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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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Ikaros - 04250406400003

No Description
MetaSystems Hard & Software GmbH
Karyotyping System
In Commercial Distribution

  • 04250406400003 ()


  • Karyotyping cell-image analyser IVD

PhySoft AMS - 00861858000303

PhySoft AMS™ is a web application used to obtain, track and trend patient data pertaining to the management of anemia, and to provide a schedule of erythropoiesis stimulating agent (ESA) dosage recommendations to help achieve and maintain target hemoglobin levels in dialysis patients. PhySoft AMS™ is intended to help physicians, nurses, clinicians and anemia managers manage anemia in adult stage 5 chronic kidney disease (CKD) patients.
PHYSICIAN SOFTWARE SYSTEMS, LLC
1
In Commercial Distribution

  • 00861858000303 ()


  • Nephrology information system application software

Orchestrate 3D - 00860008123404

Orthodontic Software
Orchestrate 3d
1
In Commercial Distribution

  • 00860008123404 ()


  • Dental milling system, CAD/CAM, chairside

CS MODEL+ - 00693856000302

LICENCE CS MODEL+ V5 ALIGNER CAPABILITY
Dental Imaging Technologies Corporation
594483
In Commercial Distribution

  • 00693856000302 ()
594483

  • CAD/CAM software

3Shape Ortho System - 05902768365283

3Shape’s Ortho System™ is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analyzing, inspecting and visualize 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets on the 3D models and design of orthodontic appliances based on 3D scanned orthodontic models, including transfer methods for indirect bonding of brackets. Output includes only Export Model (also called dental casts), Custom Metal Bands (also called metal bands), and Indirect Bonding Transfer Trays (also called orthodontic bracket placement trays). All devices are to be fabricated from FDA cleared materials.
3shape A/S
2015-1
Not in Commercial Distribution

  • 05902768365283 ()


  • CAD/CAM software

Automate - 05902729753821

The 3Shape Automate software is a web service for automatic design of crowns
3shape A/S
R1.2
In Commercial Distribution

  • 05902729753821 ()


  • Dental treatment application software

Automate - 05902729753654

DentalSystem-backed web service for automatic designs of crowns.
3shape Trios A/S
R1.0
Not in Commercial Distribution

  • 05902729753654 ()


  • Dental treatment application software

Splint Design - 05902729753555

Dental treatment application software
3shape A/S
R1.0
In Commercial Distribution

  • 05902729753555 ()


  • Dental treatment application software

Ortho System - 05902729753487

Ortho System is a software system intended for use as a medical front-end for orthodontic clinics and laboratories. It supports orthodontic diagnosis, treatment planning and follow-up, CAD modelling of orthodontic appliances and indirect bonding as well as archiving of case information.
3shape A/S
85.x
In Commercial Distribution

  • 05902729753487 ()


  • Dental treatment application software

Splint Design - 05902729752954

Dental treatment application software
3shape A/S
1.1.x
Not in Commercial Distribution

  • 05902729752954 ()


  • Dental treatment application software
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