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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 - 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

Smart Correction - B562C2C20210

Click2Correct/ Smart Correction software
Wishbone Medical, Inc.
C2C20210
Not in Commercial Distribution

  • B562C2C20210 ()


  • External orthopaedic fixation frame calculation software

DYONICS POWER - 03596010622716

DYONICS II SOFTWARE UPGRADE
Smith & Nephew, Inc.
72202103
In Commercial Distribution

  • 03596010622716 ()
72202103

  • Arthroscopic shaver system, electrically-powered

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

Arthrex® - 00888867339941

SYNERGY MATRIX SOFTWARE LICENSE
ARTHREX, INC.
AR-3200-1052
In Commercial Distribution

  • 00888867339941 ()
AR-3200-1052

  • Multidisciplinary medical image management software

iTero Lumina Pro - 00816063023067

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

  • 00816063023067 ()


  • CAD/CAM software

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
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