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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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CEREC SW v5.2 (licence)
SIRONA Dental Systems GmbH
6772714
In Commercial Distribution

  • E27667727140 ()


  • CAD/CAM software
CEREC Premium CAM 4.4.4 Software
SIRONA Dental Systems GmbH
6610591
In Commercial Distribution

  • E27666105910 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
No Description
EUROIMMUN Medizinische Labordiagnostika AG
YG 0671-0101-2
In Commercial Distribution

  • 04049016151012 ()


  • Laboratory instrument/analyser application software IVD
The SYNCT Software is a desktop application that can be utilized by an end-user on a standalone computer, providing users the ability to operate general functions such as Order Management, with or without a Laboratory Information System (LIS), viewing test results, reviewing and preparing test reports, performing software administrative functions, and providing security control for permitted functions.
LUMINEX CORPORATION
CN-SW47
In Commercial Distribution

  • 00840487100448 ()


  • Laboratory instrument/analyser application software IVD
A cloud-based, PACS-server software application that gives dental organizations web access to patient images that have been captured from any DICOM-enabled device.
MASTERLINK LLC
1
In Commercial Distribution

  • D875403051 ()


  • General-purpose dental x-ray system application software
Dental imaging capture, enhance and display software.
MASTERLINK LLC
1
In Commercial Distribution

  • D875400101 ()


  • General-purpose dental x-ray system application software
B125/B105 V1.5 SW PACK (USB) - MD
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V1.5
Not in Commercial Distribution

  • 00840682141291 ()


  • General-purpose multi-parameter bedside monitor
No Description
Gynesonics, Inc.
SW-002
In Commercial Distribution

  • 10817929020340 ()
SW-002

  • Ultrasound-guided radio-frequency ablation system software
No Description
Carl Zeiss Meditec AG
5
In Commercial Distribution

  • 04049539070302 ()


  • Operating room audiovisual data/device management system
Cranial Guidance Enable
Stryker Leibinger GmbH & Co. KG
6000-670-300
In Commercial Distribution

  • 07613327538410 ()
6000-670-300

  • Electromagnetic/optical surgical navigation device tracking system
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