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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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BL HEALTHCARE, INC.
3.0
In Commercial Distribution

  • 00863353000307 ()


  • Home healthcare information system
UroNAV 1.x to 2.0 Upgrade
Philips DS North America LLC
784011
In Commercial Distribution

  • 00884838066991 ()


  • Stereotactic system application software
Software medical device. Intended for use by professional healthcare providers as an intra-operative image-guidance tool used during surgical and interventional therapy.
Philips Medical Systems Nederland B.V.
ClarifEye - 1
In Commercial Distribution

  • 00884838104570 ()
002120

  • Stereotactic system application software
IntelliSpace Perinatal Large Architecture is a software-only offering and includes three separate versions of IntelliSpace Perinatal.
Philips Medical Systems Hsg
IntelliSpace Perinatal K Large Arch.
In Commercial Distribution

  • 00884838084483 ()
867061

  • Obstetrics information system
UroNAV Fusion Biopsy System
Philips DS North America LLC
784001
In Commercial Distribution

  • 00884838083592 ()


  • Stereotactic system application software
UroNav Fusion Biopsy Software
Philips DS North America LLC
784015
In Commercial Distribution

  • 00884838081550 ()


  • Stereotactic system application software
UroNAV Fusion Biopsy System
Philips DS North America LLC
784012
In Commercial Distribution

  • 00884838081543 ()


  • Stereotactic system application software
Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCREV-AAA-BXXXX
Not in Commercial Distribution

  • 00812345028140 ()


  • Cardiology information system
Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCREV-AAA-BXXAX
Not in Commercial Distribution

  • 00812345028133 ()


  • Cardiology information system
No Description
THINK SURGICAL, INC.
109000
In Commercial Distribution

  • M9461090000 ()
109000

  • Stereotactic system application software
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