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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No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
DA-IOSDriver
In Commercial Distribution

  • 10841307128205 ()
DA-IOSDriver

  • Surgical screwdriver, reusable
Eversense 365 Mobile Application for iOS is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5503-06-300
In Commercial Distribution

  • 00817491024268 ()
FG-5503-06-300

  • Implantable glucose monitoring system
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
Care Assist
Philips Medizin Systeme Böblingen GmbH
Care Assist iOS
In Commercial Distribution

  • 00884838127432 ()
989803221531

  • Centralized patient monitor
No Description
Ouraring Inc.
Fertile Window iOS
In Commercial Distribution

  • 06430060159990 ()


  • Menstrual cycle self-monitoring software
Software as a Medical Device (SaMD) which operates as a medication reminder and support services; Operates on Apple iOS devices.
Astellas Pharma Us, Inc.
iOS (Version 1)
In Commercial Distribution

  • 00304692416089 ()
DIGI-001

  • Medication reminder application software
1, Needle App 18ga x 20cm Brachytherapy Non-Waxed, St
STELLAR MEDICAL, LLC
NA-1820SQ-NWS
In Commercial Distribution

  • 00853162006416 ()


  • Radiological image marker, implantable
  • Brachytherapy injection needle
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