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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
Megagen Implant Co. Ltd
KAISS3000
In Commercial Distribution

  • 08806388286225 ()
KAISS3000

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
No Description
FCU
SC1
In Commercial Distribution

  • 08800076600157 ()


  • Hand-held ultrasound imaging system, body-surface
No Description
Icad, Inc.
3.1
In Commercial Distribution

  • 00850008977275 ()


  • Radiology DICOM image processing application software
No Description
Icad, Inc.
3.1
In Commercial Distribution

  • 00850008977268 ()


  • Radiology DICOM image processing application software
No Description
Icad, Inc.
3.0
In Commercial Distribution

  • 00850008977176 ()


  • Basic diagnostic x-ray system application software
Genius AI® is a computer-aided detection and diagnosis (CADe/CADx) software device intended to be used with compatible digital breast tomosynthsis (DBT) systems to identify and mark regions of interest including soft tissue densities (masses, architectural distortions, and assymetries) and calcifications in DBT exams from compatible DBT systems and provide confidence scores that offer assessment for Certainty of Findings and a Case Score.
Hologic, Inc.
GENIUS AI DETECTION SOFTWARE
In Commercial Distribution

  • 15420045512474 ()
ASY-15431

  • Stationary mammographic x-ray system, digital
The Momentum Spine app is an optical contour sensing mobile application intended to quantify asymmetries, assess body angles and curve progression related to postural asymmetries, including scoliosis. The device is available directly to lay users (Over-the-Counter) and may also be prescribed for use by physicians. The device is intended for use in patients 8 years and older.
Momentum Health Inc
Momentum Spine
In Commercial Distribution

  • 00628774533007 ()


  • Posture imaging/analysis software
Quantum Data Management Unit
SPECTRUM MEDICAL LIMITED
QDMU
Not in Commercial Distribution

  • 05060434420039 ()
3008-001-010

  • Patient health record information system
Quantum E Micro CIC
Unitron Hearing Ltd
063-5634-01
In Commercial Distribution

  • 00698764455848 ()
063-5634-01

  • Air-conduction hearing aid, canal
Quantum E 312 Dir
Unitron Hearing Ltd
063-5630-01
In Commercial Distribution

  • 00698764455800 ()
063-5630-01

  • Air-conduction hearing aid, canal
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