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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BENZOYLECGONINE 1
UTAK LABORATORIES, INC.
BE M 1 VTS
In Commercial Distribution

  • B800BEM1VTS5 ()
  • B800BEM1VTS0 ()

  • Total Volume: 25 Milliliter
BE M 1 VTS

  • Multiple-type clinical chemistry analyte profile IVD, control
MORPHINE PLUS
UTAK LABORATORIES, INC.
MOR+ U F VTS
In Commercial Distribution

  • B800MORUFVTS5 ()
  • B800MORUFVTS0 ()

  • Total Volume: 2 Milliliter
MOR+ U F VTS

  • Multiple-type clinical chemistry analyte profile IVD, control
An iOS mobile application used to adjust Sonify Hearing wireless OTC hearing aids.
Novidan, Inc.
99-0011-08
In Commercial Distribution

  • 00850049194037 ()


  • Air-conduction hearing aid, receiver-in-canal
An iOS platform mobile application used to adjust NoviMed wireless OTC hearing aids.
Novidan, Inc.
99-0011-10
In Commercial Distribution

  • 00850049194013 ()


  • Air-conduction hearing aid, receiver-in-canal
TG Ab QC Kit - Atellica IM - CLT 2 x 3 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995465
In Commercial Distribution

  • 00630414597928 ()
10995465

  • Thyroglobulin antibody IVD, control
TG Ab - Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995464
In Commercial Distribution

  • 00630414597911 ()
10995464

  • Thyroglobulin antibody IVD, control
No Description
Ouraring Inc.
Fertile Window iOS
In Commercial Distribution

  • 06430060159990 ()


  • Menstrual cycle self-monitoring software
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
No Description
Phillips-Medisize A/S
iOS (Mobile App)
Not in Commercial Distribution

  • 05713495000053 ()
84601063

  • Medication reminder application software
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