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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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PeriWatch Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks.
PERIGEN SOLUTIONS LTD
02.08.xx
In Commercial Distribution

  • B087CURV02081 ()


  • Obstetrical monitoring/analysis software
PeriCALM Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks.
PERIGEN SOLUTIONS LTD
02.06.00
In Commercial Distribution

  • B087CURV02061 ()


  • Obstetrical monitoring/analysis software
No Description
Neurovision Medical Products, Inc.
NONE
In Commercial Distribution

  • B006EMGVIEW0 ()


  • Bioelectrical signal analysis software
No Description
Medviso AB
1
In Commercial Distribution

  • 07350010100041 ()


  • Image segmentation application software
Leksell GammaPlan
Elekta Solutions AB
1567714
In Commercial Distribution

  • 07340201502136 ()


  • Stereotactic system application software
Leksell GammaPlan
Elekta Instrument AB
1551287
In Commercial Distribution

  • 07340048311878 ()


  • Stereotactic system application software
LGP 11.1
Elekta Instrument AB
1529980
In Commercial Distribution

  • 07340048311236 ()


  • Stereotactic system application software
LGP 11.1 SW MEDIA
Elekta Instrument AB
1529604
Not in Commercial Distribution

  • 07340048311229 ()
1529980

  • Stereotactic system application software
The VRET-910 "Expose" is a prescription-only medical software used as a tool by Licensed Healthcare Provider (LHP) in order to immerse their patients into virtual reality (VR) and 360 degree simulated environments, as part of remote or in-person therapy sessions devised to improve certain mental health conditions. The software can be used in clinical settings or at home, with or without the assistance of a licensed healthcare provider.
XR HEALTH IL LTD
VRET-910 (Expose)
In Commercial Distribution

  • 07290016986167 ()


  • Hypnotherapy virtual reality software
The PD-810 ("Mindset") is intended to assist in relaxation and self-management of pain and physical discomfort through distraction and supporting meditation and relaxation exercises, performed in a virtual reality (VR) environment using commercially available VR headsets. The PD-810 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. The PD-810 provides VR exercises and takes measurements which enables the patient and/or clinician to monitor changes over time.
XR HEALTH IL LTD
PD-810 (Mindset)
In Commercial Distribution

  • 07290016986136 ()
VRReliever PD-810

  • Hypnotherapy virtual reality software
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