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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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Xoran Workstation is an image processing and viewing software for use with compatible radiographic data. The workstation software provides tools for image processing, viewing, interpretation, annotation, clinical review, analysis, distribution, archival, printing, and administrative reporting by healthcare professionals.
XORAN TECHNOLOGIES LLC
v5.15.5
In Commercial Distribution

  • 00860290000391 ()


  • Diagnostic x-ray digital imaging system workstation application software
No Description
XORAN TECHNOLOGIES LLC
v.6
In Commercial Distribution

  • 00860290000384 ()


  • Diagnostic x-ray digital imaging system workstation application software
No Description
XORAN TECHNOLOGIES LLC
5.2
In Commercial Distribution

  • 00860290000322 ()


  • Diagnostic x-ray digital imaging system workstation application software
MamaLift Plus is a digital therapy designed to treat symptoms of postpartum depression by delivering evidence-based therapeutic components of Cognitive Behavioral Therapy via software on a mobile application, such as a smartphone or tablet.
Curio Digital Therapeutics Inc.
MamaLift Plus
In Commercial Distribution

  • 00860012970308 ()


  • Mental health/function therapeutic software, screen-viewed
Tempus ECG-AF is a cardiovascular machine learning-based notification software intended to analyze recordings of 12-lead ECG devices from patients 65 years of age and older. The software employs machine learning techniques to analyze ECG recordings and detect signs associated with a patient experiencing atrial fibrillation and/or atrial flutter (collectively referred to as AF) within the next 12 months. The device is designed to extract otherwise unavailable information from ECGs conducted under the standard of care, to help health care providers better identify patients who may be at risk for undiagnosed AF in order to evaluate them for referral of further diagnostic follow up and address the unmet need of reducing the number of undiagnosed AF patients.
Tempus AI, Inc.
3
In Commercial Distribution

  • 00860011843603 ()


  • Cardiopulmonary physiological parameter analysis software
DIGITAL WRIST BLOOD PRESSURE MONITOR
KONQUEST GROUP INC
KBP-2910W
In Commercial Distribution

  • 00869378000445 ()


  • Patient monitoring system module, blood pressure, noninvasive
DIGITAL ARM BLOOD PRESSURE MONITOR
KONQUEST GROUP INC
KBP-2704A
In Commercial Distribution

  • 00869378000438 ()


  • Patient monitoring system module, blood pressure, noninvasive
No Description
Auditdata A/S
UNITY 4 PROBE MIC US PACKAGE
In Commercial Distribution

  • 05711781003818 ()
21031179

  • Audiometric/hearing aid tester
UNITY 4 INSITU PACKAGE
Ws Audiology Usa, Inc.
UNITY 4
In Commercial Distribution

  • 05711781003160 ()
21031181

  • Audiometric/hearing aid tester
UNITY 4 AUD + REM US PACKAGE
Ws Audiology Usa, Inc.
UNITY 4
In Commercial Distribution

  • 05711781003153 ()
21031184

  • Audiometric/hearing aid tester
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