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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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KIT, QUANTUM ULTIMATE INTENSIVE RESUSCITATION CARRY (Q.U.I.C.K.) - BASIC
NORTH AMERICAN RESCUE, LLC
35-0026
In Commercial Distribution

  • 00842209125159 ()
35-0026

  • Conduction blood/fluid warmer
  • First aid kit, non-medicated, single-use
Natus Quantum Amplifier system – 64 channels (phase II)
XLTEK
PK1258
In Commercial Distribution

  • 00382830048453 ()


  • Electroencephalograph
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
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
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
GREY/990002-SWH; set of Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990002-SWH
In Commercial Distribution

  • 00850016231024 ()


  • Air-conduction hearing aid, receiver-in-canal
Salmonella O Polyvalent A-I Kit Group: A, B, C, D, E, F, G, H, I
PRO-LAB, INCORPORATED
PLA003
In Commercial Distribution

  • 00817978020004 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent
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