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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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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
X-Guide 2.3.6 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421020971 ()


  • Surgical planning/navigation-enhancement system
X-Guide 2.3.5 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421020964 ()


  • Surgical planning/navigation-enhancement system
X-Guide 2.3.2 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421020896 ()


  • Surgical planning/navigation-enhancement system
Spine Guidance 5 Software
Stryker Leibinger GmbH & Co. KG
6002-810-000
In Commercial Distribution

  • 07613327616118 ()
6002-810-000

  • Optical surgical navigation device tracking system
ENT Software with TGS
Stryker Leibinger GmbH & Co. KG
8000-021-002
In Commercial Distribution

  • 07613327514179 ()
8000-021-002

  • Stereotactic system application software
iTero Lumina Pro Software
Align Technology, Inc.
225979
In Commercial Distribution

  • 00816063023067 ()


  • CAD/CAM software
Synergy Matrix Management Software
ARTHREX, INC.
AR-3200-1036
In Commercial Distribution

  • 00888867253902 ()
AR-3200-1036

  • Operating room audiovisual data/device management system
Aura:fit Software v 5.0
Unitron Hearing Division
058-5260
In Commercial Distribution

  • 07613389483895 ()
058-5260

  • Audiometric/hearing device software
TrueFit Software v 5.0
Unitron Hearing Division
058-5259
In Commercial Distribution

  • 07613389483888 ()
058-5259

  • Audiometric/hearing device software
SYNERGY MATRIX SOFTWARE LICENSE
ARTHREX, INC.
AR-3200-1052
In Commercial Distribution

  • 00888867339941 ()
AR-3200-1052

  • Multidisciplinary medical image management software
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