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 Class Implantable

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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
Thought Technology Ltd.
SA4520
In Commercial Distribution

  • 07540191000623 ()


  • Psychophysiological biofeedback system
No Description
Philips Ultrasound LLC
795161
In Commercial Distribution

  • 00884838103405 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
iOS smartphone application for MODD1 Insulin Delivery System, software version v1.X
Modular Medical, Inc.
MODD1 Insulin Delivery System
In Commercial Distribution

  • 00850037806010 ()
MTL-103

  • Ambulatory insulin infusion pump software, patient-dosing
FeetMe Rehabilitation mobile application corresponding to iOS version 1.Y.Z
FEETME
1
In Commercial Distribution

  • 03760349820024 ()


  • Biomechanical function analysis/rehabilitation software
IOS & Android based APP used to control RxEars RX7 BTE device.
Persona Medical
RxEars APP
In Commercial Distribution

  • 00851362008025 ()


  • Air-conduction hearing aid, behind-the-ear
Scan Body with Screw Compatible with Osstem (Hiossen) TSIII Regular IOS
Biodenta Swiss AG
CAD-SBOTS45
In Commercial Distribution

  • 07640169731419 ()
CAD-SBOTS45

  • Dental implant abutment analog, intraoral-scanning, single-use
Scan Body with Screw Compatible with Osstem (Hiossen) TSIII Mini IOS
Biodenta Swiss AG
CAD-SBOTS35
In Commercial Distribution

  • 07640169731402 ()
CAD-SBOTS35

  • Dental implant abutment analog, intraoral-scanning, single-use
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