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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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Software Package
DEVICOR MEDICAL PRODUCTS, INC.
SCMSW6
In Commercial Distribution

  • 00841911101833 ()
SCMSW6

  • Mammographic stereotactic biopsy system
Fitting Software
INTRICON CORPORATION
Accu-Fit
In Commercial Distribution

  • 00858177007236 ()
23115

  • Hearing aid wireless-fitting computer-aided set
Software Application
SEMLER SCIENTIFIC, INC.
52-0100
In Commercial Distribution

  • 00859433006123 ()


  • Limb plethysmograph
Software Disk
Fujirebio Diagnostics, Inc.
CL0004
In Commercial Distribution

  • 00869164000017 ()


  • Laboratory instrument/analyser application software IVD
TrackX Software
TrackX Technology, LLC
TrackX Software
In Commercial Distribution

  • 00860099000837 ()
N/A

  • Diagnostic x-ray digital imaging system workstation application software
Acculink Software
Natus Medical Denmark ApS
8-49-88800
In Commercial Distribution

  • 05713315008672 ()
8-49-88800

  • Evoked-potential audiometer
PC Software
ACON LABORATORIES, INC.
1.2.89
In Commercial Distribution

  • 00682607001118 ()


  • Glucose monitoring system IVD, home-use
  • Glucose monitoring system IVD, point-of-care
NOVA Software
DIOPSYS, INC.
NOVA 2.19
In Commercial Distribution

  • 00850514007091 ()


  • Vision electrophysiology analysis system
Cadi Software
Synca Marketing Inc
V8
In Commercial Distribution

  • 00066714700155 ()
CADI

  • Radiology information system application software
Playbook Software
ORTHOPEDIATRICS CORP.
PLAYBOOKMDDS
In Commercial Distribution

  • 00840194493871 ()
PLAYBOOKMDDS

  • Medical image management system
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