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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 5.2 & Pro SW-Upgrade digital
SIRONA Dental Systems GmbH
6823111
In Commercial Distribution

  • E27668231110 ()
6823111

  • CAD/CAM software
CEREC SW v5.2 licence upgrade
SIRONA Dental Systems GmbH
6823103
In Commercial Distribution

  • E27668231030 ()
6823103

  • CAD/CAM software
CEREC SW V5.3
SIRONA Dental Systems GmbH
6820893
In Commercial Distribution

  • E27668208930 ()
6820893

  • CAD/CAM software
CEREC SW v5.2 licence upgrade
SIRONA Dental Systems GmbH
6783224
In Commercial Distribution

  • E27667832240 ()


  • CAD/CAM software
CEREC SW v5.2 (full version & pro module)
SIRONA Dental Systems GmbH
6727710
In Commercial Distribution

  • E27667727710 ()


  • CAD/CAM software
CEREC SW v5.2 (licence upgrade club)
SIRONA Dental Systems GmbH
6772755
In Commercial Distribution

  • E27667727550 ()


  • CAD/CAM software
CEREC SW v5.2 (licence key upgrade)
SIRONA Dental Systems GmbH
6772722
In Commercial Distribution

  • E27667727220 ()


  • CAD/CAM software
CEREC SW v5.2 (licence)
SIRONA Dental Systems GmbH
6772714
In Commercial Distribution

  • E27667727140 ()


  • CAD/CAM software
CEREC Software Version 5.1.0 Licence Upgrade Club
SIRONA Dental Systems GmbH
6731785
In Commercial Distribution

  • E27667317850 ()


  • CAD/CAM software
CEREC Software Version 5.1.0 Upgrade
SIRONA Dental Systems GmbH
6731637
In Commercial Distribution

  • E27667316370 ()


  • CAD/CAM software
CEREC SW v5.2 (actual software)
SIRONA Dental Systems GmbH
6727460
In Commercial Distribution

  • E27667274600 ()


  • 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
CEREC Premium CAM 4.5.0 Software
SIRONA Dental Systems GmbH
6610443
In Commercial Distribution

  • E27666104430 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
CEREC Software Version 5.1.0 Licence
SIRONA Dental Systems GmbH
6732361
In Commercial Distribution

  • E26767323610 ()


  • CAD/CAM software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10855671
Not in Commercial Distribution

  • 04056869001067 ()


  • Radiological PACS software
syngo Application Software VD3; covered by NFJ to K170747/K173611 syngo Application Software VD2
Siemens Healthcare GmbH
11328180
In Commercial Distribution

  • 04056869262567 ()


  • Basic diagnostic x-ray system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11149926
Not in Commercial Distribution

  • 04056869006840 ()


  • Radiological PACS software
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
No Description
RENISHAW MAYFIELD
neuroinspire SW Atlas Module
In Commercial Distribution

  • 03662724000482 ()
001.0123

  • Neurological stereotactic surgery system
No Description
RENISHAW MAYFIELD
neuroinspire planning software
In Commercial Distribution

  • 03662724000390 ()
001.0142

  • Neurological stereotactic surgery system
No Description
FOURNITURES HOSPITALIERES INDUSTRIE
0100011575
In Commercial Distribution

  • 03661489709067 ()


  • Orthopaedic/craniofacial implantation planning software
Holter Analysis Enhanced Plus
Northeast Monitoring, Inc.
Enhanced Plus
In Commercial Distribution

  • M581NEMK1620 ()
NEMK162

  • Cardiac arrhythmia monitoring system
No Description
Gynesonics, Inc.
SW-002
In Commercial Distribution

  • 10817929020340 ()
SW-002

  • Ultrasound-guided radio-frequency ablation system software
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
No Description
ergoline GmbH
161801
In Commercial Distribution

  • 04059358001838 ()


  • Cardiopulmonary parameter spot-check measurement software
No Description
Carl Zeiss Meditec AG
5
In Commercial Distribution

  • 04049539070302 ()


  • Operating room audiovisual data/device management system
No Description
KEELER LIMITED
3020-P-5079
In Commercial Distribution

  • 05055272715744 ()


  • Ophthalmic examination slit lamp
No Description
KONICA MINOLTA, INC.
AEVM
In Commercial Distribution

  • 04560141951433 ()


  • Basic diagnostic x-ray system application software
Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF003
In Commercial Distribution

  • 00850013007417 ()
ELF003

  • Audiometric/hearing device software
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