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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 3.1.1 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
Medical Device Software Application
Airstrip Technologies, Inc.
2003
In Commercial Distribution

  • B15320030 ()


  • Bedside monitor remote-viewing software, physiological parameter
Bioness Integrated Therapy Software
BIONESS INC.
2.0.5
In Commercial Distribution

  • 00815962020245 ()


  • Perceptual-coordination assistive training device
Clinician’s Programmer with Software
BIONESS INC.
ST2-4000
In Commercial Distribution

  • 00815962020023 ()


  • Analgesic PENS system probe, single-use
iTero Lumina Pro Software
Align Technology, Inc.
225979
In Commercial Distribution

  • 00816063023067 ()


  • CAD/CAM software
Multi Patient Relay Software
Lifesignals, Inc.
UA2550-MR
In Commercial Distribution

  • B353UA2550MR1 ()


  • Physiological measuring device wireless data capture/transfer unit
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