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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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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
SOFTWARE 9734472 SONONAV CAL APP FOR SC
MEDTRONIC NAVIGATION, INC.
9734472
In Commercial Distribution

  • 00643169183407 ()


  • Multi-purpose stereotactic surgery system
Speech Articulation: Animation of Muscle Vectors, Software
PENTAX OF AMERICA, INC.
5154
Not in Commercial Distribution

  • 04961333229857 ()


  • Electroglottograph
Grael EEG v2 System with EEG software
COMPUMEDICS LIMITED
Grael EEG
In Commercial Distribution

  • 09342451001825 ()
9028-0004-02

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

  • 09120073931009 ()


  • Noninvasive haemodynamic monitoring system
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
EncoreAnywhere Data Management Software (North American Instance)
Respironics, Inc.
2.32
In Commercial Distribution

  • 00606959042902 ()
1119756

  • Medical equipment clinical data interfacing software
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
EncoreAnywhere Data Management Software (U.S. - North America)
Respironics, Inc.
2.35
In Commercial Distribution

  • 00606959047228 ()
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
SOFTWARE MMT-7310 SOLNS EA CGMS V3.0C EN
MEDTRONIC MINIMED, INC.
MMT-7310
In Commercial Distribution

  • 00613994675293 ()


  • Home healthcare information system
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
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
3CPM EGGSAS Research/Waterload Interface (Software Only)
3CPM CO., INC.
2.09g
In Commercial Distribution

  • 00864359000292 ()


  • Myoelectric gastrointestinal motility analysis system
Aurora Xi Plasmapheresis System Software Version 1.2
Fresenius Kabi AG
1.2
In Commercial Distribution

  • 04086000101967 ()


  • Apheresis system
SOFTWARE KIT,VMAX ENCORE VERSION 20-5B CD
Carefusion Corporation
63654
Not in Commercial Distribution

  • 10846446027600 ()
63654

  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult
Abbott Diabetes Care USB Data Cable Software
ABBOTT DIABETES CARE INC
70845
In Commercial Distribution

  • 30093815708453 ()
  • 00093815708452 ()
  • 00093815000839 ()
70845

  • Electrical-only medical device connection cable, reusable
Abbott Diabetes Care USB Data Cable Software
ABBOTT DIABETES CARE INC
70845
Not in Commercial Distribution

  • 30093815000830 ()
  • 00093815000839 ()
  • 57599-0845-1 ()
70845

  • Electrical-only medical device connection cable, reusable
Resting ECG connectivity gateway software v.5.0.0
WELCH ALLYN, INC.
901147
Not in Commercial Distribution

  • 00817655021058 ()
11027-024-50

  • Electrocardiograph, professional, multichannel
USB Stick containing Mag Log Converter Software
Thoratec Switzerland GmbH
201-52213
In Commercial Distribution

  • 07640135140566 ()
201-52213

  • Circulatory assist system application software
GoCheck Kids Native Software Application for Nokia.
Gobiquity, Inc.
Nokia 4.6.3
In Commercial Distribution

GCKNOK463

  • External ocular measurement camera
Zvu® Functional GI Software Revision 3.4.0
DIVERSATEK HEALTHCARE, INC.
ZVU-3 Revision 3.4.0
In Commercial Distribution

  • 00816734023426 ()
ZVU-3

  • Manometric gastrointestinal motility analysis system
Clinician Programmer Software for L300 Go system
BIONESS INC.
LG4-SW01
In Commercial Distribution

  • 00815962020061 ()


  • Gait-enhancement electrical stimulation system, external
Esteem® Commander™ Software Version 3.0
Envoy Medical Corporation
6002
In Commercial Distribution

  • 00812282020504 ()
006002-002

  • Fully-implantable middle ear implant system
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