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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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EASYMAG SOFTWARE V2.1 : virtual reference
BIOMERIEUX SA
2.1
In Commercial Distribution

  • 03573026448301 ()


  • Nucleic acid sample preparation instrument IVD
ImageFusion 3 Software Install Kit
INTEGRA LIFESCIENCES CORPORATION
IF3000
Not in Commercial Distribution

  • M433IF30001 ()
  • 10381780252634 ()


  • Stereotactic radiosurgical invasive head frame
NeuroSight Arc Software on Laptop
INTEGRA LIFESCIENCES CORPORATION
ST1000
Not in Commercial Distribution

  • M433ST10001 ()
  • 10381780252627 ()
ST1000

  • Neurological stereotactic surgery system
Monarch™ Software Tower v2.1.2
AURIS HEALTH, INC.
Version 2.1.2
In Commercial Distribution

  • B634SW0032740201020 ()


  • Robotic surgical system application software
Monarch™ Software Laptop v2.1.5
AURIS HEALTH, INC.
Version 2.1.5
In Commercial Distribution

  • B634SW0032760201050 ()


  • CT system application software
Monarch™ Software Laptop v2.1.4
AURIS HEALTH, INC.
Version 2.1.4
In Commercial Distribution

  • B634SW0032760201040 ()


  • CT system application software
Monarch™ Software Laptop v2.1.3
AURIS HEALTH, INC.
Version 2.1.3
In Commercial Distribution

  • B634SW0032760201030 ()


  • CT system application software
Monarch™ Software Laptop v2.1.2
AURIS HEALTH, INC.
Version 2.1.2
In Commercial Distribution

  • B634SW0032760201020 ()


  • CT system application software
Monarch™ Software Cart v2.1.5
AURIS HEALTH, INC.
Version 2.1.5
In Commercial Distribution

  • B634SW0032750201050 ()


  • Robotic surgical system application software
Monarch™ Software Cart v2.1.4
AURIS HEALTH, INC.
Version 2.1.4
In Commercial Distribution

  • B634SW0032750201040 ()


  • Robotic surgical system application software
Monarch™ Software Cart v2.1.3
AURIS HEALTH, INC.
Version 2.1.3
In Commercial Distribution

  • B634SW0032750201030 ()


  • Robotic surgical system application software
Monarch™ Software Cart v2.1.2
AURIS HEALTH, INC.
Version 2.1.2
In Commercial Distribution

  • B634SW0032750201020 ()


  • Robotic surgical system application software
Monarch™ Software Tower v2.1.5
AURIS HEALTH, INC.
Version 2.1.5
In Commercial Distribution

  • B634SW0032740201050 ()


  • Robotic surgical system application software
Monarch™ Software Tower v2.1.4
AURIS HEALTH, INC.
Version 2.1.4
In Commercial Distribution

  • B634SW0032740201040 ()


  • Robotic surgical system application software
Monarch™ Software Tower v2.1.3
AURIS HEALTH, INC.
Version 2.1.3
In Commercial Distribution

  • B634SW0032740201030 ()


  • Robotic surgical system application software
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
DVD SOFTWARE XScribe CP v4.0.3
WELCH ALLYN, INC.
901144
Not in Commercial Distribution

  • 00817655021294 ()
420181

  • Electrocardiographic lead set, reusable
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
Synergy Matrix Core Software License
ARTHREX, INC.
AR-3200-1053
In Commercial Distribution

  • 00888867384866 ()
AR-3200-1053

  • Multidisciplinary medical image management software
Desktop PC with Zvu Software
DIVERSATEK HEALTHCARE, INC.
COMP-KIT
In Commercial Distribution

  • 00816734023488 ()
COMP-KIT

  • Manometric gastrointestinal motility analysis system
ZVU® Functional GI Software
DIVERSATEK HEALTHCARE, INC.
ZVU-3
In Commercial Distribution

  • 00816734022825 ()
ZVU-3

  • Manometric gastrointestinal motility analysis system
Bioview® Manometry Acquisition Software
DIVERSATEK HEALTHCARE, INC.
S98-1925-7P1
In Commercial Distribution

  • 00816734022139 ()
  • B019S9819257P10 ()
S98-1925-7P1

  • Manometric gastrointestinal motility analysis system
Bioview® Manometry Acquisition Software
DIVERSATEK HEALTHCARE, INC.
S98-1925-6P1
In Commercial Distribution

  • 00816734022122 ()
  • B019S9819256P10 ()
S98-1925-6P1

  • Manometric gastrointestinal motility analysis system
Bioview® Manometry Acquisition Software
DIVERSATEK HEALTHCARE, INC.
S98-1925-5P1
In Commercial Distribution

  • 00816734022115 ()
  • B019S9819255P10 ()
S98-1925-5P1

  • Manometric gastrointestinal motility analysis 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
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