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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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SureTune™ 4 - 00763000990428

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

  • 00763000990428 ()


  • Implantable electrical stimulation device management software

OrthoNext™ Platform System Software - 18059015375848

POSTOPERATIVE TLHEXMODULE VERSION 1.1 FOR ORTHONEXT SOFTWARE
ORTHOFIX SRL
1.1
In Commercial Distribution

  • 18059015375848 ()
TLHEXMODULESW1.1

  • Radiological PACS software

OrthoNext™ Platform System Software - 18053340345682

PREOPERATIVE JPS MODULE FOR ORTHONEXT SOFTWARE
ORTHOFIX SRL
1.1
In Commercial Distribution

  • 18053340345682 ()
JPSMODULESW

  • Radiological PACS software

OrthoNext™ Platform System Software - 18052469470008

PREOPERATIVE FITBONE MODULE FOR ORTHONEXT SOFTWARE
ORTHOFIX SRL
1.0
In Commercial Distribution

  • 18052469470008 ()
FITBONEMODULESW

  • Radiological PACS software

FTM-EVAL-AA - 03760349820062

FeetMe Evaluation mobileAndroid application version 3.Y.Z.
FEETME
3
In Commercial Distribution

  • 03760349820062 ()


  • Posturography system application software

Kinesis Balance - 05391542950027

Kinesis Balance is a smartphone application for assessment of balance and falls risk in older adults. The product is software based and uses simple clinical questionnaires and the sensors embedded in a smartphone to measure balance and assess risk of falls. The application is intended to be used by older adults and their carers in the home.
KINESIS
2.0.1
In Commercial Distribution

  • 05391542950027 ()


  • Posturography system application software

Assess Balance - 00860010129111

No Description
Balance Tracking Systems Incorporated
Version 7
In Commercial Distribution

  • 00860010129111 ()


  • Posturography system application software

BriefCase Triage - 07290018052297

BriefCase is a radiological computer aided triage and notification software
AIDOC MEDICAL LTD
23.y.z
In Commercial Distribution

  • 07290018052297 ()


  • Radiology DICOM image processing application software

BriefCase Triage - 07290018052273

BriefCase is a radiological computer aided triage and notification software
AIDOC MEDICAL LTD
22.y.z
In Commercial Distribution

  • 07290018052273 ()


  • Radiology DICOM image processing application software

BriefCase Triage - 07290018052259

BriefCase is a radiological computer aided triage and notification software
AIDOC MEDICAL LTD
21.x.y
In Commercial Distribution

  • 07290018052259 ()


  • Radiology DICOM image processing application software
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