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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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SOFTWARE, 9732430, SPINE UNIFIED
MEDTRONIC NAVIGATION, INC.
9732430
In Commercial Distribution

  • 00885074445465 ()


  • Multi-purpose stereotactic surgery system
Q-Stress Server - version 6, current software CD; Software kit; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094308440 ()
QSERV-6AA-XXXXX

  • Electrocardiographic lead set, reusable
HScribe Server - version 6, current software CD; Software kit; No connectivity
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094263978 ()
HSERV-6AA-XXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software
The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR), with results that are intended to be used in conjunction with clinical evaluation as an aid in the assessment of kidney health.
HEALTHY.IO LTD
MNT KDN.US.GEN
In Commercial Distribution

  • 17290017272471 ()


  • Self-testing data clinician presentation application software IVD
Alaris Systems Maintenance v12.3-v.12.5
CAREFUSION 303, INC.
8975
In Commercial Distribution

  • 10885403897535 ()


  • Infusion pump medication-dosage application software
Alaris Guardrails Editor 12-12.1.3
CAREFUSION 303, INC.
8961
In Commercial Distribution

  • 10885403896125 ()


  • Infusion pump medication-dosage application software
Alaris Guardrails Editor 12.1.4
CAREFUSION 303, INC.
8961
In Commercial Distribution

  • 10885403520020 ()


  • Infusion pump medication-dosage application software
No Description
ICU MEDICAL, INC.
22-4095-0204-25
In Commercial Distribution

  • 15019517088632 ()


  • Infusion pump medication-dosage application software
Stratus EEG is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipment that is imported into the system. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions.
Kvikna Medical ehf.
Client Software
In Commercial Distribution



  • Bioelectrical signal analysis software
Stratus EEG is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipment that is imported into the system. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions.
Kvikna Medical ehf.
Server Software
In Commercial Distribution



  • Bioelectrical signal analysis software
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