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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No Description
Archform Inc.
Various
In Commercial Distribution

  • 00860012168521 ()
2

  • CAD/CAM software
3D Bolus Software is indicated for, and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-specific 3D-printable objects intended for use during external beam photon or electron radiation therapy, or brachytherapy.
Adaptiiv Medical Technologies Inc
v3.0.0
In Commercial Distribution

  • 00860007402302 ()


  • Radiation therapy software
Version 15.0
Philips Ultrasound LLC
989606710071
In Commercial Distribution

  • 00884838098220 ()


  • Radiological PACS software
No Description
Philips Ultrasound LLC
Release 10.7
In Commercial Distribution

  • 00884838070837 ()


  • Radiological PACS software
No Description
Philips Ultrasound LLC
Release 10.5
In Commercial Distribution

  • 00884838059788 ()


  • Radiological PACS software
No Description
Philips Ultrasound LLC
Release 10.8.5
In Commercial Distribution

  • 00884838086616 ()


  • Radiological PACS software
No Description
Philips Ultrasound LLC
Release 3.8
In Commercial Distribution

  • 00884838083509 ()


  • Radiological PACS software
The Eonis Analysis Software is intended for in vitro diagnostic use for analysis of the real time PCR data generated usingthe Eonis PCR Reagent Kit for the semi-quantitative determination of TREC (signal joint T-cell receptor excision circle)and KREC (Kappa-deleting recombination excision circle), as well as the qualitative detection of the exon 7 of SMN1gene and RPP30 (Ribonuclease P/MRP Subunit P30) gene in DNA from blood specimens dried on a filter paper as an aidin screening newborns for Severe Combined Immunodeficiency (SCID), X-linked agammaglobulinemia (XLA) and SpinalMuscular Atrophy (SMA).
Wallac Oy
5020-1000
In Commercial Distribution

  • 06438147373901 ()
5020-1000

  • Human genomic analysis interpretive software IVD
No Description
Biomet Orthopedics, LLC
CG100
Not in Commercial Distribution

  • 00880304992863 ()
CG100

  • Orthopaedic/craniofacial implantation planning software
Software used by the clinician to interface with the WalkAide unit. This allows data collection, analysis and parameter modification in order to correctly time the applied stimulation to the user.
INNOVATIVE NEUROTRONICS, INC.
20-0603
In Commercial Distribution

  • 00858184006130 ()


  • Gait-enhancement electrical stimulation system, external
Software version for Amicus Separator
Fresenius Kabi AG
6.0
In Commercial Distribution

  • 04086000101912 ()


  • Apheresis system
Software version for Amicus Separator.
Fresenius Kabi AG
5.12
In Commercial Distribution

  • 04086000101660 ()


  • Apheresis system
Software version for Amicus Separator.
Fresenius Kabi AG
5.121
In Commercial Distribution

  • 04086000101653 ()


  • Apheresis system
Software version for Aurora Xi.
Fresenius Kabi AG
1.1
In Commercial Distribution

  • 04086000101516 ()


  • Apheresis system
Care Orchestrator Clinical Management Data Software
Respironics, Inc.
1.13
In Commercial Distribution

  • 00606959050730 ()
1126366

  • Medical equipment clinical data interfacing software
No Description
ergoline GmbH
161801
In Commercial Distribution

  • 04059358001838 ()


  • Cardiopulmonary parameter spot-check measurement software
The Alignment Software Spine is intended to support the surgeon in reaching a predefined position through semi-automated alignment of surgical instruments based on information obtained from optical tracking devices.
Brainlab AG
2.1
In Commercial Distribution

  • 04056481146320 ()


  • Electromagnetic/optical surgical navigation device tracking system
The Alignment Software Cranial is a software which enables navigated surgery. It is intended to support the surgeon in planning and reaching a pre-defined position through manual or semi-automated navigation of surgical instruments based on information obtained from optical tracking devices.
Brainlab AG
2.0
In Commercial Distribution

  • 04056481144487 ()


  • Electromagnetic/optical surgical navigation device tracking system
The Alignment Software Spine supports the surgeon in reaching a pre-defined position by controlling and monitoring the movement of the Cirq Robotic Alignment Module.
Brainlab AG
2.0
In Commercial Distribution

  • 04056481144470 ()


  • Electromagnetic/optical surgical navigation device tracking system
syngo Application Software VD3; covered by NFJ to K170747/K173611 syngo Application Software VD2
Siemens Healthcare GmbH
11328180
In Commercial Distribution

  • 04056869262567 ()


  • Basic diagnostic x-ray system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11149926
Not in Commercial Distribution

  • 04056869006840 ()


  • Radiological PACS software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10855671
Not in Commercial Distribution

  • 04056869001067 ()


  • Radiological PACS software
No Description
Brainlab AG
3.5
In Commercial Distribution

  • 04056481140687 ()


  • Robotic surgical navigation system
No Description
Brainlab AG
3.5
Not in Commercial Distribution

  • 04056481140663 ()


  • Robotic surgical navigation system
No Description
Brainlab AG
3.0
Not in Commercial Distribution

  • 04056481138790 ()
26615-01

  • Robotic surgical navigation system
No Description
Brainlab AG
3.0
Not in Commercial Distribution

  • 04056481138783 ()
26614-01

  • Robotic surgical navigation system
CEREC SW 5.3 Workstation dig., Secondary
SIRONA Dental Systems GmbH
6834704
In Commercial Distribution

  • E27668347040 ()
6834704

  • CAD/CAM software
CEREC SW 5.3 Workstation, Secondary
SIRONA Dental Systems GmbH
6834696
In Commercial Distribution

  • E27668346960 ()
6834696

  • CAD/CAM software
CEREC SW 5.3 license upgrade digital
SIRONA Dental Systems GmbH
6834688
In Commercial Distribution

  • E27668346880 ()
6834688

  • CAD/CAM software
CEREC SW 5.3 License Key Upgrade
SIRONA Dental Systems GmbH
6834670
In Commercial Distribution

  • E27668346700 ()
6834670

  • CAD/CAM software
CEREC SW 5.3 Full version dig., Primary
SIRONA Dental Systems GmbH
6834662
In Commercial Distribution

  • E27668346620 ()
6834662

  • CAD/CAM software
CEREC SW 5.3 Full version, Primary
SIRONA Dental Systems GmbH
6834654
In Commercial Distribution

  • E27668346540 ()
6834654

  • CAD/CAM software
CEREC SW 5.3 license
SIRONA Dental Systems GmbH
6834647
In Commercial Distribution

  • E27668346470 ()
6834647

  • CAD/CAM software
CEREC SW 5.3 License Upgrade Club
SIRONA Dental Systems GmbH
6834639
In Commercial Distribution

  • E27668346390 ()
6834639

  • CAD/CAM software
CEREC SW 5.2 & Pro SW-Upgrade digital
SIRONA Dental Systems GmbH
6823111
In Commercial Distribution

  • E27668231110 ()
6823111

  • CAD/CAM software
CEREC SW v5.2 licence upgrade
SIRONA Dental Systems GmbH
6823103
In Commercial Distribution

  • E27668231030 ()
6823103

  • CAD/CAM software
CEREC SW V5.3
SIRONA Dental Systems GmbH
6820893
In Commercial Distribution

  • E27668208930 ()
6820893

  • CAD/CAM software
CEREC SW v5.2 licence upgrade
SIRONA Dental Systems GmbH
6783224
In Commercial Distribution

  • E27667832240 ()


  • CAD/CAM software
CEREC SW v5.2 (full version & pro module)
SIRONA Dental Systems GmbH
6727710
In Commercial Distribution

  • E27667727710 ()


  • CAD/CAM software
CEREC SW v5.2 (licence upgrade club)
SIRONA Dental Systems GmbH
6772755
In Commercial Distribution

  • E27667727550 ()


  • CAD/CAM software
CEREC SW v5.2 (licence key upgrade)
SIRONA Dental Systems GmbH
6772722
In Commercial Distribution

  • E27667727220 ()


  • CAD/CAM software
CEREC SW v5.2 (licence)
SIRONA Dental Systems GmbH
6772714
In Commercial Distribution

  • E27667727140 ()


  • CAD/CAM software
CEREC Software Version 5.1.0 Licence Upgrade Club
SIRONA Dental Systems GmbH
6731785
In Commercial Distribution

  • E27667317850 ()


  • CAD/CAM software
CEREC Software Version 5.1.0 Upgrade
SIRONA Dental Systems GmbH
6731637
In Commercial Distribution

  • E27667316370 ()


  • CAD/CAM software
CEREC SW v5.2 (actual software)
SIRONA Dental Systems GmbH
6727460
In Commercial Distribution

  • E27667274600 ()


  • CAD/CAM software
CEREC Premium CAM 4.4.4 Software
SIRONA Dental Systems GmbH
6610591
In Commercial Distribution

  • E27666105910 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
CEREC Premium CAM 4.5.0 Software
SIRONA Dental Systems GmbH
6610443
In Commercial Distribution

  • E27666104430 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
CEREC Software Version 5.1.0 Licence
SIRONA Dental Systems GmbH
6732361
In Commercial Distribution

  • E26767323610 ()


  • CAD/CAM software
No Description
FOURNITURES HOSPITALIERES INDUSTRIE
0100011575
In Commercial Distribution

  • 03661489709067 ()


  • Orthopaedic/craniofacial implantation planning software
Holter Analysis Enhanced Plus
Northeast Monitoring, Inc.
Enhanced Plus
In Commercial Distribution

  • M581NEMK1620 ()
NEMK162

  • Cardiac arrhythmia monitoring system
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