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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myPhonak 4.0 app
Sonova AG
088-0013-21
In Commercial Distribution

  • 07613389399271 ()
088-0013-21

  • Audiometric/hearing device software
SCS Programming App
NALU MEDICAL, INC.
53001
In Commercial Distribution

  • 00812537030463 ()
53001

  • Implantable electrical stimulation device management software
Holter Mobile App
Lifesignals, Inc.
UA2251-R
In Commercial Distribution

  • B353UA2251R1 ()


  • Medical equipment clinical data interfacing software
Dialogue AAC App
PRENTKE ROMICH COMPANY
Dialogue App
In Commercial Distribution

  • 00816486021183 ()
18312

  • Voice synthesizer/digitizer
TouchChat HD App
PRENTKE ROMICH COMPANY
TouchChat App
In Commercial Distribution

  • 00816486021053 ()
18626-4

  • Voice synthesizer/digitizer
Classic TouchChat App
PRENTKE ROMICH COMPANY
TouchChat App
In Commercial Distribution

  • 00816486021022 ()
18626-0

  • Voice synthesizer/digitizer
SmartView Connect App
MICROPORT CRM SRL
SW001U
In Commercial Distribution

  • 08031527019932 ()
SW001U

  • Cardiology information system application software
No Description
Roche Diagnostics GmbH
08906556160
In Commercial Distribution

  • 07613336203569 ()
08906556160

  • Thyroglobulin IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08991405190
In Commercial Distribution

  • 07613336171394 ()
08991405190

  • Thyroglobulin IVD, calibrator
No Description
Roche Diagnostics GmbH
08906564190
In Commercial Distribution

  • 07613336169582 ()
08906564190

  • Thyroglobulin IVD, kit, chemiluminescent immunoassay
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