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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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Cardiostation Software sold with wireless devices.
UNIVERSAL MEDICAL, INC.
Cardiostation Standalone Software
In Commercial Distribution

  • B147CSS0 ()


  • Electrocardiography telemetric monitoring system
Cardiostation Software sold with TTM module.
UNIVERSAL MEDICAL, INC.
Cardiostation® Advantage Software
In Commercial Distribution

  • B147CA0 ()


  • Electrocardiography telemetric monitoring system
TrueFit v3.7 DVD Software Package USA
Unitron Hearing Division
058-5229
In Commercial Distribution

  • 07613389221589 ()
058-5229

  • Audiometric/hearing device software
TrueFit Fitting Software v3.7 USB USA
Unitron Hearing Division
058-5228
In Commercial Distribution

  • 07613389221572 ()
058-5228

  • Audiometric/hearing device software
USB V3.6.1 Fitting Software Hansaton Scout
Hansaton Akustik GmbH
058-5227
In Commercial Distribution

  • 07613389143232 ()
058-5227

  • Audiometric/hearing device software
DVD v3.6.1 Fitting Software Hansaton Scout
Hansaton Akustik GmbH
058-5226
In Commercial Distribution

  • 07613389143225 ()
058-5226

  • Audiometric/hearing device software
IMAGE PROCESSING SOFTWARE / FOR VITA CR
CARESTREAM HEALTH, INC.
Vita CR System
In Commercial Distribution

  • 60889971919878 ()
1919877

  • Computed radiography digital imaging scanner
Zvu® Advanced GI Diagnostic Software
DIVERSATEK HEALTHCARE, INC.
ZVU-2016
In Commercial Distribution

  • 00816734022429 ()
  • B019ZVU20160 ()
ZVU-2016

  • Manometric gastrointestinal motility analysis system
Clinical Laboratory Information System application software
ASPYRA, LLC
7.3.1
In Commercial Distribution

  • B433CL0 ()
CL731

  • Clinical laboratory information system application software
360CAS KNEE NAVIGATION SYSTEM SOFTWARE v3
KICO KNEE INNOVATION COMPANY PTY LIMITED
3.1.1
In Commercial Distribution

  • B432360CAS3110 ()


  • Robotic surgical navigation system application software
Stand-alone software for GoCheck Kids Nokia.
Gobiquity, Inc.
Nokia 4.4.29
In Commercial Distribution

  • B430GCKNOK44290L ()


  • External ocular measurement camera
CAPILLAROSCOPE HIGH RESOLUTION WITH PROFESSIONAL SOFTWARE
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-318
Not in Commercial Distribution

  • B1623181 ()
FEDMEDMICFIP5MSWC_US

  • Otoscope, direct
Lilivis CAD L-CAD (Chairside CAD Software)
Huvitz Co., Ltd.
L-CAD
In Commercial Distribution

  • 08800019600909 ()
LS-100

  • CAD/CAM software
Monarch™ Laptop P16 Software v4.1.0
AURIS HEALTH, INC.
Version 4.1.0
In Commercial Distribution

  • 10810068810612 ()


  • Robotic surgical system application software
Monarch™ Laptop P17 Software v4.1.0
AURIS HEALTH, INC.
Version 4.1.0
In Commercial Distribution

  • 10810068810605 ()


  • Robotic surgical system application software
TIP, PROFUSION, MACH XL WITH SOFTWARE
SOLTA MEDICAL
40-01746
In Commercial Distribution

  • 00816995020615 ()
40-01746

  • Multi-modality skin surface treatment system
Sherlock 3CG+ TCS Software Version 3.1.0
Bard Access Systems, Inc.
Sherlock 3CG+ TCS Software Version 3.1.0
In Commercial Distribution

  • 00801741188718 ()
Sherlock 3CG+ TCS Software Version 3.1.0

  • Central venous catheter navigation system, electrocardiographic/magnetic
PillCam™ Web Software v9, USA
Given Imaging, Inc.
FGS-0639
In Commercial Distribution

  • 07290110360214 ()


  • Video capsule endoscopy system application software
SOFTWARE MMT-8061 INS PEN ANDROID APP
MEDTRONIC MINIMED, INC.
MMT-8061
In Commercial Distribution

  • 00763000489960 ()


  • Empty self-injector, mechanical
SOFTWARE MMT-8060 INSULIN PEN IOS APP
MEDTRONIC MINIMED, INC.
MMT-8060
In Commercial Distribution

  • 00763000489953 ()


  • Empty self-injector, mechanical
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