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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 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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