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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Biim iOS App, P1.3
Biim Ultrasound AS
P001227
In Commercial Distribution

  • 07090045490181 ()
P001227

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim Android App, P1.2
Biim Ultrasound AS
P001158
In Commercial Distribution

  • 07090045490150 ()
P001158

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim iOS App, P1.2
Biim Ultrasound AS
P001157
In Commercial Distribution

  • 07090045490143 ()
P001157

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim Android App, P1.1
Biim Ultrasound AS
P001118
In Commercial Distribution

  • 07090045490020 ()
P001118

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Seer App: Epilepsy Management
SEER MEDICAL HOLDINGS LIMITED
Seer App: Epilepsy Management
Not in Commercial Distribution

  • 09355751001235 ()


  • Electroencephalograph
Seer App: Epilepsy Management
SEER MEDICAL HOLDINGS LIMITED
Seer App: Epilepsy Management
Not in Commercial Distribution

  • 09355751001051 ()


  • Electroencephalograph
G7 iOS Watch App
Dexcom, Inc.
SW13355
In Commercial Distribution

  • 00386270005168 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
MYAIR FOR IOS APP
RESMED CORP.
22245
In Commercial Distribution

  • 00840193400115 ()
22245

  • Self-care monitoring/reporting software
physIQ Medical Device Data System Android App
PHYSIQ, INC
3.4 (Edison)
In Commercial Distribution

  • 00860004366218 ()


  • Electrocardiography telemetric monitoring system
This is an application intended to be used by neurologists who are monitoring or reviewing EEGs. It is part of a larger system provided by Persyst.
Persyst Development Corp
App for Web
Not in Commercial Distribution

  • 00869732000142 ()


  • Bioelectrical signal analysis software
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