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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 - 00817421022753

X-Guide 3.5.0 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022753 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022609

X-Guide 3.4.2 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022609 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022593

X-Guide 3.4.1 Windows Software
XNAV TECHNOLOGIES LLC
P008296
In Commercial Distribution

  • 00817421022593 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022418

X-Guide 3.4.0 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022418 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022296

X-Guide 3.3.4 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022296 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022067

X-Guide 3.3.2 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022067 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022012

X-Guide 3.3.1 Windows Software
XNAV TECHNOLOGIES LLC
P008296
In Commercial Distribution

  • 00817421022012 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421021909

X-Guide 3.3.0 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421021909 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421021893

X-Guide 3.1.1 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421021893 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421021183

X-Guide 3.1.0 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421021183 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020971

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

  • 00817421020971 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020964

X-Guide 2.3.5 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421020964 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020896

X-Guide 2.3.2 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421020896 ()


  • Surgical planning/navigation-enhancement system

AirStrip ONE Web Client - B15320030

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

  • B15320030 ()


  • Bedside monitor remote-viewing software, physiological parameter

Bioness Integrated System (BITS)2.0.5 - 00815962020245

Bioness Integrated Therapy Software
BIONESS INC.
2.0.5
In Commercial Distribution

  • 00815962020245 ()


  • Perceptual-coordination assistive training device

StimRouter Clinician's Kit - 00815962020023

Clinician’s Programmer with Software
BIONESS INC.
ST2-4000
In Commercial Distribution

  • 00815962020023 ()


  • Analgesic PENS system probe, single-use

iTero Lumina Pro - 00816063023067

iTero Lumina Pro Software
Align Technology, Inc.
225979
In Commercial Distribution

  • 00816063023067 ()


  • CAD/CAM software

UbiqVue - B353UA2550MR1

Multi Patient Relay Software
Lifesignals, Inc.
UA2550-MR
In Commercial Distribution

  • B353UA2550MR1 ()


  • Physiological measuring device wireless data capture/transfer unit

UbiqVue - B353UA2251W1

Holter Web Server Software
Lifesignals, Inc.
UA2251-W
In Commercial Distribution

  • B353UA2251W1 ()


  • Network server

UbiqVue - B353UA2251S1

Holter Central Server Software
Lifesignals, Inc.
UA2251-S
In Commercial Distribution

  • B353UA2251S1 ()


  • Network server
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