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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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No Description
Brainlab AG
3.0
Not in Commercial Distribution

  • 04056481138790 ()
26615-01

  • Robotic surgical navigation system
No Description
Brainlab AG
3.0
Not in Commercial Distribution

  • 04056481138783 ()
26614-01

  • Robotic surgical navigation system
syngo Application Software VE3
Siemens Healthcare GmbH
30000266
In Commercial Distribution

  • 04056869964546 ()


  • Basic diagnostic x-ray system application software
syngo Application Software VE4
Siemens Healthcare GmbH
30000267
In Commercial Distribution

  • 04056869964539 ()


  • Basic diagnostic x-ray system application 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
syngo Application Software VD2
Siemens Healthcare GmbH
10849231
In Commercial Distribution

  • 04056869050874 ()


  • Basic diagnostic x-ray system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10855671
Not in Commercial Distribution

  • 04056869001067 ()


  • Radiological PACS software
No Description
KONICA MINOLTA, INC.
AEVM
In Commercial Distribution

  • 04560141951433 ()


  • Basic diagnostic x-ray system application software
Care Orchestrator Clinical Management Data Software
Respironics, Inc.
1.13
In Commercial Distribution

  • 00606959050730 ()
1126366

  • Medical equipment clinical data interfacing software
Software version for Amicus Separator
Fresenius Kabi AG
6.0
In Commercial Distribution

  • 04086000101912 ()


  • Apheresis system
Software version for Amicus Separator.
Fresenius Kabi AG
5.12
In Commercial Distribution

  • 04086000101660 ()


  • Apheresis system
Software version for Amicus Separator.
Fresenius Kabi AG
5.121
In Commercial Distribution

  • 04086000101653 ()


  • Apheresis system
Software version for Aurora Xi.
Fresenius Kabi AG
1.1
In Commercial Distribution

  • 04086000101516 ()


  • Apheresis system
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
MapRT is used to assist treatment planning whereby the patient surface and positioning devices captured at simulation can be modelled against the treatment devices, such that any potential collisions can be predicted.
VISION RT LIMITED
MapRT acquisition software
In Commercial Distribution

  • 05056190500757 ()
MapRT

  • Radiation therapy software
AlignRT 7.3 (software) used on AlignRT Plus systems
VISION RT LIMITED
AlignRT 7.3 (software)
In Commercial Distribution

  • 05056190500726 ()
AlignRT 7.3 (software)

  • Radiological video camera patient positioning/tracking system
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
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2188
In Commercial Distribution

  • 14953170373760 ()
  • 04953170373763 ()
N5400340

  • Video capsule endoscopy system application software
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