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 Class Implantable

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myDigitalKnee mobile app is used with a Digital Knee sensor attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition.
OPUM TECHNOLOGIES SERVICES LIMITED
Mobile App iOS
In Commercial Distribution

  • 09413000126259 ()


  • Electronic goniometer/kinesiology sensor
No Description
EMPATICA SRL
EpiMonitor App iOS
In Commercial Distribution

  • 00853858006379 ()


  • Home seizure monitoring system
No Description
EMPATICA SRL
Care App iOS
In Commercial Distribution

  • 00853858006249 ()


  • Multiple vital physiological parameter monitoring system, home-use
No Description
Phillips-Medisize A/S
iOS (Mobile App)
Not in Commercial Distribution

  • 05713495000053 ()
84601063

  • Medication reminder application software
No Description
Ouraring Inc.
Fertile Window iOS
In Commercial Distribution

  • 06430060159990 ()


  • Menstrual cycle self-monitoring software
Software as a Medical Device (SaMD) which operates as a medication reminder and support services; Operates on Apple iOS devices.
Astellas Pharma Us, Inc.
iOS (Version 1)
In Commercial Distribution

  • 00304692416089 ()
DIGI-001

  • Medication reminder application software
Care Assist
Philips Medizin Systeme Böblingen GmbH
Care Assist iOS
In Commercial Distribution

  • 00884838127432 ()
989803221531

  • Centralized patient monitor
Protective Table Cover
DOMICO MED-DEVICE, LLC
9072
Not in Commercial Distribution

  • 00810050244848 ()
  • 10810050244845 ()


  • Medical cushion cover
COVER, PROTECTIVE, SHORT SHIELD PAD
DOMICO MED-DEVICE, LLC
9109
In Commercial Distribution

  • 00810050242691 ()
  • 10810050242698 ()


  • Medical cushion cover
COVER, PROTECTIVE, LONG SHIELD PAD
DOMICO MED-DEVICE, LLC
9110
In Commercial Distribution

  • 00810050242684 ()
  • 10810050242681 ()


  • Medical cushion cover
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