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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Meridian Medical APP System - adjustable pump and single layer pad
COMPASS HEALTH BRANDS CORP.
MER-APP2
In Commercial Distribution

  • 00815067043521 ()


  • Alternating-pressure bed mattress overlay system
SPRAY SET ENDOSCOPIC APP. 5MM, 40 CM, 1:1 RATIO
Micromedics, Inc.
SA-3655
In Commercial Distribution

  • 00815634020085 ()
  • 10815634020082 ()
  • 20815634020089 ()


  • Open-surgery adhesive/sealant applicator, dual-channel
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 Android
In Commercial Distribution

  • 09413000126273 ()


  • Electronic goniometer/kinesiology sensor
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
EBM TECHNOLOGIES INCORPORATED
MobiPACS™ App
In Commercial Distribution

  • 04719878879965 ()


  • Radiological PACS software
No Description
Phillips-Medisize A/S
Android (Mobile App)
Not in Commercial Distribution

  • 05713495000060 ()
84601063

  • Medication reminder application software
No Description
Phillips-Medisize A/S
iOS (Mobile App)
Not in Commercial Distribution

  • 05713495000053 ()
84601063

  • Medication reminder application software
No Description
EMPATICA SRL
EpiMonitor App Android
In Commercial Distribution

  • 00853858006386 ()


  • Home seizure monitoring system
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
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