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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 Application
SEMLER SCIENTIFIC, INC.
52-0100
In Commercial Distribution

  • 00859433006123 ()


  • Limb plethysmograph
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
Acculink Software
Natus Medical Denmark ApS
8-49-88800
In Commercial Distribution

  • 05713315008672 ()
8-49-88800

  • Evoked-potential audiometer
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
TAGconnect Software
WELCH ALLYN, INC.
901099
In Commercial Distribution

  • 00732094296334 ()
TAGECG-SWF

  • Electrocardiographic ambulatory recorder
Fitting Software
INTRICON CORPORATION
Accu-Fit
In Commercial Distribution

  • 00858177007236 ()
23115

  • Hearing aid wireless-fitting computer-aided set
SentrySuite Software
Jaeger Medical GmbH
2.15
In Commercial Distribution

  • 04250892904634 ()
V-770843-13

  • Pulmonary function analysis system, adult
SentrySuite Software
Jaeger Medical GmbH
2.19
In Commercial Distribution

  • 04250892904627 ()
V-770845-13

  • Pulmonary function analysis system, adult
SentrySuite Software
Jaeger Medical GmbH
2.21
In Commercial Distribution

  • 04250892904610 ()
V-770846

  • Pulmonary function analysis system, adult
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