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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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CEREC Software Version 4.6.0
SIRONA Dental Systems GmbH
6660067
In Commercial Distribution

  • E27666600670 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
CEREC Premium 4.4.4 Software
SIRONA Dental Systems GmbH
6612985
In Commercial Distribution

  • E27666129850 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
CEREC Premium 4.5.0 Software
SIRONA Dental Systems GmbH
6610435
In Commercial Distribution

  • E27666104350 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
inLab CAM 16.0 Software
SIRONA Dental Systems GmbH
6610161
In Commercial Distribution

  • E27666101610 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
SOFTWARE INTEGRATION BROKER HL7
Smith & Nephew, Inc.
72201079
Not in Commercial Distribution

  • 03596010589637 ()
72201079

  • Robotic surgical navigation system application software
INTEGRATION SOFTWARE BROKER, DICOM
Smith & Nephew, Inc.
72201081
In Commercial Distribution

  • 03596010588371 ()
72201081

  • Robotic surgical navigation system application software
DYONICS II SOFTWARE UPGRADE
Smith & Nephew, Inc.
72202103
In Commercial Distribution

  • 03596010622716 ()
72202103

  • Arthroscopic shaver system, electrically-powered
Centralized Configuration Manager Software
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
000GCCM
In Commercial Distribution

  • 10711234540121 ()
000GCCM

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
Holter Analysis Software Apnea
Northeast Monitoring, Inc.
Holter Analysis Software Apnea
In Commercial Distribution

  • M582NEMK1270 ()
M582NEMK127

  • Cardiac arrhythmia monitoring system
Holter Analysis Software Pro
Northeast Monitoring, Inc.
Pro
In Commercial Distribution

  • M581NEMK1630 ()
NEMK163

  • Cardiac arrhythmia monitoring system
Holter Analysis Software Enhanced
Northeast Monitoring, Inc.
Enhanced
In Commercial Distribution

  • M581NEMK1610 ()
NEMK161

  • Cardiac arrhythmia monitoring system
Holter Analysis Software Basic
Northeast Monitoring, Inc.
Basic
In Commercial Distribution

  • M581NEMK1600 ()
NEMK160

  • Cardiac arrhythmia monitoring system
TRUEmanager Diabetes Management Software
TRIVIDIA HEALTH, INC.
TRUEmanager Diabetes Management Software
In Commercial Distribution

  • 00021292008666 ()
RM9NPD78

  • Self-care monitoring/reporting software
Vitek 2 software V10
BIOMERIEUX , INC.
10.0
In Commercial Distribution

  • 03573026618285 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
VIDAS 3 V1.4 Software
BIOMERIEUX SA
1.4
In Commercial Distribution

  • 03573026617622 ()


  • Fluorescent immunoassay analyser IVD, laboratory
Alaris EtCO2 V12.3 Software
CAREFUSION 303, INC.
8300
In Commercial Distribution

  • 10885403516054 ()


  • Carbon dioxide monitor
VITAL SYNC V2 SOFTWARE
Covidien LP
VITALSYNCSW01
In Commercial Distribution

  • 10884521806740 ()


  • Multiparameter physiologic analysis workstation
VITAL SYNC V2 SOFTWARE
Covidien LP
VITALSYNCSW01
In Commercial Distribution

  • 10884521795273 ()


  • Multiparameter physiologic analysis workstation
VITAL SYNC V2 SOFTWARE
Covidien LP
VITALSYNCSW01
In Commercial Distribution

  • 10884521780668 ()


  • Multiparameter physiologic analysis workstation
VITAL SYNC V2 SOFTWARE
Covidien LP
VITALSYNCSW01
In Commercial Distribution

  • 10884521762619 ()


  • Multiparameter physiologic analysis workstation
VITAL SYNC V4 SOFTWARE
Covidien LP
VITALSYNCSW04
In Commercial Distribution

  • 10884521854260 ()


  • Multiparameter physiologic analysis workstation
VITAL SYNC V3 SOFTWARE
Covidien LP
VITALSYNCSW03
In Commercial Distribution

  • 10884521844940 ()


  • Multiparameter physiologic analysis workstation
VITAL SYNC V3 SOFTWARE
Covidien LP
VITALSYNCSW03
In Commercial Distribution

  • 10884521844933 ()


  • Multiparameter physiologic analysis workstation
VITAL SYNC V2 SOFTWARE
Covidien LP
VSMASW03
In Commercial Distribution

  • 10884521835962 ()


  • Multiparameter physiologic analysis workstation
VITAL SYNC V3 SOFTWARE
Covidien LP
VITALSYNCSW03
In Commercial Distribution

  • 10884521835870 ()


  • Multiparameter physiologic analysis workstation
VITAL SYNC V2 SOFTWARE
Covidien LP
VSMASW03
In Commercial Distribution

  • 10884521823372 ()


  • Multiparameter physiologic analysis workstation
VITAL SYNC V2 SOFTWARE
Covidien LP
VITALSYNCSW03
In Commercial Distribution

  • 10884521818965 ()


  • Multiparameter physiologic analysis workstation
VITAL SYNC V4 SOFTWARE
Covidien LP
VITALSYNCSW04
In Commercial Distribution

  • 10884521849358 ()


  • Multiparameter physiologic analysis workstation
VITAL SYNC V2 SOFTWARE
Covidien LP
VSMASW03
In Commercial Distribution

  • 10884521847675 ()


  • Multiparameter physiologic analysis workstation
VITAL SYNC V3 SOFTWARE
Covidien LP
VITALSYNCSW03
In Commercial Distribution

  • 10884521847569 ()


  • Multiparameter physiologic analysis workstation
VITAL SYNC V2 SOFTWARE
Covidien LP
VSMASW03
In Commercial Distribution

  • 10884521845176 ()


  • Multiparameter physiologic analysis workstation
VITAL SYNC V3 SOFTWARE
Covidien LP
VITALSYNCSW03
In Commercial Distribution

  • 10884521829855 ()


  • Multiparameter physiologic analysis workstation
VITAL SYNC V3 SOFTWARE
Covidien LP
VITALSYNCSW03
In Commercial Distribution

  • 10884521829848 ()


  • Multiparameter physiologic analysis workstation
VITAL SYNC V2 SOFTWARE
Covidien LP
VITALSYNCSW01
In Commercial Distribution

  • 10884521812208 ()


  • Multiparameter physiologic analysis workstation
VITAL SYNC V2 SOFTWARE
Covidien LP
VITALSYNCSW01
In Commercial Distribution

  • 10884521810334 ()


  • Multiparameter physiologic analysis workstation
ORTHOPILOT SOFTWARE THA PLUS
Aesculap AG
FS217
In Commercial Distribution

  • 04046963181901 ()
FS217

  • Robotic surgical navigation system application software
SOFTWARE MODULE DIR 800
Aesculap AG
PV023
In Commercial Distribution

  • 04046955206803 ()
PV023

  • Surgical microscope fluorescent angiography system
SOFTWARE MODULE DUV 400
Aesculap AG
PV022
In Commercial Distribution

  • 04046955206797 ()
PV022

  • Neurosurgical microscope
ORTHOPILOT SOFTWARE THA ACA
Aesculap AG
FS229
Not in Commercial Distribution

  • 04046963989101 ()
FS229

  • Robotic surgical navigation system application software
MAXFRAME(TM) 2.0 SOFTWARE
Synthes GmbH
03.312.002
In Commercial Distribution

  • 07612334226563 ()
  • 10886982308641 ()
03312002

  • External orthopaedic fixation frame calculation software
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