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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 version 9.X
Philips Ultrasound LLC
795121
In Commercial Distribution

  • 00884838113909 ()


  • General-purpose ultrasound imaging system
Software version 7.x
Philips Ultrasound LLC
795121
In Commercial Distribution

  • 00884838113893 ()


  • General-purpose ultrasound imaging system
Software Version 9.X
Philips Ultrasound LLC
795120
In Commercial Distribution

  • 00884838113886 ()


  • General-purpose ultrasound imaging system
Software version 9.X
Philips Ultrasound LLC
795119
In Commercial Distribution

  • 00884838113862 ()


  • General-purpose ultrasound imaging system
Software version 7.x
Philips Ultrasound LLC
795119
In Commercial Distribution

  • 00884838113855 ()


  • General-purpose ultrasound imaging system
Software Version 7.X
Philips Ultrasound LLC
795118
In Commercial Distribution

  • 00884838113831 ()


  • General-purpose ultrasound imaging system
Software Version 9.X
Philips Ultrasound LLC
795117
In Commercial Distribution

  • 00884838113824 ()


  • General-purpose ultrasound imaging system
Software version 3.X
Philips Ultrasound LLC
795116
In Commercial Distribution

  • 00884838113800 ()


  • General-purpose ultrasound imaging system
Software version 2.X
Philips Ultrasound LLC
795116
In Commercial Distribution

  • 00884838113794 ()


  • General-purpose ultrasound imaging system
Software version 5.X
Philips Ultrasound LLC
795114
In Commercial Distribution

  • 00884838113787 ()


  • General-purpose ultrasound imaging system
UroNav Fusion Biopsy Software
Philips DS North America LLC
784015
In Commercial Distribution

  • 00884838081550 ()


  • Stereotactic system application software
Cardiac PET Processing Software
Bracco Diagnostics Inc.
4
In Commercial Distribution

  • 30815112021543 ()
001771

  • Image segmentation application software
Connect Software Version 5.2
SIRONA Dental Systems GmbH
6764877
In Commercial Distribution

  • E27667648770 ()


  • CAD/CAM software
OraCheck Software Version 5.0.0
SIRONA Dental Systems GmbH
6733336
In Commercial Distribution

  • E27667333360 ()


  • CAD/CAM software
Connect Software Version 5.1.0
SIRONA Dental Systems GmbH
6728815
In Commercial Distribution

  • E27667288150 ()


  • CAD/CAM software
CEREC Software Version 5.1.0
SIRONA Dental Systems GmbH
6716174
In Commercial Distribution

  • E27667161740 ()


  • CAD/CAM software
Connect Software Version 5.0.0
SIRONA Dental Systems GmbH
6686831
In Commercial Distribution

  • E27666868310 ()


  • CAD/CAM software
CEREC Software Version 5.0.0
SIRONA Dental Systems GmbH
6682228
In Commercial Distribution

  • E27666822280 ()


  • CAD/CAM software
Connect Software Version 4.6.0
SIRONA Dental Systems GmbH
6666718
In Commercial Distribution

  • E27666667180 ()


  • CAD/CAM software
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
syngo Application Software VD1
Siemens Healthcare GmbH
10849124
In Commercial Distribution

  • 04056869012902 ()


  • Basic diagnostic x-ray system application software
syngo Application Software VE3
Siemens Healthcare GmbH
30000266
In Commercial Distribution

  • 04056869964546 ()


  • Basic diagnostic x-ray system application software
syngo Application Software VE4
Siemens Healthcare GmbH
30000267
In Commercial Distribution

  • 04056869964539 ()


  • Basic diagnostic x-ray system application software
syngo Dynamics VA40 Software
Siemens Healthcare GmbH
10745960
In Commercial Distribution

  • 04056869253244 ()


  • Radiological PACS software
syngo Application Software VE2
Siemens Healthcare GmbH
11327667
In Commercial Distribution

  • 04056869124162 ()


  • Basic diagnostic x-ray system application software
syngo Application Software VD2
Siemens Healthcare GmbH
10849231
In Commercial Distribution

  • 04056869050874 ()


  • Basic diagnostic x-ray system application software
Orthex P&C Software
VILEX IN TENNESSEE, INC.
ORTHEXRPS
Not in Commercial Distribution

  • 00841731119209 ()


  • External orthopaedic fixation frame calculation software
AIDA 2.0 Office Software
Karl Storz GmbH & Co. KG
20040013-V01
In Commercial Distribution

  • 04048551012888 ()


  • Operating room audiovisual data/device management system application software
MAXFRAME AUTOSTRUT (TM) SOFTWARE
Synthes GmbH
03.312.003
In Commercial Distribution

  • 10886982346896 ()
03312003

  • External orthopaedic fixation frame calculation software
MAXFRAME AUTOSTRUT(TM) SOFTWARE
SYNTHES (U.S.A.) LP
1110005-01
In Commercial Distribution

  • 10886982340832 ()
111000501

  • External orthopaedic fixation frame calculation software
Dental implant planning software
Dental Wings GmbH
9
Not in Commercial Distribution

  • D835CDX202 ()
  • D835CDX1 ()
  • D835CDX201 ()
  • D835CDX200 ()


  • Diagnostic x-ray digital imaging system workstation
Alaris EtCO2 V12.3 Software
CAREFUSION 303, INC.
8300
In Commercial Distribution

  • 10885403516054 ()


  • Carbon dioxide monitor
ORTHOPILOT SOFTWARE THA PLUS
Aesculap AG
FS217
In Commercial Distribution

  • 04046963181901 ()
FS217

  • Robotic surgical navigation system application software
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
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