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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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Natus Quantum Amplifier system – 64 channels (phase II)
XLTEK
PK1258
In Commercial Distribution

  • 00382830048453 ()


  • Electroencephalograph
Mayo Dissecting Scissors Classic Round Blades Straight Quantum
SONTEC INSTRUMENTS, INC.
1100-249Q
In Commercial Distribution

  • 00192896121928 ()

  • Length: 6 Inch
1100-249Q

  • General-purpose surgical scissors, reusable
software versions 3.10+ Annalise Critical Care AI is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
3.10.0+
In Commercial Distribution

  • G140ANNALISEENTP60 ()
AnnaliseENTP6

  • X-ray image interpretive software
  • Radiology DICOM image processing application software
Software and sensor to provide assessment of respiratory capabilities.
ACCELERATED CARE PLUS CORP
ARASoftware
In Commercial Distribution

  • 00858703006344 ()


  • Pulmonary function analysis software, interpretive
  • Diagnostic spirometer, professional
No Description
Icad, Inc.
V2
Not in Commercial Distribution

  • 00858012005939 ()


  • Basic diagnostic x-ray system application software
No Description
RAPID Biomedical GmbH
10185782 02
In Commercial Distribution

  • 04260487680041 ()


  • MRI system coil, radio-frequency
No Description
Change Healthcare Canada Company
1.0.0
In Commercial Distribution

  • 17540262150018 ()


  • Radiological PACS software
Eureka AI Results Explorer (aka Northstar AI Results Explorer and Northstar) is a zero-footprint, web-based software device indicated for use in clinical settings where medical images and image-derived metadata can be accessed or visualized to aid healthcare professionals in diagnosis and patient management decision making. Eureka AI Results Explorer’s web interfaces can obtain and consume both DICOM and non-DICOM image-derived metadata generated by Artificial Intelligence (AI) or computer vision algorithms.
Terarecon Inc.
Eureka AI Results Explorer
In Commercial Distribution

  • B2208430011 ()


  • Radiology DICOM image processing application software
OrthoGrid Trauma AI for non-invasive software system that provides image analysis tools for trauma procedures
Orthogrid Systems, Inc.
2010-915-507
In Commercial Distribution

  • 00860003424841 ()


  • Orthopaedic fluoroscopic grid software
BEIGE/990011-SWH; set of Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990011-SWH
In Commercial Distribution

  • 00850016231116 ()


  • Air-conduction hearing aid, receiver-in-canal
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