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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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UIMS Viewing Station
Dornier MedTech GmbH
UIMS
In Commercial Distribution

  • 04049957000554 ()
K1028986

  • Basic diagnostic x-ray system operation software
StrokeSENS LVO is a radiological computer-aided triage and notification software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) in head CTA images.
Circle Neurovascular Imaging Inc
v1.x
In Commercial Distribution

  • B926SSSX10 ()


  • CT system application software
The seca 115 PC software is for administering weight, height, bioimpedance and vital measurements and for calculating automatically parameters such as FMI (fat mass index) which can be derived from these measurements. Results are displayed in graphical form and provide support with the following medical issues: • Documentation of weight changes • Documentation of energy expenditure and energy reserves • Documentation of cardiometabolic risk • Documentation of metabolic activity and the success of a training program, e.g. within the framework of rehabilitation or physiotherapy • Documentation of a patient’s fluids status and documentation of changes in fluids • Documentation of changes in vital signs
seca GmbH & Co. KG
115
Not in Commercial Distribution

  • 04012030013406 ()
1151300010

  • Medical equipment clinical data interfacing software
The seca 115 PC software is for administering weight, height, bioimpedance and vital measurements and for calculating automatically parameters such as FMI (fat mass index) which can be derived from these measurements. Results are displayed in graphical form and provide support with the following medical issues: • Documentation of weight changes • Documentation of energy expenditure and energy reserves • Documentation of cardiometabolic risk • Documentation of metabolic activity and the success of a training program, e.g. within the framework of rehabilitation or physiotherapy • Documentation of a patient’s fluids status and documentation of changes in fluids • Documentation of changes in vital signs
seca GmbH & Co. KG
115
Not in Commercial Distribution

  • 04012030013383 ()
1151306010

  • Medical equipment clinical data interfacing software
The seca 115 PC software is for administering weight, height, bioimpedance and vital measurements and for calculating automatically parameters such as FMI (fat mass index) which can be derived from these measurements. Results are displayed in graphical form and provide support with the following medical issues: • Documentation of weight changes • Documentation of energy expenditure and energy reserves • Documentation of cardiometabolic risk • Documentation of metabolic activity and the success of a training program, e.g. within the framework of rehabilitation or physiotherapy • Documentation of a patient’s fluids status and documentation of changes in fluids • Documentation of changes in vital signs
seca GmbH & Co. KG
115
Not in Commercial Distribution

  • 04012030013376 ()
1151303010

  • Medical equipment clinical data interfacing software
The Maestro System is intended to hold and position laparoscopes and laparoscopic instruments during laparoscopic surgical procedures.
Moon Surgical Inc
100
In Commercial Distribution

  • 03770025849096 ()


  • Surgical camera holder
No Description
MILVUE
V2.x.x
In Commercial Distribution

  • 03770024774016 ()


  • X-ray image interpretive software
Vital Sync Weaning Readiness and Spontaneous Breathing Trial Monitoring Application v1 Software with OUS Support
Covidien LP
WRSBTSW01
In Commercial Distribution

  • 10884521762633 ()


  • Multiparameter physiologic analysis workstation
Vital Sync Early Warning Score Application v1 Software with OUS Support
Covidien LP
EWSSW01
In Commercial Distribution

  • 10884521762626 ()


  • Multiparameter physiologic analysis workstation
StrokeViewer LVO Triaging is a notification only cloud-based image processing software application using artificial intelligence algorithms to analyze patient imaging data in parallel to the standard of care imaging interpretation.
NICo-Lab B.V.
3
In Commercial Distribution

  • 08720299502338 ()


  • X-ray image interpretive software
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