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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Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESCRIBE-CAA-DAACA
Not in Commercial Distribution

  • 00817655020617 ()


  • Patient health record information system
ProTube is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is carried out safely and in a traceable way. ProTube is designed to support positive patient identification, order review, automatic tube recognition, automatic tube labelling, production of single labels for biological sample containers, sample check-out and monitoring of transport parameters.
Inpeco SA
PTB
In Commercial Distribution

  • 07640172343012 ()


  • Specimen information management system IVD
The ProTube System is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is carried out safely and in a traceable way. The ProTube System is designed to support positive patient identification, order review, automatic tube recognition, automatic tube labelling, production of single labels for biological sample containers and sample check-out.
Inpeco SA
PTB
In Commercial Distribution

  • 07640172343005 ()


  • Specimen information management system IVD
Opal-RAD is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPAL 02-04-06-000
In Commercial Distribution

  • 00817100020490 ()


  • Diagnostic x-ray digital imaging system workstation
Opal-RAD is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPAL 02-04-04-000
In Commercial Distribution

  • 00817100020209 ()


  • Diagnostic x-ray digital imaging system workstation
EXA is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images are not intended for diagnostic review.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
EXA 01-04-000
In Commercial Distribution

  • 00817100020193 ()


  • Diagnostic x-ray digital imaging system workstation
Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESWKST-FAA-BXXXX
Not in Commercial Distribution

  • 00812345027785 ()


  • Patient health record information system
Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESWKST-EAA-BXXXX
Not in Commercial Distribution

  • 00812345027778 ()


  • Patient health record information system
Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESCRIBE-CAA-CXACB
Not in Commercial Distribution

  • 00812345027761 ()


  • Patient health record information system
Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESCRIBE-CAA-FAACB
Not in Commercial Distribution

  • 00812345027754 ()


  • Patient health record information system
Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESCRIBE-CAA-CXXXX
Not in Commercial Distribution

  • 00812345027747 ()


  • Patient health record information system
Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESCRIBE-AAB-CXXXA
Not in Commercial Distribution

  • 00812345027730 ()


  • Patient health record information system
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-010-51
In Commercial Distribution

  • 00812345025217 ()


  • Patient health record information system
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-010-50
In Commercial Distribution

  • 00812345023459 ()


  • Patient health record information system
No Description
HiCat GmbH
6543651
In Commercial Distribution

  • B06965436510 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Extension, Table Array
Nuvasive, Inc.
8230042
In Commercial Distribution

  • 00887517976062 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay CE Table Array Set
Nuvasive, Inc.
LRTABLELOANCE
In Commercial Distribution

  • 00887517996022 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Image Enhancement Sys Computer
Nuvasive, Inc.
8230045
In Commercial Distribution

  • 00887517994820 ()


  • Diagnostic x-ray digital imaging system workstation
Lessray Touchscreen Monitor
Nuvasive, Inc.
8230044
In Commercial Distribution

  • 00887517994813 ()


  • Diagnostic x-ray digital imaging system workstation
Lessray PAL to NTSC Converter Assembly
Nuvasive, Inc.
8230043
In Commercial Distribution

  • 00887517994806 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Keyboard, iKey
Nuvasive, Inc.
1675899
In Commercial Distribution

  • 00887517992789 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Remote, Wired
Nuvasive, Inc.
8230022
In Commercial Distribution

  • 00887517805997 ()


  • Diagnostic x-ray digital imaging system workstation
Exalis is an integrated product able to acquire, process and supply data required when running a dialysis treatment. This software application makes it possible to insert, modify, acquire, display in textual and graphical form data about dialysis prescription, ongoing and performed dialysis treatments and patient personal data
GAMBRO DASCO SPA
113297
Not in Commercial Distribution

  • 07332414106126 ()
113297

  • Patient health record information system
Exalis is an integrated product able to acquire, process and supply data required when running a dialysis treatment. This software application makes it possible to insert, modify, acquire, display in textual and graphical form data about dialysis prescription, ongoing and performed dialysis treatments and patient personal data.
GAMBRO DASCO SPA
6041909
Not in Commercial Distribution

  • 07332414106119 ()
6041909

  • Patient health record information system
LessRay Monitor & Bracket, 15.6" Touch
Nuvasive, Inc.
8230007
In Commercial Distribution

  • 00887517732729 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Monitor and Bracket, 27"
Nuvasive, Inc.
8230006
In Commercial Distribution

  • 00887517732712 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Computer Enclosure
Nuvasive, Inc.
8230004
In Commercial Distribution

  • 00887517732699 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Cart
Nuvasive, Inc.
8230002
In Commercial Distribution

  • 00887517732675 ()


  • Diagnostic x-ray digital imaging system workstation
The FFRangio System is a non invasive image based software device
CATHWORKS LTD
FAU04000
In Commercial Distribution

  • 17290017855056 ()
  • 07290017855059 ()
FAU04000

  • Diagnostic x-ray digital imaging system workstation
The FFRangio™ System, manufactured by CathWorks Ltd., is a non-invasive image-‎based software ‎device that provides physicians with a quantitative analysis of ‎functional significance of a coronary ‎lesion, similar to invasive FFR (Fractional Flow ‎Reserve), and a qualitative three-dimensional model of ‎the demonstrated coronary ‎arteries, during routine PCI procedure. The FFRangio™ System performs ‎all required ‎processing and calculations based only on angiography images and hemodynamics ‎‎information that are acquired during the coronary catheterization procedure.‎
CATHWORKS LTD
FAU01000
In Commercial Distribution

  • 17290017855025 ()
  • 07290017855028 ()
FAU01000

  • Diagnostic x-ray digital imaging system workstation
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