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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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
Philips Ultrasound LLC
795161
In Commercial Distribution

  • 00884838103405 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
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
Eversense Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-02-300
In Commercial Distribution

  • 00817491023520 ()
FG-5501-02-300

  • Implantable glucose monitoring system
No Description
Thought Technology Ltd.
SA4520
In Commercial Distribution

  • 07540191000623 ()


  • Psychophysiological biofeedback system
TG Ab Ancillary Diluent - Atellica IM - CONS - 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995463
In Commercial Distribution

  • 00630414597904 ()
  • 00630414007304 ()
10995463

  • Buffered sample diluent IVD
4.8mm TG Hex Abutment Plastic Sleeve Hexed with Ti. Screw
TITAN IMPLANT INC
TN-48TGHAPSH
In Commercial Distribution

  • 00842448115621 ()


  • Dental implant suprastructure, temporary, preformed, single-use
T-CONNECT FOR SINGLE CROWN PREMIUM TG W H.4 MM
SWEDEN & MARTINA SPA
A-TG-BASTZR-S-W-4
In Commercial Distribution

  • D7701220983 ()
A-TG-BASTZR-S-W-4

  • Dental implant suprastructure, permanent, preformed
T-CONNECT FOR SINGLE CROWN PREMIUM TG M H.4 MM
SWEDEN & MARTINA SPA
A-TG-BASTZR-S-M-4
In Commercial Distribution

  • D7701220953 ()
A-TG-BASTZR-S-M-4

  • Dental implant suprastructure, permanent, preformed
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