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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 - 00763000990442

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

  • 00763000990442 ()


  • Implantable electrical stimulation device management software

SureTune™ 4 - 00763000990435

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

  • 00763000990435 ()


  • Implantable electrical stimulation device management software

SureTune™ 4 - 00763000990428

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

  • 00763000990428 ()


  • Implantable electrical stimulation device management 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

Radixact®, Treatment Delivery Console (TDC) - M65810577270

Software, Version 1.0.0.4, Treatment Delivery Console, Radixact (Operating Software for Radixact Treatment Delivery System)
ACCURAY INCORPORATED
1057727
In Commercial Distribution

  • M65810577270 ()
NA

  • Linear accelerator system

VITEK®2 - 03573026555504

VITEK®2 software 9.01.0, advanced software to run your VITEK®2 system
BIOMERIEUX , INC.
9.01.0
Not in Commercial Distribution

  • 03573026555504 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD

360CAS - B432360CAS2200

360CAS Navigation System Software is a bespoke software developed by Kico for surgical navigation.
KICO KNEE INNOVATION COMPANY PTY LIMITED
2.2.0
In Commercial Distribution

  • B432360CAS2200 ()


  • Robotic surgical navigation system application software

Annalise Triage - G140ANNALISEENTP50

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
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