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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
STRYKER CORPORATION
EMDAN 2.3.0
In Commercial Distribution

  • 00860002177748 ()
910-01956

  • Alarm application software
No Description
STRYKER CORPORATION
EMDAN 2.2.0
In Commercial Distribution

  • 00860002177717 ()
910-01955

  • Alarm application software
Cleerly ISCHEMIA is an add-on software module to Cleerly Labs (K202280, K190868) that determines the likely presence or absence of coronal vessel ischemia.
CLEERLY, INC.
v1.0
In Commercial Distribution

  • 00860001924121 ()


  • Radiological PACS software
Education Unit for Movive
Medrhythms, Inc.
005EDU
In Commercial Distribution

  • 00860001790832 ()


  • Neuromuscular rehabilitation software
Movive is indicated to support gait rehabilitation and motor function for people living with Parkinson's disease. Movive is intended to be used in the home for the physical rehabilitation of ambulatory adults with walking impairments from Parkinson's disease.
Medrhythms, Inc.
0050
In Commercial Distribution

  • 00860001790818 ()


  • Neuromuscular rehabilitation software
UltraRAD Product User Web Interface
ULTRARAD CORPORATION
1.0.0.12
In Commercial Distribution

  • 00860001148589 ()


  • Radiological PACS software
DICOM Viewer
ULTRARAD CORPORATION
6.0.0.0
In Commercial Distribution

  • 00860001148565 ()


  • Radiological PACS software
DICOM file import tool
ULTRARAD CORPORATION
1.0.0.0
In Commercial Distribution

  • 00860001148541 ()


  • Radiological PACS software
DICOM Router
ULTRARAD CORPORATION
3.0.4.9
In Commercial Distribution

  • 00860001148527 ()


  • Radiological PACS software
Allows sites a methodology to securely deliver electronic results and images to their referring physicians
ULTRARAD CORPORATION
1.0.0.2
In Commercial Distribution

  • 00860001148510 ()


  • Radiological PACS software
Clinical image viewer
ULTRARAD CORPORATION
2.0.0.0
In Commercial Distribution

  • 00860001148503 ()


  • Radiological PACS software
The IRIS software is a software as a service application that is hosted on the internet which allows clinicians the ability to scan a patient's retina with a fundus camera, transmit the images up to a website and offer an opinion on the scans. It also allows users the ability to input data relative to a visual fields exam.
INTELLIGENT RETINAL IMAGING SYSTEMS, LLC
3.0
In Commercial Distribution

  • 00860001130508 ()


  • Ophthalmology PACS software
DI DLS
Ortho2, LLC
6.1.1
In Commercial Distribution

  • 00860001048506 ()


  • Radiological PACS software
No Description
COGNIVUE, INC.
Portable Device Model 2
In Commercial Distribution

  • 00860000564052 ()


  • Cognitive assessment software
No Description
COGNIVUE, INC.
Portable Device
In Commercial Distribution

  • 00860000564038 ()


  • Cognitive assessment software
No Description
COGNIVUE, INC.
Desktop Unit
In Commercial Distribution

  • 00860000564014 ()


  • Cognitive assessment software
Prescription Digital Therapeutic for the Treatment of Pediatric Amblyopia
Luminopia, Inc.
2.0
In Commercial Distribution

  • 00860007887123 ()


  • Vision training software
Prescription Digital Therapeutic for the Treatment of Pediatric Amblyopia - 90 Day
Luminopia, Inc.
2.0
In Commercial Distribution

  • 00860007887116 ()


  • Vision training software
Prescription Digital Therapeutic for the Treatment of Pediatric Amblyopia - 30 Day
Luminopia, Inc.
2.0
In Commercial Distribution

  • 00860007887109 ()


  • Vision training software
3D Brachy Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during surface brachytherapy. The use of 3D Brachy application is by prescription only.
Adaptiiv Medical Technologies Inc
v2021.1.0
In Commercial Distribution

  • 00860007402326 ()


  • Radiation therapy software
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