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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Integra® Miltex® Scaler H5/33, Double-Ended, Octagonal Handle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
70-124
In Commercial Distribution

  • 10381780450245 ()
  • H8347001240 ()
70-124

  • Manual dental scaler, reusable
Mobile version
3DIEMME SRL
RealGUIDE APP
In Commercial Distribution

  • 08050038830003 ()


  • CAD/CAM software
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
Pjama AB
DryGuardians App
In Commercial Distribution

  • 07350078445160 ()
4200

  • Incontinence sensor/alarm
Reference strain
Ssi Diagnostica A/S
85340
In Commercial Distribution

  • 05713106853405 ()
85340

  • Escherichia coli antigen IVD, control
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
Sugarmate, LLC
1007228
In Commercial Distribution

  • 00850018992435 ()


  • Self-care monitoring/reporting software
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
No Description
Philips Ultrasound LLC
795161
In Commercial Distribution

  • 00884838103405 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
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