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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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No Description
Dentaleye AB
PRO
In Commercial Distribution

  • 07350111570019 ()


  • Radiological PACS software
No Description
Qbtech AB
QbTest
In Commercial Distribution

  • 07350103930067 ()


  • Psychological assessment software
No Description
Qbtech AB
QbCheck
In Commercial Distribution

  • 07350103930012 ()


  • Psychological assessment software
MRI Planner is a stand alone software product intended to enable a completely MRI only workflow in radiotherapy planning. The MRI Planner software achieves this by analyzing a dedicated MR image and generating a synthetic CT image that can replace the conventional CT in the treatment planning process. In addition, the software also performs automated contouring of risk organs in certain anatomies. In the current version of MRI Planner, synthetic CT generation is supported for the brain, head-neck and pelvis anatomies, whereas automated risk organ contouring is supported for bladder, colon and femoral heads for prostate cancer patients only.
Spectronic Medical AB
2
In Commercial Distribution

  • 07350097430017 ()


  • Radiation therapy software
reSET-O is intended to increase retention of patients with Opioid Use Disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic. This configuration of reSET-O is intended to provide virtual incentives to patients based on the Contingency management system.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10196439000036 ()
N/A

  • Psychological assessment software
reSET-O is intended to increase retention of patients with Opioid Use Disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic. This configuration of reSET-O is intended to provide virtual incentives as well as monetary incentives to the patients based on the Contingency management system.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10196439000029 ()
N/A

  • Psychological assessment software
reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12-week (90 days) prescriptiononly treatment for patients with Substance Use Disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to: increase abstinence from a patient’s substances of abuse during treatment, and increase retention in the outpatient treatment program This configuration of reSET is intended to provide virtual incentives to patients based on the Contingency management system.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10196439000012 ()
N/A

  • Psychological assessment software
reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12-week (90 days) prescriptiononly treatment for patients with Substance Use Disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to: increase abstinence from a patient’s substances of abuse during treatment, and increase retention in the outpatient treatment program. This configuration of reSET is intended to provide virtual incentives as well as monetary incentives to the patients based on the Contingency management system.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10196439000005 ()
N/A

  • Psychological assessment software
No Description
Imeka Solutions Inc
1
In Commercial Distribution

  • 00754016387111 ()


  • Radiological PACS software
POSTOPERATIVE MOBILE PATIENT APPLICATION SW
ORTHOFIX SRL
1.0
In Commercial Distribution

  • 18052469476451 ()
MYHEXPLANSW

  • Radiological PACS software
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