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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
Exo Imaging, Inc.
EW1001
In Commercial Distribution

  • 00850018318013 ()


  • Ultrasound imaging system application software
No Description
VINEHEALTH DIGITAL LIMITED
R1 V3
In Commercial Distribution

  • 05070000764122 ()


  • Clinical management support software
Software to identify heart failure patients who may be at risk of having wtATTR-CM
PFIZER INC.
CI4054279
In Commercial Distribution

  • 05415062388310 ()


  • Cardiovascular interpretive screening software
MediScout® is an augmented reality accessory to clinical ultrasound (US) systems, with the ability to holographically display the US image for the user as well as provide procedural annotation and a teleprodecural function for remote practitioner collaboration.
Mediview Xr, Inc.
MS-100-1001
In Commercial Distribution

  • 00860006066307 ()


  • Ultrasound imaging system application software
No Description
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
Scansys TA517
In Commercial Distribution

  • 06945087505175 ()


  • Eye anterior segment analyser
DynaLync Prostate
Philips DS North America LLC
784016
Not in Commercial Distribution

  • 00884838085510 ()


  • MRI system application software
HexaVue IP In-Light Camera Control Feature
BLACK DIAMOND VIDEO, INC.
HexaVue IP
In Commercial Distribution

  • 00724995220594 ()
XQHPILCC

  • Operating room audiovisual data/device management system application software
The HexaVue Surgical Camera Control OR Integration software module allows the remote control of surgical camera.
BLACK DIAMOND VIDEO, INC.
HexaVue SCC 1.0
In Commercial Distribution

  • 00724995198503 ()
XQHILCC1

  • Operating room audiovisual data/device management system application software
The IDSS Integration System with Surgical Camera Control is an integrated audio-visual system which combines monitors, medical imaging devices, lights, music, and cameras.
BLACK DIAMOND VIDEO, INC.
IDSS-SCC
Not in Commercial Distribution

  • 00724995198473 ()
XQSILCC1

  • Operating room audiovisual data/device management system application software
ARCHITECT c Systems SI Units / Alternate Units MULTIGENT Assay Disk Version 7.00
ABBOTT LABORATORIES
8K51-07
In Commercial Distribution

  • 00380740161323 ()
08K5107

  • Laboratory instrument/analyser application software IVD
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