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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An application software program intended to extract, process, and store non-clinical processing data (e.g., log of equipment usage, equipment status) from medical equipment to assist process management. It is not intended for control of equipment
NEUROLIEF LTD
RLV-PMI-102
In Commercial Distribution

  • 07290018393147 ()


  • Configurable electronic form web-based application software
No Description
Nox Medical ehf.
NOX-NOXTURNAL_US_APP
In Commercial Distribution

  • 15694311111665 ()


  • Sleep disorder interpretive software, professional-only
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSLA
In Commercial Distribution

  • 50888439463963 ()
  • 10888439463965 ()
SBA11LLSLA

  • Laparoscopic surgical procedure kit, non-medicated, single-use
SYSTEM,APP,AIRONE, 220 VOLT
MEDLINE INDUSTRIES, INC.
MSCAIRONE220
In Commercial Distribution

  • 10080196403905 ()
MSCAIRONE220

  • Alternating-pressure bed mattress overlay, reusable
APP,KS CHOICE,3.2.2,ANDR
Gn Hearing A/S
20425500
In Commercial Distribution

  • 05708296076703 ()


  • Hearing aid/implant system remote control
APP,GNH TUNER,3.4,ANDR
Gn Hearing A/S
20417000
In Commercial Distribution

  • 05708296074259 ()


  • Hearing aid/implant system remote control
APP,BT HEARP,3.4,ANDR
Gn Hearing A/S
20416800
In Commercial Distribution

  • 05708296074235 ()


  • Hearing aid/implant system remote control
APP,RS SMART,3.4,ANDR
Gn Hearing A/S
20416600
In Commercial Distribution

  • 05708296074211 ()


  • Hearing aid/implant system remote control
APP,BT HEARMAX,1.0,ANDR
Gn Hearing A/S
20410900
In Commercial Distribution

  • 05708296071548 ()


  • Hearing aid/implant system remote control
SOFTWARE 9733467 FUSION ENT APP
MEDTRONIC NAVIGATION, INC.
9733467
In Commercial Distribution

  • 00643169491748 ()


  • ENT stereotactic surgery system
Android Hearing Aid Programming App
HEARX GROUP (PTY) LTD
Lexie Android App
In Commercial Distribution

  • 00850022464256 ()
Lexie Android App

  • Audiometric/hearing device software
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL1
In Commercial Distribution

  • 50888439686430 ()
  • 10888439686432 ()
SBA11LLSL1

  • Laparoscopic surgical procedure kit, non-medicated, single-use
J TONG MED/LGE-No App
OSSUR AMERICAS, INC.
JT-115
Not in Commercial Distribution

  • 05690977308701 ()
JT-115

  • Traction system skull tongs
SW APP A901 COMM MANAGER
MEDTRONIC, INC.
A901
In Commercial Distribution

  • 00643169738058 ()


  • Multiple active implantable device programmer
SW APP A710 SCS CLINICIAN
MEDTRONIC, INC.
A710
In Commercial Distribution

  • 00643169738041 ()


  • Multiple active implantable device programmer
Protekt Adjustable APP Pump Only
PROACTIVE MEDICAL PRODUCTS, LLC
80010-PUMP
In Commercial Distribution

  • 05060488570377 ()

  • Width: 13 Inch
  • Length: 7.5 Inch
  • Height: 9 Inch
80010-PUMP

  • Alternating-pressure bed mattress overlay system
Tinnitus app Android version 1.0
Widex A/S
Tinnitus app
In Commercial Distribution

  • 05706069674729 ()
5 300 0007 001

  • Tinnitus masking application software
BEYOND app Android version 1.1
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069673579 ()
5 300 0005 001

  • Hearing aid/implant system remote control
APP,AUDIGY ATTUNE,1.2,ANDR
Gn Hearing A/S
20789100
In Commercial Distribution

  • 05708296097258 ()


  • Hearing aid/implant system remote control
APP,TUNER,TRUHEARING,3.5,ANDR
Gn Hearing A/S
20681500
In Commercial Distribution

  • 05708296095575 ()


  • Hearing aid/implant system remote control
APP,GNH BEMORE,1.1,ANDR
Gn Hearing A/S
20664000
In Commercial Distribution

  • 05708296095308 ()


  • Hearing aid/implant system remote control
APP,GNH TUNER,4.0,ANDR
Gn Hearing A/S
20993700
In Commercial Distribution

  • 05708296158478 ()


  • Hearing aid/implant system remote control
APP,RS SMART,4.0,ANDR
Gn Hearing A/S
20993300
In Commercial Distribution

  • 05708296158430 ()


  • Hearing aid/implant system remote control
APP,KS CHOICE,4.0,ANDR
Gn Hearing A/S
20993100
In Commercial Distribution

  • 05708296158416 ()


  • Hearing aid/implant system remote control
APP,BT HEARP,4.0,ANDR
Gn Hearing A/S
20993500
In Commercial Distribution

  • 05708296158454 ()


  • Hearing aid/implant system remote control
APP,MY LIVELY 1.4,ANDR
Gn Hearing A/S
21123100
In Commercial Distribution

  • 05708296169719 ()


  • Hearing aid/implant system remote control
APP,KS DISCOVER,1.4,ANDR
Gn Hearing A/S
20665300
In Commercial Distribution

  • 05708296164301 ()


  • Hearing aid/implant system remote control
APP,JABRA,ENHANCE PRO,ANDR
Gn Hearing A/S
21820100
In Commercial Distribution

  • 05708296214655 ()


  • Hearing aid/implant system remote control
APP WIDEX REMOTE CARE ANDROID
Widex A/S
Remote Care 1.3.4
In Commercial Distribution

  • 05706069779714 ()
21035228

  • Hearing aid/implant system remote control
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL2
In Commercial Distribution

  • 50888439768440 ()
  • 10888439768442 ()
SBA11LLSL2

  • Laparoscopic surgical procedure kit, non-medicated, single-use
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