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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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CAS-One IR Software - 07616962000250

No Description
CAScination AG
4.1
In Commercial Distribution

  • 07616962000250 ()
20016

  • Radiology picture archiving and communication system workstation

U400 ImpSoft Software - B277292U400CD0

Impsoft data management & analysis software
IMPEDIMED LIMITED
2.2.0
In Commercial Distribution

  • B277292U400CD2 ()
  • B277292U400CD1 ()
  • B277292U400CD0 ()
292-U400CD

  • Bioelectrical body composition analyser

Cranial Guidance Software - 07613327538410

Cranial Guidance Enable
Stryker Leibinger GmbH & Co. KG
6000-670-300
In Commercial Distribution

  • 07613327538410 ()
6000-670-300

  • Electromagnetic/optical surgical navigation device tracking system

Cranial Guidance Software - 07613327538328

Cranial Guidance Sales Demo
Stryker Leibinger GmbH & Co. KG
81-81042
In Commercial Distribution

  • 07613327538328 ()
81-81042

  • Electromagnetic/optical surgical navigation device tracking system

tremoFlo US Software - 07540261013454

tremoFlo Airwave Oscillometry System software component (US Version). System to measure respiratory system impedance using the Forced Oscillation Technique (FOT).
Thorasys Thoracic Medical Systems Inc
101345
In Commercial Distribution

  • 07540261013454 ()


  • Pulmonary function analysis system, adult

Dental Imaging Software - 60889971045072

Dental Imaging software update only
CARESTREAM HEALTH, INC.
Dental Imaging Software
In Commercial Distribution

  • 60889971045072 ()
1045079

  • General-purpose dental x-ray system application software

ROSA Hip Software - 00887868525681

No Description
Orthosoft Inc
20-8060-400-01
In Commercial Distribution

  • 00887868525681 ()
20-8060-400-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable

VERASENSE Software Application - 07613327581843

No Description
ORTHOSENSOR INC
5.6.1.138
Not in Commercial Distribution

  • 07613327581843 ()
05000-VRSE

  • Arthroplasty force sensor display unit

Biograph Infiniti Software - 07540191000449

No Description
Thought Technology Ltd.
SA7900
In Commercial Distribution

  • 07540191000449 ()


  • Psychophysiological biofeedback system

ICUpilot Software eng - 07332699000751

No Description
M DIALYSIS INC.
English
In Commercial Distribution

  • 07332699000751 ()
8001027

  • Bedside information system
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