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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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ECG 2.0 App - 00190199649293

ECG iPhone App (version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution

  • 00190199649293 ()


  • Cardiopulmonary physiological parameter analysis software

ECG App - 00190198909541

No Description
APPLE INC.
Feature Version 1.x
In Commercial Distribution

  • 00190198909541 ()


  • Cardiopulmonary physiological parameter analysis software

ECG 2.0 App - 00190199649286

ECG Watch App (version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution

  • 00190199649286 ()


  • Cardiopulmonary physiological parameter analysis software

ECG App - 00190198909534

No Description
APPLE INC.
Feature Version 1.x
In Commercial Distribution

  • 00190198909534 ()


  • Cardiopulmonary physiological parameter analysis software

TeraRecon Aorta.CT - AORTACT01

TeraRecon Aorta.CT is intended to provide an automatic 3D segmentation and label anatomical landmarks of the Aorta. The results of TeraRecon Aorta.CT are intended to be used in conjunction with other patient information by trained professionals who are responsible for making any patient management decision per the standard of care.
Terarecon Inc.
Aorta.CT01
In Commercial Distribution

  • AORTACT01 ()
Aorta.CT

  • Radiology DICOM image processing application software

Change Healthcare Anatomical AI™ - 17540262150018

No Description
Change Healthcare Canada Company
1.0.0
In Commercial Distribution

  • 17540262150018 ()


  • Radiological PACS software

SureTune™ 4 - 00763000496456

SW B36104S SURETUNE4 DBS SERVER
MEDTRONIC, INC.
B36104S
In Commercial Distribution

  • 00763000421212 ()
  • 00763000496456 ()


  • Implantable electrical stimulation device management software

SureTune™ 4 - 00763000496449

SW B36104C SURETUNE4 DBS CLIENT
MEDTRONIC, INC.
B36104C
In Commercial Distribution

  • 00763000421212 ()
  • 00763000496449 ()


  • Implantable electrical stimulation device management software

SureTune™ 4 - 00763000496432

SW B36104A SURETUNE4 DBS STANDALONE
MEDTRONIC, INC.
B36104A
In Commercial Distribution

  • 00763000421212 ()
  • 00763000496432 ()


  • Implantable electrical stimulation device management software

QLAB Advanced Quantification Software - 00884838115323

No Description
Philips Ultrasound LLC
Release 15.6
In Commercial Distribution

  • 00884838115323 ()
795041

  • Radiological PACS software
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