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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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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
No Description
SCC SOFT COMPUTER
25.6.1.2
In Commercial Distribution

  • 00810055815647 ()


  • Blood bank information system application software
No Description
SCC SOFT COMPUTER
1.0.0.20
In Commercial Distribution

  • 00810055815302 ()


  • Bedside information system application software
No Description
SCC SOFT COMPUTER
25.5.6.4
In Commercial Distribution

  • 00810055814503 ()


  • Blood bank information system application software
No Description
SCC SOFT COMPUTER
4.5.5.1
In Commercial Distribution

  • 00810055814152 ()


  • Blood bank information system application software
No Description
SCC SOFT COMPUTER
1.0.0.19
In Commercial Distribution

  • 00810055814145 ()


  • Bedside information system application software
No Description
SCC SOFT COMPUTER
25.5.6.3
In Commercial Distribution

  • 00810055813667 ()


  • Blood bank information system application software
No Description
SCC SOFT COMPUTER
4.5.4.2
In Commercial Distribution

  • 00810055813650 ()


  • Blood bank information system application software
No Description
SCC SOFT COMPUTER
25.6.1.1
In Commercial Distribution

  • 00810055812837 ()


  • Blood bank information system application software
No Description
SCC SOFT COMPUTER
1.0.0.18
In Commercial Distribution

  • 00810055812257 ()


  • Bedside information system application software
No Description
SCC SOFT COMPUTER
25.5.6.2
In Commercial Distribution

  • 00810055810727 ()


  • Blood bank information system application software
No Description
Naturalcycles Nordic AB
V5.4.0
In Commercial Distribution

  • 07350014630339 ()


  • Self-care monitoring/reporting software
No Description
Naturalcycles Nordic AB
V5.0
In Commercial Distribution

  • 07350014630285 ()


  • Self-care monitoring/reporting software
Package for 6-month subscription of Natural Cycles. Includes a Basal Body Thermometer and a subscription code for 6 months access to the app.
Naturalcycles Nordic AB
13
In Commercial Distribution

  • 07350014630131 ()


  • Self-care monitoring/reporting software
No Description
Naturalcycles Nordic AB
B
In Commercial Distribution

  • 07350014630124 ()


  • Self-care monitoring/reporting software
ORTHONOL(R) PREFORM NATURAL ARCH MX .017 X .025 34MM
Rmo, Inc.
A07075
In Commercial Distribution

  • 00000008857972 ()
  • 00885797019837 ()


  • Orthodontic archwire
VA version of Baha Fitting Software 7
Cochlear Bone Anchored Solutions AB
V 7.0
In Commercial Distribution

  • 09321502075527 ()
P2121915

  • Hearing aid wireless-fitting computer-aided set
Task Force Monitor Software inkl. Kunden-CD (multilingual)
CNSystems Medizintechnik AG
V2.3
Not in Commercial Distribution

  • 09120073931009 ()


  • Noninvasive haemodynamic monitoring system
Grael EEG v2 System with EEG software
COMPUMEDICS LIMITED
Grael EEG
In Commercial Distribution

  • 09342451001825 ()
9028-0004-02

  • Electroencephalograph
KOSMOS OTS iOS SOFTWARE PACKAGE [2.X]
ECHONOUS, INC.
P007944
In Commercial Distribution

  • 09353278000762 ()


  • Ultrasound imaging system application software
EchoNous (Uscan) Samsung S8 Tablet with Software
ECHONOUS, INC.
P007635
In Commercial Distribution

  • 09353278000663 ()


  • Hand-held ultrasound imaging system, body-surface
Software for Smart Room Controller, Version 1.8.7
AMPLION CLINICAL COMMUNICATIONS, INC.
S-SRC-187-1
Not in Commercial Distribution

  • 00850016398390 ()
S-SRC-187-1

  • Nurse call system
Software for Nurse Station Console, Version 2.2.0.0
AMPLION CLINICAL COMMUNICATIONS, INC.
S-NSC-2200-1
Not in Commercial Distribution

  • 00850016398383 ()
S-NSC-2200-1

  • Nurse call system
Software for Code Blue Annunciator, Version 1.8.7
AMPLION CLINICAL COMMUNICATIONS, INC.
S-CBA-187-1
Not in Commercial Distribution

  • 00850016398345 ()
S-CBA-187-1

  • Nurse call system
Control software for the ATLAS Stim Headbox.
NEURALYNX, INC.
1.5.1
Not in Commercial Distribution

  • 00850011306703 ()
36-0301-0006

  • Somatosensory electrical stimulation system
SOFTWARE 9734472 SONONAV CAL APP FOR SC
MEDTRONIC NAVIGATION, INC.
9734472
In Commercial Distribution

  • 00643169183407 ()


  • Multi-purpose stereotactic surgery system
Software for Nurse Station Console, Version 2.4.1
AMPLION CLINICAL COMMUNICATIONS, INC.
S-NSC-241-1
Not in Commercial Distribution

  • 00850016398772 ()
S-NSC-241-1

  • Nurse call system
Software for Code Blue Annunciator, Version 1.8.8
AMPLION CLINICAL COMMUNICATIONS, INC.
S-CBA-188-1
Not in Commercial Distribution

  • 00850016398758 ()
S-CBA-188-1

  • Nurse call system
Leica Biosystems CytoVision Karyotype & FISH Software Update
Leica Biosystems Richmond, Inc.
23SWR002KFL001
Not in Commercial Distribution

  • 00849832003687 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica CytoVision Karyotyping review software (incl. dongle)
Leica Biosystems Richmond, Inc.
23SWR000KXX001
Not in Commercial Distribution

  • 00849832003656 ()

  • Device Size Text, specify:


  • Laboratory analyser operation system software IVD
Leica Biosystems CytoVision Karyotyping Software License Activation
Leica Biosystems Richmond, Inc.
23SWR000KLX001
Not in Commercial Distribution

  • 00849832003649 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision Karyotyping & FISH Review software
Leica Biosystems Richmond, Inc.
23SWR000KFX001
Not in Commercial Distribution

  • 00849832003632 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Licence, Software, LiDCOrapid (Rapid, CNAP, BIS, Ext)
LIDCO LIMITED
Li11076
In Commercial Distribution

  • 05060110522330 ()
Li11076

  • General-purpose multi-parameter bedside monitor
SOFTWARE KIT 9733652 FUSION SW WITH PG
MEDTRONIC NAVIGATION, INC.
9733652
In Commercial Distribution

  • 00613994378798 ()


  • ENT stereotactic surgery system
SOFTWARE MMT-7310 SOLNS EA CGMS V3.0C EN
MEDTRONIC MINIMED, INC.
MMT-7310
In Commercial Distribution

  • 00613994675293 ()


  • Home healthcare information system
SOFTWARE KIT 9733652XOM FUSION SW W/PG
MEDTRONIC NAVIGATION, INC.
9733652XOM
In Commercial Distribution

  • 00613994469199 ()


  • ENT stereotactic surgery system
SFTWR KIT 9733933XOM DICOM SOFTWARE Q/R
MEDTRONIC NAVIGATION, INC.
9733933XOM
In Commercial Distribution

  • 00613994481115 ()


  • Multi-purpose stereotactic surgery system
SFTWR KIT 9733933 DICOM SOFTWARE Q/R
MEDTRONIC NAVIGATION, INC.
9733933
In Commercial Distribution

  • 00613994467072 ()


  • Multi-purpose stereotactic surgery system
Digital stethoscope and hosted software application solution.
Globalmed Holdings, LLC
GSW30100103
In Commercial Distribution

  • 00850033167108 ()
GSW30100103

  • Stethoscope application software
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