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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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2.0 Software Upgrade Kit
LIGHTLAB IMAGING, INC.
1015310
In Commercial Distribution

  • 05415067047694 ()
1015310

  • Coronary optical coherence tomography system
Software Upgrade, 10 Licenses
ST. JUDE MEDICAL, INC.
H800020
In Commercial Distribution

  • 05415067047229 ()
H800020

  • Cardiac catheterization monitoring system
Module Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800018
In Commercial Distribution

  • 05415067047205 ()
H800018

  • Cardiac catheterization monitoring system
Software Upgrade Site License
ST. JUDE MEDICAL, INC.
H800021
In Commercial Distribution

  • 05415067047199 ()
H800021

  • Cardiac catheterization monitoring system
Z620 Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800016
In Commercial Distribution

  • 05415067047182 ()
H800016

  • Cardiac catheterization monitoring system
Z440 Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800017
In Commercial Distribution

  • 05415067047175 ()
H800017

  • Cardiac catheterization monitoring system
EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-2.0
In Commercial Distribution

  • 05415067042460 ()
ENSITE-SW-2.0

  • Cardiac mapping system application software
Sleep Profiler RTA Software
ADVANCED BRAIN MONITORING, INC.
SP42-5402
In Commercial Distribution

  • 00850015266706 ()


  • Polysomnography analyser
Dental treatment application software
3shape Medical A/S
2017-1
Not in Commercial Distribution

  • 05902729750455 ()


  • Dental treatment application software
Dental treatment application software
3shape Medical A/S
2017-1
Not in Commercial Distribution

  • 05902729750448 ()


  • Dental treatment application software
Biofeedback device with software
QX WORLD LTD
NA
In Commercial Distribution

  • 05999860882015 ()


  • Biofeedback system application software
Dental treatment application software
3shape Medical A/S
2.17.3 (R1.2)
Not in Commercial Distribution

  • 05902729753265 ()


  • Dental treatment application software
Centralized Configuration Manager Software
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
000GCCM
In Commercial Distribution

  • 10711234540121 ()
000GCCM

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
FreeStyle Libre Pro Software
ABBOTT DIABETES CARE INC
75170
In Commercial Distribution

  • 30093815751701 ()
  • 00093815751700 ()
75170

  • Home healthcare information system application software
Vitek 2 software V10
BIOMERIEUX , INC.
10.0
In Commercial Distribution

  • 03573026618285 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
VIDAS 3 V1.4 Software
BIOMERIEUX SA
1.4
In Commercial Distribution

  • 03573026617622 ()


  • Fluorescent immunoassay analyser IVD, laboratory
X-Guide 3.6.0 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022838 ()


  • Surgical planning/navigation-enhancement system
X-Guide 3.5.8 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022821 ()


  • Surgical planning/navigation-enhancement system
X-Guide 3.5.4 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022814 ()


  • Surgical planning/navigation-enhancement system
X-Guide 3.5.2 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022784 ()


  • Surgical planning/navigation-enhancement system
X-Guide 3.5.0 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022753 ()


  • Surgical planning/navigation-enhancement system
X-Guide 3.4.2 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022609 ()


  • Surgical planning/navigation-enhancement system
X-Guide 3.4.1 Windows Software
XNAV TECHNOLOGIES LLC
P008296
In Commercial Distribution

  • 00817421022593 ()


  • Surgical planning/navigation-enhancement system
X-Guide 3.4.0 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022418 ()


  • Surgical planning/navigation-enhancement system
X-Guide 3.3.4 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022296 ()


  • Surgical planning/navigation-enhancement system
X-Guide 3.3.2 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022067 ()


  • Surgical planning/navigation-enhancement system
X-Guide 3.3.1 Windows Software
XNAV TECHNOLOGIES LLC
P008296
In Commercial Distribution

  • 00817421022012 ()


  • Surgical planning/navigation-enhancement system
X-Guide 3.3.0 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421021909 ()


  • Surgical planning/navigation-enhancement system
X-Guide 3.1.1 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421021893 ()


  • Surgical planning/navigation-enhancement system
X-Guide 3.1.0 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421021183 ()


  • Surgical planning/navigation-enhancement system
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