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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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BriefCase-Quantification is an Automated Radiological Image Processing Software.
AIDOC MEDICAL LTD
BC.QTF.3.x.y
In Commercial Distribution

  • 07290018052235 ()


  • Radiology DICOM image processing application software
POSTOPERATIVE TLHEXMODULE VERSION 1.1 FOR ORTHONEXT SOFTWARE
ORTHOFIX SRL
1.1
In Commercial Distribution

  • 18059015375848 ()
TLHEXMODULESW1.1

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

  • 00860010129111 ()


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

  • 03760349820062 ()


  • Posturography system application software
Visix software for use with just an intraoral camera version 2.3.10
TELEVERE SYSTEMS, LLC
for Intraoral Camera 2.3.10
In Commercial Distribution

  • 00851800007092 ()
Visix for Intraoral Camera 2.3.10

  • Camera application software
  • Radiological PACS software
No Description
VARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED
2.3
In Commercial Distribution

  • 00856104006123 ()


  • Radiation therapy treatment record/verify system
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