Not in Commercial Distribution

  • 00382906642868 ()
664286

  • Laboratory instrument/analyser application software IVD
Natus Elite - Synergy & Viking Combo Master Software
NATUS NEUROLOGY INCORPORATED
828-069500
In Commercial Distribution

  • 00382830035019 ()


  • Electromyograph
Natus Elite v2 Software - Synergy & Viking Combo
NATUS NEUROLOGY INCORPORATED
828-080300
In Commercial Distribution

  • 00382830062220 ()


  • Electromyograph
EMG Software Upgrade with New System Order
NATUS NEUROLOGY INCORPORATED
017806
In Commercial Distribution

  • 00382830061933 ()


  • Electromyograph
NeuroWorks TrexHD Monitoring Software Installation Media (US)
XLTEK
021764
In Commercial Distribution

  • 00382830043380 ()


  • Electroencephalograph
BD FACSCount System Users Guide and Software
Becton, Dickinson And Company
344619
In Commercial Distribution

  • 00382903446193 ()
344619

  • Laboratory instrument/analyser application software IVD
KOSMOS OTS iOS SOFTWARE PACKAGE [2.X]
ECHONOUS, INC.
P007944
In Commercial Distribution

  • 09353278000762 ()


  • Ultrasound imaging system application software
EchoNous (Uscan) Samsung S8 Tablet with Software
ECHONOUS, INC.
P007635
In Commercial Distribution

  • 09353278000663 ()


  • Hand-held ultrasound imaging system, body-surface
SOFTWARE KIT 9733652 FUSION SW WITH PG
MEDTRONIC NAVIGATION, INC.
9733652
In Commercial Distribution

  • 00613994378798 ()


  • ENT stereotactic surgery system
EncoreAnywhere Data Management Software (U.S. - North America)
Respironics, Inc.
2.35
In Commercial Distribution

  • 00606959047228 ()
1119756

  • Medical equipment clinical data interfacing software
EncoreAnywhere Data Management Software (North American Instance)
Respironics, Inc.
2.32
In Commercial Distribution

  • 00606959042902 ()
1119756

  • Medical equipment clinical data interfacing software
G5 Mobile Android App Stand Alone Software
Dexcom, Inc.
SW10940
In Commercial Distribution

  • 00386270000293 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
G5 Mobile IOS App Stand Alone Software
Dexcom, Inc.
SW10611
In Commercial Distribution

  • 00386270000002 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Encore Pro 2, Patient Management Software (DVD)
Respironics, Inc.
Encore Pro Patient Management Software - 2
In Commercial Distribution

  • 00606959053793 ()
1054785

  • Medical equipment clinical data interfacing software
Grael EEG v2 System with EEG software
COMPUMEDICS LIMITED
Grael EEG
In Commercial Distribution

  • 09342451001825 ()
9028-0004-02

  • Electroencephalograph
Task Force Monitor Software inkl. Kunden-CD (multilingual)
CNSystems Medizintechnik AG
V2.3
Not in Commercial Distribution

  • 09120073931009 ()


  • Noninvasive haemodynamic monitoring system
VA version of Baha Fitting Software 7
Cochlear Bone Anchored Solutions AB
V 7.0
In Commercial Distribution

  • 09321502075527 ()
P2121915

  • Hearing aid wireless-fitting computer-aided set
Speech Articulation: Animation of Muscle Vectors, Software
PENTAX OF AMERICA, INC.
5154
Not in Commercial Distribution

  • 04961333229857 ()


  • Electroglottograph
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