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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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IH-Com V5.0, Software Version 5.0.10
Bio-Rad Medical Diagnostics GmbH
5.0.10
In Commercial Distribution

  • 07611969234417 ()
009101

  • Laboratory instrument/analyser application software IVD
FLUOROSCOPY SOFTWARE 2.3 CD-SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-80037
In Commercial Distribution

  • 07613154481118 ()
81-80037

  • Robotic surgical navigation system application software
ADAPT 2.0 for Gamma3 Software
Stryker GmbH
0101-0001
In Commercial Distribution

  • 07613327311822 ()
0101-0001

  • Medical image management system
Hscribe Web Upload software kit
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00817655020952 ()
88188-001-50

  • Centralized patient monitor
QTEL v5.0.1 eSIGNATURE SOFTWARE CD
WELCH ALLYN, INC.
901145
In Commercial Distribution

  • 00817655023106 ()
419734

  • Centralized patient monitor
Software for analysis of echocardiogram
EPSILON IMAGING
3.2.0
Not in Commercial Distribution

  • B557ECHOINSIGHT0 ()


  • Cardiac mapping system application software
Oximeter Sleep Study without Software
MAXTEC, LLC
R204P18-001
Not in Commercial Distribution

  • 00817770020547 ()


  • Pulse oximeter
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
Software, Delivery Analysis, Version 1.2.2
ACCURAY INCORPORATED
1064315
In Commercial Distribution

  • M65810643150 ()
NA

  • Linear accelerator system
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