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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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iotaSOFT Insertion System - 00850002960020

iotaSOFT Console
Iotamotion, Inc.
IM-02
In Commercial Distribution

  • 00850002960020 ()


  • Robotic surgical system application software

iotaSOFT Insertion System - 00850002960006

iotaSOFT Drive Unit
Iotamotion, Inc.
IM-00
In Commercial Distribution

  • 00850002960006 ()


  • Robotic surgical system application software

Mintal Tracker - 04595318292019

No Description
HICLUB, INC.
/
In Commercial Distribution

  • 04595318292019 ()


  • Sleep disorder interpretive software, patient-use

NA - 04582275250428

No Description
KONAN MEDICAL, INC.
Cellchek
Not in Commercial Distribution

  • 04582275250428 ()


  • Eye anterior segment analyser software

Iradimed - 00856038001157

MRIDIUM 3860 DERS LIBRARY KIT
IRADIMED CORP.
1145
In Commercial Distribution

  • 00856038001157 ()
1145

  • Infusion pump medication-dosage application software

Cerner Motion Health - 00853023006180

No Description
Cerner Corporation
MotionHealth2016.22
Not in Commercial Distribution

  • 00853023006180 ()


  • Biomechanical function analysis/rehabilitation software

OrthoView - 05060687387516

OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded into it. This enables the surgeon to gather measurements and angles of anatomical landmarks, visualize the effect of the surgery by animating regions of the image, size and position templates representing prosthetic or fixation devices and output reports specifying the measurements and device decisions.
MERIDIAN TECHNIQUE LIMITED
OrthoView
In Commercial Distribution

  • 05060687387516 ()
OrthoView

  • Orthopaedic/craniofacial implantation planning software

NeckCare Exercises - 05694230564026

The NeckCare Exercises are used to measure, record, analyze, and report head motion during instructed head-neck movements.
NeckCare Holding ehf
v1.1
In Commercial Distribution

  • 05694230564026 ()


  • Biomechanical function analysis/rehabilitation software

KinetikosMovD - 05600638781835

No Description
KINETIKOS - DRIVEN SOLUTIONS, S.A.
0,1
In Commercial Distribution

  • 05600638781835 ()


  • Biomechanical function analysis/rehabilitation software

KinetikOS - 05600638781828

The KinetikOS software is a cloud-based software as a medical device (SaMD) that utilizes data generated by various sensors from portable or wearable consumer electronics such as smartphones and smartwatches and provides gait-related data analytics. Gait-related measurements and analytics are provided to compatible 3rd-party software via APIs for displaying data, generating reports, performing further analysis and/or integrating data into their digital health software or apps, for the purpose of monitoring and understanding individual user’s general mobility or gait-related health conditions by qualified healthcare providers.
KINETIKOS - DRIVEN SOLUTIONS, S.A.
0,1
In Commercial Distribution

  • 05600638781828 ()


  • Biomechanical function analysis/rehabilitation software
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