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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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Spirometry PC Software
Jaeger Medical GmbH
2.5
In Commercial Distribution

  • 04250892904153 ()
36-SWR1134

  • Diagnostic spirometer, professional
myQA iON software
IBA Dosimetry GmbH
MQ10-000
In Commercial Distribution

  • EIBAMQ100000 ()


  • Accelerator system quality assurance device
myQA Daily Software
IBA Dosimetry GmbH
DQ00000
In Commercial Distribution

  • EIBADQ000000 ()
DQ00-000

  • Accelerator system quality assurance device
Hearing implant software
COCHLEAR LIMITED
v7.1, US
In Commercial Distribution

  • 09321502072359 ()
P1947519

  • Audiometric/hearing device software
Hearing implant software
COCHLEAR LIMITED
v 2.0
In Commercial Distribution

  • 09321502070416 ()
P1986795

  • Cochlear implant intraoperative electrophysiological analysis software
Hearing implant software
COCHLEAR LIMITED
P1799437
In Commercial Distribution

  • 09321502065917 ()
P1799437

  • Cochlear implant intraoperative electrophysiological analysis software
MAXFRAME(TM) SOFTWARE
SYNTHES (U.S.A.) LP
03.312.000
In Commercial Distribution

  • 07612334140258 ()
  • H679033120000 ()
  • 10886982260949 ()
03312000

  • External orthopaedic fixation frame calculation software
Dental CADCAM Software
Dental Wings Inc
2
In Commercial Distribution

  • D840DWOSCS1 ()


  • Dental milling system, CAD/CAM, chairside
Dental CADCAM Software
Dental Wings Inc
9
In Commercial Distribution

  • D840DWOSCAD1 ()


  • Dental milling system, CAD/CAM, laboratory
EVASOFT IMAGING SOFTWARE
ImageWorks
9992490800
In Commercial Distribution

  • D83399924908000 ()
9992490800

  • General-purpose dental x-ray system application software
Instrument selection software
Brainlab AG
1.5
In Commercial Distribution

  • 04056481142018 ()


  • Robotic surgical navigation system
Progeny Imaging Software
MIDMARK CORPORATION
500-427
In Commercial Distribution

  • 00841709105661 ()
500-427

  • General-purpose dental x-ray system application software
Application System Software
Omni Life Science, Inc.
2205-2000
In Commercial Distribution

  • 00841690194699 ()
2205-2000

  • Robotic surgical navigation system application software
Knee Software Package
Omni Life Science, Inc.
NS-27003
In Commercial Distribution

  • 00841690194545 ()
NS-27003

  • Instrument tray, reusable
SOFTWARE MODULE DICOM
Aesculap AG
PV024
In Commercial Distribution

  • 04046955206810 ()
PV024

  • Neurosurgical microscope
Arial 11 Software
Securitas Healthcare LLC
54305
In Commercial Distribution

  • 00840948102769 ()
54305

  • Fixed call button
Arial U Software
Securitas Healthcare LLC
56112
In Commercial Distribution

  • 00840948101021 ()


  • Medical networking interface unit
Planning Software V1.0
Covidien LP
Planning Application V1.0
In Commercial Distribution

  • 10884521779990 ()


  • Electromagnetic surgical navigation device tracking system
Procedure Software V1.0
Covidien LP
Procedure Application V1.0
In Commercial Distribution

  • 10884521779983 ()


  • Electromagnetic surgical navigation device tracking system
v7.1 Planning Software
Covidien LP
PMB00569-01
In Commercial Distribution

  • 10884521747432 ()


  • Electromagnetic surgical navigation device tracking system
v7.2 Procedure Software
Covidien LP
PMB00667-01
In Commercial Distribution

  • 10884521747425 ()


  • Electromagnetic surgical navigation device tracking system
Digital Imaging Software
DRGEM Corporation
RADMAX
In Commercial Distribution

  • 08800011170004 ()


  • Basic diagnostic x-ray system application software
Hypertension Management Software
IEM GmbH
HMS CS 6.1.3 Medtronic 1.0.0
In Commercial Distribution

  • 04041346102054 ()


  • Medical equipment clinical data interfacing software
ORTHOPILOT SOFTWARE ACL
Aesculap AG
FS215
Not in Commercial Distribution

  • 04038653423316 ()
FS215

  • Robotic surgical navigation system application software
Software Pristina Infinity
GE MEDICAL SYSTEMS
PRISTINA 2.0
In Commercial Distribution

  • 00840682146845 ()


  • Mammographic x-ray system stereotactic unit
  • Stationary mammographic x-ray system, digital
sterEOS workstation software
EOS IMAGING
Software 1.8
In Commercial Distribution

  • 03663999000054 ()


  • Basic diagnostic x-ray system application software
sterEOS workstation software
EOS IMAGING
Software 1.6
In Commercial Distribution

  • 03663999000030 ()


  • Basic diagnostic x-ray system application software
Connect 4.5.0 Software
SIRONA Dental Systems GmbH
6620780
In Commercial Distribution

  • E27666207800 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
CEREC 4.4.4 Software
SIRONA Dental Systems GmbH
6613009
In Commercial Distribution

  • E27666130090 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
Connect 4.4.4 Software
SIRONA Dental Systems GmbH
6610468
In Commercial Distribution

  • E27666104680 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
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