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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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ADAPT 2.0 for Gamma3 Software
Stryker GmbH
0101-0001
In Commercial Distribution

  • 07613327311822 ()
0101-0001

  • Medical image management system
X-Guide 3.6.0 Linux Software (MDR)
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022920 ()


  • Surgical planning/navigation-enhancement system
X-Guide Windows Planning Software 2.3.3
XNAV TECHNOLOGIES LLC
P008296
In Commercial Distribution

  • 00817421020803 ()
P008296

  • Dental treatment application software
X-Guide System Software Version 2.3.0
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421020797 ()
P008542

  • Surgical planning/navigation-enhancement system
X-GUIDE PLANNING SOFTWARE - MAC OS
XNAV TECHNOLOGIES LLC
P008526
In Commercial Distribution

  • 00817421020018 ()
P008526

  • Surgical planning/navigation-enhancement system
X-GUIDE PLANNING SOFTWARE - MS WINDOWS
XNAV TECHNOLOGIES LLC
P008296
In Commercial Distribution

  • 00817421020001 ()
P008296

  • Surgical planning/navigation-enhancement system
QTEL v5.0.1 eSIGNATURE SOFTWARE CD
WELCH ALLYN, INC.
901145
In Commercial Distribution

  • 00817655023106 ()
419734

  • Centralized patient monitor
RIS SOFTWARE < 25K EXAMS / YEAR
CARESTREAM HEALTH, INC.
Vue RIS
In Commercial Distribution

  • 60889978671366 ()
8671364

  • Radiology information system application software
Lumax™ Software Update pack
Coopersurgical, Inc.
53361
In Commercial Distribution

  • 60888937013445 ()


  • Urodynamic measurement system
PROFESS(TM) SOFTWARE SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-81033
In Commercial Distribution

  • 07613327071955 ()
81-81033

  • Robotic surgical navigation system application software
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