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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App Control for ACRL-9100 Device v.1
COMPASS HEALTH BRANDS CORP.
ACRL-9100APP
In Commercial Distribution



  • Physical therapy transcutaneous neuromuscular electrical stimulation system
App Control for ACRL-9100 Device v.0
COMPASS HEALTH BRANDS CORP.
ACRL-9100APP
Not in Commercial Distribution

  • 00023601091000 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
G5 Mobile Android App Stand Alone Software
Dexcom, Inc.
SW10940
In Commercial Distribution

  • 00386270000293 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75751
In Commercial Distribution

75751

  • Rectal irrigation system application software
SW MMT-8061 INPEN 2.0 ANDROID APP US
MEDTRONIC MINIMED, INC.
MMT-8061
In Commercial Distribution

  • 00763000974596 ()


  • Empty self-injector, mechanical
A mobile app for HANSATON hearing instruments
Sonova AG
088-5018
In Commercial Distribution

  • 07613389610932 ()


  • Audiometric/hearing device software
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75751
Not in Commercial Distribution

  • 07392532242380 ()
75751

  • Rectal irrigation system application software
SFTWR CSS7201 GRDN MBL APP ANDRD V4.1.1
MEDTRONIC MINIMED, INC.
CSS7201
In Commercial Distribution

  • 00763000381097 ()


  • Patient health record information system application software
SW APP A71300 SCS CLINICIAN TRIALING 2.0
MEDTRONIC, INC.
A71300
In Commercial Distribution

  • 00763000533199 ()


  • Multiple active implantable device programmer
SW D00U027 SS LINQ II PLATFORM APP
MEDTRONIC, INC.
D00U027
In Commercial Distribution

  • 00763000891091 ()


  • Implantable cardiac device management application software
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