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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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CEM Viewer for NAVIS-EX - 04987669101353

The CEM Viewer for NAVIS-EX software (hereafter referred to as CEM Viewer) is used to view the examination data of the SPECULAR MICROSCOPE CEM-530 or use the data for follow-up within IMAGE FILING SOFTWARE NAVIS-EX. This function is added to the computer as a plug-in for NAVIS-EX. The examination data is displayed, analyzed, and used for follow-up. CEM Viewer can be used to display examination data on the Viewer screen or follow up data on the Follow-Up screen. The examination data is saved and managed within NAVIS-EX. The CEM Viewer data is imported to NAVIS-EX using separate software, Data Acquisition Service for NAVIS-EX.
NIDEK CO.,LTD.
1.1
In Commercial Distribution

  • 04987669101353 ()


  • Eye anterior segment analyser software

WAVENET - 00380659908170

ALLEGRETTO WAVE EYE-Q EXCIMER
Alcon Laboratories, Inc.
8065990817
Not in Commercial Distribution

  • 00380659908170 ()
8065990817

  • Laser application software

WAVENET - 00380650004567

WAVENET PLANNING SOFTWARE
Alcon Laboratories, Inc.
8065000456
In Commercial Distribution

  • 00380650004567 ()


  • Laser application software

ANTERION - 04059237000952

No Description
Heidelberg Engineering GmbH
Software V.1.5 US
In Commercial Distribution

  • 04059237000952 ()


  • Eye anterior segment analyser software

Data Logger Bravo (T) - 07540196002394

Data logger for Bravo Chamber Autoclave
Scican Ltd
01-111730
In Commercial Distribution

  • 07540196002394 ()
01-111730

  • Digital storage media

Data Logger Bravo (G) - 07540196002387

Data logger for Bravo Chamber Autoclave
Scican Ltd
01-111729
In Commercial Distribution

  • 07540196002387 ()
01-111729

  • Digital storage media

Data Logger Statim/Hydrim - 07540196000963

Data logger for Statim Cassette Autoclaves and Hydrim Instrument Washers
Scican Ltd
01-111770
In Commercial Distribution

  • 07540196000963 ()
01-111770

  • Digital storage media

CareLink - 00763000253325

KIT MMT-7306 USB CARELINK 2.4 RF INSERT
MEDTRONIC MINIMED, INC.
MMT-7306
In Commercial Distribution

  • 00763000253325 ()


  • Digital storage media

REMI Robotic Navigation System - 00850026574364

Spine System Software
Fusion Robotics, LLC
5005
In Commercial Distribution

  • 00850026574364 ()


  • Robotic surgical navigation system application software

ORTHOMAP - 04546540651624

ORTHOMAP¿ 3D 2.0 - PLANNING
Stryker Leibinger GmbH & Co. KG
6005-661-000
In Commercial Distribution

  • 04546540651624 ()
6005-661-000

  • Robotic surgical navigation system application software
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