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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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Oximeter Sleep Study without Software
MAXTEC, LLC
R204P18-001
Not in Commercial Distribution

  • 00817770020547 ()


  • Pulse oximeter
QTEL v5.0.1 eSIGNATURE SOFTWARE CD
WELCH ALLYN, INC.
901145
In Commercial Distribution

  • 00817655023106 ()
419734

  • Centralized patient monitor
Hscribe Web Upload software kit
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00817655020952 ()
88188-001-50

  • Centralized patient monitor
IH-Com V5.2, Software Version 5.2
Bio-Rad Medical Diagnostics GmbH
5.2
In Commercial Distribution

  • 03610522123919 ()
12010236

  • Laboratory instrument/analyser application software IVD
Bidirectional Doppler with Smart-XT-Link6 software
KOVEN TECHNOLOGY, INC.
Smartdop XT6
In Commercial Distribution

  • 00894912002968 ()
Smartdop XT6

  • Noninvasive vascular ultrasound system, line-powered
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
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