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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
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
DiaCom software
In Commercial Distribution

  • EPTWS0200080 ()
S020008

  • Multi-modality therapeutic radiation phantom, anthropomorphic
No Description
Hologic, Inc.
System Software
In Commercial Distribution

  • 15420045504721 ()


  • Mammographic stereotactic biopsy system
No Description
Hologic, Inc.
I-View Software
In Commercial Distribution

  • 15420045512658 ()
SW-03078

  • Stationary mammographic x-ray system, digital
3DQuorum® is an image processing software application for post-processing tomosynthesis data captured on a Hologic tomosynthesis imaging system, into a combined 3D image.
Hologic, Inc.
3DQUORUM SOFTWARE
In Commercial Distribution

  • 15420045512313 ()
SW-05673

  • Stationary mammographic x-ray system, digital
Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Hologic, Inc.
3DIMENSIONS SOFTWARE
In Commercial Distribution

  • 15420045507296 ()
SW-04883

  • Stationary mammographic x-ray system, digital
IntelliVue Bispectral Index (BIS) Module M1034B for use with IntelliVue Patient Monitors MP40-MP90 and MX500-MX800. Bispectral Index (BIS) monitoring helps to monitor the level of consciousness of a patient under general anesthesia or sedation in the OR and ICU.
Philips Medizin Systeme Böblingen GmbH
IntelliVue BIS Module
In Commercial Distribution

  • 00884838051515 ()
866421

  • Patient monitoring system module, interfacing
Rapid System Update
Ischemaview, Inc.
5.102
In Commercial Distribution

  • B761R51020 ()


  • Radiological PACS software
OPTION, BISX BASE MODULE, REFURB
SPACELABS HEALTHCARE (WASHINGTON), INC
91482
In Commercial Distribution

  • 10841522108754 ()
N/A

  • Patient monitoring system module, electroencephalographic
MODULE BISX, 91482
SPACELABS HEALTHCARE (WASHINGTON), INC
Module: BISx
In Commercial Distribution

  • 10841522100253 ()
91482

  • Patient monitoring system module, electroencephalographic
BIS (TM) Advance Monitor
Covidien LP
PMB4000ACBL
In Commercial Distribution

  • 10884521808317 ()


  • Analytical scalp lead
BIS (TM) Advance Docking Station
Covidien LP
PMB4000DOC
In Commercial Distribution

  • 10884521808300 ()


  • Anaesthesia depth monitor
BIS (TM) Advance Monitor
Covidien LP
PMB4000
In Commercial Distribution

  • 10884521808270 ()


  • Anaesthesia depth monitor
SOFTWARE 9730877 ORTHO LICENSE (PLUS)
MEDTRONIC NAVIGATION, INC.
9730877
Not in Commercial Distribution

  • 00721902849787 ()


  • Multi-purpose stereotactic surgery system
SOFTWARE EXECUTABLE, LUCAS Report Generator
PHYSIO-CONTROL, INC.
60600
In Commercial Distribution

  • 00883873851913 ()
60600-000145

  • Medical equipment clinical data interfacing software
TS1200CL TELESTETH SOFTWARE HOSTED LICENSE
3M COMPANY
TS1200CL
In Commercial Distribution

  • 00707387766597 ()
TS1200CL

  • Stethoscope application software
Nexstim NBS German Main Software
Nexstim Oyj
5
In Commercial Distribution

  • 06430063200064 ()


  • Stereotactic neuronavigation/planning system
  • Hand-held deep-tissue electromagnetic stimulator
  • Electromyograph
SeeMore ViewBladder 10 Software 2.0.03
INTERSON CORP
2.0.03 ViewBladder
In Commercial Distribution

  • 00850921007134 ()
98-3518-00

  • Extracorporeal ultrasound imaging transducer, hand-held
Laboratory Information System application software
Cerner Corporation
27.2.2
Not in Commercial Distribution

  • 00853023006159 ()


  • Clinical laboratory information system application software
ClearPoint Array Software Version 1.1
Clearpoint Neuro, Inc.
CPA-SFW-11-11
In Commercial Distribution

  • 00850376007659 ()
CPA-SFW-11-11

  • Neurological stereotactic surgery system
ClearPoint Array Software Version 1.0
Clearpoint Neuro, Inc.
CPA-SFW-11-1
In Commercial Distribution

  • 00850359007744 ()
CPA-SFW-11-1

  • Neurological stereotactic surgery system
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