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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IOS Implant Replica Nobel Biocare N1™ TCC NP
Nobel Biocare AB
300964
In Commercial Distribution

  • 07332747176995 ()
300964

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Implant Replica Nobel Biocare N1™ TCC RP
Nobel Biocare AB
300965
In Commercial Distribution

  • 07332747162899 ()
300965

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Implant Replica Nobel Biocare N1™ TCC NP
Nobel Biocare AB
300964
In Commercial Distribution

  • 07332747162882 ()
300964

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Implant Replica Nobel Biocare N1™ TCC RP
Nobel Biocare AB
300965
In Commercial Distribution

  • 07332747214222 ()
300965

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Implant Replica Nobel Biocare N1™ TCC NP
Nobel Biocare AB
300964
In Commercial Distribution

  • 07332747214215 ()
300964

  • Dental implant suprastructure, temporary, preformed, single-use
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
No Description
Sugarmate, LLC
1007228
In Commercial Distribution

  • 00850018992435 ()


  • Self-care monitoring/reporting software
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
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
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