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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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Intelligent Endoscopy Module
Covidien LP
CB1708-EU
In Commercial Distribution

  • 10884521807259 ()

  • Voltage, 100- 240, VAC;+/-10%,50/60,Hertz;Power,240,W;


  • Endoscopic video image interpretive unit
SW B36104S SURETUNE4 DBS SERVER MDR
MEDTRONIC, INC.
B36104S
In Commercial Distribution

  • 00763000990442 ()


  • Implantable electrical stimulation device management software
SW B36104C SURETUNE4 DBS CLIENT MDR
MEDTRONIC, INC.
B36104C
In Commercial Distribution

  • 00763000990435 ()


  • Implantable electrical stimulation device management software
SW B36104A SURETUNE4 DBS STANDALONE MDR
MEDTRONIC, INC.
B36104A
In Commercial Distribution

  • 00763000990428 ()


  • Implantable electrical stimulation device management software
POSTOPERATIVE TLHEXMODULE VERSION 1.1 FOR ORTHONEXT SOFTWARE
ORTHOFIX SRL
1.1
In Commercial Distribution

  • 18059015375848 ()
TLHEXMODULESW1.1

  • Radiological PACS software
PREOPERATIVE JPS MODULE FOR ORTHONEXT SOFTWARE
ORTHOFIX SRL
1.1
In Commercial Distribution

  • 18053340345682 ()
JPSMODULESW

  • Radiological PACS software
PREOPERATIVE FITBONE MODULE FOR ORTHONEXT SOFTWARE
ORTHOFIX SRL
1.0
In Commercial Distribution

  • 18052469470008 ()
FITBONEMODULESW

  • Radiological PACS software
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
No Description
Balance Tracking Systems Incorporated
Version 7
In Commercial Distribution

  • 00860010129111 ()


  • Posturography system application software
FeetMe Evaluation mobileAndroid application version 3.Y.Z.
FEETME
3
In Commercial Distribution

  • 03760349820062 ()


  • Posturography system application software
Software for use in the review, annotation and analysis of patient data collected using external physiological monitors.
MOBERG RESEARCH INC
VIS-100
In Commercial Distribution

  • B485VIS100 ()


  • Bioelectrical signal analysis software
Software for use in the review, annotation and analysis of patient data collected using external physiological monitors.
NATUS NEUROLOGY INCORPORATED
1.03.00
In Commercial Distribution

  • B485CNSENV1000 ()


  • Bioelectrical signal analysis software
software versions 3.6.0, 3.7.0, 3.7.1, 3.8.0, 3.9.0 Annalise Triage (Annalise Critical Care AI) is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
3.6.0+
In Commercial Distribution

  • G140ANNALISEENTP50 ()
AnnaliseENTP5

  • X-ray image interpretive software
Annalise Triage is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
3.4.1
In Commercial Distribution

  • G140ANNALISEENTP40 ()


  • Radiology DICOM image processing application software
Annalise Enterprise is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
3.3.0
In Commercial Distribution

  • G140ANNALISEENTP30 ()


  • Radiology DICOM image processing application software
Annalise Enterprise is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
3.2.0
In Commercial Distribution

  • G140ANNALISEENTP20 ()


  • Radiology DICOM image processing application software
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 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 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
BriefCase is a radiological computer aided triage and notification software
AIDOC MEDICAL LTD
19.x.y
In Commercial Distribution

  • 07290018052211 ()


  • Radiology DICOM image processing application software
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