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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Oncentra External Beam Oncentra Brachy v4.6.1
Nucletron B.V.
170607-00
In Commercial Distribution

  • 08717213052758 ()


  • Radiation therapy software
Oncentra External Beam/Oncentra Brachy v4.5.3
Nucletron B.V.
170003-28
In Commercial Distribution

  • 08717213052314 ()


  • Radiation therapy software
Oncentra External Beam/Oncentra Brachy v4.5.3
Nucletron B.V.
170003-27
Not in Commercial Distribution

  • 08717213052291 ()


  • Radiation therapy software
Oncentra External Beam/Oncentra Brachy v4.5.3
Nucletron B.V.
170003-25
Not in Commercial Distribution

  • 08717213052239 ()


  • Radiation therapy software
Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170537-05
Not in Commercial Distribution

  • 08717213051881 ()


  • Radiation therapy software
Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170537-04
Not in Commercial Distribution

  • 08717213051782 ()


  • Radiation therapy software
Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170730
Not in Commercial Distribution

  • 08717213051294 ()


  • Radiation therapy software
Oncentra External Beam 4.5.3/Oncentra Brachy v4.6
Nucletron B.V.
170018-00
In Commercial Distribution

  • 08717213053700 ()
  • 08717213054004 ()
  • 08717213053991 ()


  • Radiation therapy software
Oncentra External Beam/Oncentra Brachy v4.5.3
Nucletron B.V.
170537-08
In Commercial Distribution

  • 08717213052321 ()


  • Radiation therapy software
Oncentra External Beam/Oncentra Brachy v4.5.3
Nucletron B.V.
170537-06
Not in Commercial Distribution

  • 08717213052307 ()


  • Radiation therapy software
Oncentra External Beam/Oncentra Brachy v4.5.3
Nucletron B.V.
170537-06
Not in Commercial Distribution

  • 08717213052246 ()


  • Radiation therapy software
Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170003-24
Not in Commercial Distribution

  • 08717213051843 ()


  • Radiation therapy software
Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170003-23
Not in Commercial Distribution

  • 08717213051775 ()


  • Radiation therapy software
Sidexis 4 (Update) 4.4
SIRONA Dental Systems GmbH
6775592
In Commercial Distribution

  • E27667755921 ()


  • Radiological PACS software
Sidexis 4 (Upgrade) 4.4
SIRONA Dental Systems GmbH
6775584
In Commercial Distribution

  • E27667755841 ()


  • Radiological PACS software
Sidexis 4 (Full version) 4.4
SIRONA Dental Systems GmbH
6773787
In Commercial Distribution

  • E27667737871 ()


  • Radiological PACS software
Sidexis 4 V4.4
SIRONA Dental Systems GmbH
6773258
In Commercial Distribution

  • E27667732580 ()


  • Radiological PACS software
CEREC AC 2.0 with Omnicam camera and touch pad
SIRONA Dental Systems GmbH
6667237
In Commercial Distribution

  • E27666672370 ()


  • CAD/CAM software
CEREC AC 2.0 with QCC camera and touch pad
SIRONA Dental Systems GmbH
6667211
In Commercial Distribution

  • E27666672110 ()


  • CAD/CAM software
Sidexis 4 Basis-DVD
SIRONA Dental Systems GmbH
6663277
In Commercial Distribution

  • E27666632770 ()


  • Radiological PACS software
Sidexis Update
SIRONA Dental Systems GmbH
6618263
In Commercial Distribution

  • E27666182630 ()


  • Radiological PACS software
Sidexis 4 Basis-DVD
SIRONA Dental Systems GmbH
6616465
In Commercial Distribution



  • Radiological PACS software
CEREC SW 4.4.1
SIRONA Dental Systems GmbH
6580265
In Commercial Distribution

  • E27665802650 ()


  • CAD/CAM software
CEREC Premium CAM SW 4.4.0
SIRONA Dental Systems GmbH
6574250
In Commercial Distribution

  • E27665742500 ()


  • CAD/CAM software
CEREC AF Connect with Omnicam
SIRONA Dental Systems GmbH
6564715
In Commercial Distribution

  • E27665647150 ()


  • CAD/CAM software
CEREC AI Connect with Omnicam
SIRONA Dental Systems GmbH
6564707
In Commercial Distribution

  • E27665647070 ()


  • CAD/CAM software
CEREC Ortho SW 1.1
SIRONA Dental Systems GmbH
6562107
Not in Commercial Distribution

  • E27665621070 ()


  • CAD/CAM software
inLab CAM 15.0
SIRONA Dental Systems GmbH
6553882
In Commercial Distribution

  • E27665538820 ()


  • CAD/CAM software
inLab SW 15.0
SIRONA Dental Systems GmbH
6553874
In Commercial Distribution

  • E27665538740 ()


  • CAD/CAM software
CEREC Premium SW 4.4.0
SIRONA Dental Systems GmbH
6553031
In Commercial Distribution

  • E27665530310 ()


  • CAD/CAM software
CEREC SW 4.4
SIRONA Dental Systems GmbH
6553023
In Commercial Distribution

  • E27665530230 ()


  • CAD/CAM software
inCoris PMMA guide disc 22
SIRONA Dental Systems GmbH
6551324
In Commercial Distribution

  • E27665513242 ()


  • CAD/CAM software
CEREC AI without CEREC Omnicam
SIRONA Dental Systems GmbH
6542901
In Commercial Distribution

  • E27665429010 ()


  • CAD/CAM software
CEREC AF without CEREC Omnicam
SIRONA Dental Systems GmbH
6542893
In Commercial Distribution

  • E27665428930 ()


  • CAD/CAM software
CEREC AI with CEREC Omnicam
SIRONA Dental Systems GmbH
6534791
In Commercial Distribution

  • E27665347910 ()


  • CAD/CAM software
CEREC AF with CEREC Omnicam
SIRONA Dental Systems GmbH
6532076
In Commercial Distribution

  • E27665320760 ()


  • CAD/CAM software
CEREC Guide Bloc medi
SIRONA Dental Systems GmbH
6466564
In Commercial Distribution

  • E27664665642 ()


  • CAD/CAM software
CEREC Guide Pilot Drill Keys 2.2
SIRONA Dental Systems GmbH
6462563
In Commercial Distribution

  • E27664625632 ()


  • CAD/CAM software
CEREC Guide Pilot Drill Keys 2.0
SIRONA Dental Systems GmbH
6462530
In Commercial Distribution

  • E27664625302 ()


  • CAD/CAM software
SIDEXIS 4 Basis-DVD
SIRONA Dental Systems GmbH
6456532
In Commercial Distribution

  • E27664565320 ()


  • Radiological PACS software
CEREC Guide Bloc maxi
SIRONA Dental Systems GmbH
6447093
In Commercial Distribution

  • E27664470932 ()


  • CAD/CAM software
CEREC AC Connect Omnicam
SIRONA Dental Systems GmbH
6431519
In Commercial Distribution

  • E27664315190 ()


  • CAD/CAM software
APOLLO DI
SIRONA Dental Systems GmbH
6418375
Not in Commercial Distribution

  • E27664183750 ()


  • CAD/CAM software
Cerec Guide Blocs L
SIRONA Dental Systems GmbH
6375070
Not in Commercial Distribution

  • E27663750702 ()


  • CAD/CAM software
Cerec Guide Blocs M
SIRONA Dental Systems GmbH
6375062
Not in Commercial Distribution

  • E27663750622 ()


  • CAD/CAM software
Cerec Guide Blocs S
SIRONA Dental Systems GmbH
6375054
In Commercial Distribution

  • E27663750542 ()


  • CAD/CAM software
CEREC Guide Drill Key Set B
SIRONA Dental Systems GmbH
6373968
In Commercial Distribution

  • E27663739682 ()


  • CAD/CAM software
Cerec Guide Drill Key Set AT
SIRONA Dental Systems GmbH
6373950
In Commercial Distribution

  • E27663739502 ()


  • CAD/CAM software
CEREC Guide Drill Key Set NB
SIRONA Dental Systems GmbH
6373943
In Commercial Distribution

  • E27663739432 ()


  • CAD/CAM software
CEREC Guide Drill Key Set C
SIRONA Dental Systems GmbH
6373729
In Commercial Distribution

  • E27663737292 ()


  • CAD/CAM software
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