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 Class Implantable

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Software, Sonicare Power Tooth brush, Web download App iOS
PHILIPS ORAL HEALTHCARE, LLC
HX9999/99
In Commercial Distribution

  • 08710103988977 ()


  • Basic electric toothbrush
t:connect Mobile Application, Mobile Bolus Enabled, 2.x (iOS)
Tandem Diabetes Care, Inc.
1007111
In Commercial Distribution

  • 90850018992452 ()


  • Ambulatory insulin infusion pump software, data-display
  • Ambulatory insulin infusion pump remote control
No Description
Sugarmate, LLC
1007228
In Commercial Distribution

  • 00850018992435 ()


  • Self-care monitoring/reporting software
iOS smartphone application for MODD1 Insulin Delivery System, software version v1.X
Modular Medical, Inc.
MODD1 Insulin Delivery System
In Commercial Distribution

  • 00850037806010 ()
MTL-103

  • Ambulatory insulin infusion pump software, patient-dosing
Mobile Application Remote Control
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52603
In Commercial Distribution

  • 09008737526030 ()


  • Audiometric/hearing device software
No Description
Philips Ultrasound LLC
795161
In Commercial Distribution

  • 00884838103405 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
Clinical decision support software indicated for use by licensed clinicians to inform the detection of disease utilizing an iOS client.
AMBIENT CLINICAL ANALYTICS, INC.
1.0
In Commercial Distribution

  • 00850893007033 ()


  • Clinical management support software
No Description
BIOSERENITY MEDICAL DEVICES GROUP
5100-00012
Not in Commercial Distribution

  • 03615220002610 ()


  • Electroencephalographic monitoring system
No Description
Thought Technology Ltd.
SA4520
In Commercial Distribution

  • 07540191000623 ()


  • Psychophysiological biofeedback system
FeetMe Rehabilitation mobile application corresponding to iOS version 1.Y.Z
FEETME
1
In Commercial Distribution

  • 03760349820024 ()


  • Biomechanical function analysis/rehabilitation software
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