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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No Description
Clarius Mobile Health Corp
App - Android
In Commercial Distribution

  • 07540205000403 ()
12-01-00004

  • Ultrasound imaging system application software
  • Radiological PACS software
No Description
Roche Diagnostics GmbH
05918081190
In Commercial Distribution

  • 07613336180877 ()
05918081190

  • Thyroglobulin IVD, control
Anti-TG Ab is an ELISA test system for the quantitative measurement of IgG class autoantibodies against thyroglobulin (TG) in human serum or plasma.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3708
In Commercial Distribution

  • 04048474037081 ()
EIA-3708

  • Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA)
Anti-TG Ab is an ELISA test system for the quantitative measurement of IgG class autoantibodies against thyroglobulin (TG) in human serum or plasma.
DRG International Inc
EIA-3708
In Commercial Distribution

  • 00840239037084 ()
EIA-3708

  • Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Sugarmate, LLC
1007228
In Commercial Distribution

  • 00850018992435 ()


  • Self-care monitoring/reporting software
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
Philips Ultrasound LLC
795161
In Commercial Distribution

  • 00884838103405 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
Mobile Application Remote Control
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52603
In Commercial Distribution

  • 09008737526030 ()


  • Audiometric/hearing device software
No Description
BIOSERENITY MEDICAL DEVICES GROUP
5100-00012
Not in Commercial Distribution

  • 03615220002610 ()


  • Electroencephalographic monitoring 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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