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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CAD/CAM software
3shape A/S
2017-1
Not in Commercial Distribution

  • 05902729752510 ()


  • CAD/CAM software
The 3Shape Automate software is a web service for automatic design of crowns
3shape A/S
R1.2
In Commercial Distribution

  • 05902729753821 ()


  • Dental treatment application software
DentalSystem-backed web service for automatic designs of crowns.
3shape Trios A/S
R1.0
Not in Commercial Distribution

  • 05902729753654 ()


  • Dental treatment application software
Dental treatment application software
3shape A/S
R1.0
In Commercial Distribution

  • 05902729753555 ()


  • Dental treatment application software
Ortho System is a software system intended for use as a medical front-end for orthodontic clinics and laboratories. It supports orthodontic diagnosis, treatment planning and follow-up, CAD modelling of orthodontic appliances and indirect bonding as well as archiving of case information.
3shape A/S
85.x
In Commercial Distribution

  • 05902729753487 ()


  • Dental treatment application software
Dental treatment application software
3shape A/S
1.1.x
Not in Commercial Distribution

  • 05902729752954 ()


  • Dental treatment application software
CAD/CAM software
3shape A/S
2018-1
Not in Commercial Distribution

  • 05902729752787 ()


  • CAD/CAM software
LICENCE CS MODEL+ V5 ALIGNER CAPABILITY
Dental Imaging Technologies Corporation
594483
In Commercial Distribution

  • 00693856000302 ()
594483

  • CAD/CAM software
CEREC Ortho Software Version 2.1 Upgrade
SIRONA Dental Systems GmbH
6784495
In Commercial Distribution

  • E27667844950 ()


  • CAD/CAM software
CEREC Ortho Software Version 2.1
SIRONA Dental Systems GmbH
6748359
In Commercial Distribution

  • E27667483590 ()


  • CAD/CAM software
CEREC Ortho Software Version 2.0.0
SIRONA Dental Systems GmbH
6697986
In Commercial Distribution

  • E27666979860 ()


  • CAD/CAM software
CEREC Ortho Software Version 1.2.0
SIRONA Dental Systems GmbH
6611169
Not in Commercial Distribution

  • E27666111690 ()


  • CAD/CAM software
LICENCE CS MODEL+ V5 ALIGNER CAPABILITY
CARESTREAM DENTAL LLC
5944483
In Commercial Distribution

  • 60192155944482 ()
5944483

  • CAD/CAM software
CS MODEL+
CARESTREAM DENTAL LLC
CS Model+
Not in Commercial Distribution

  • 60192155942716 ()
5942719

  • CAD/CAM software
iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromotors, via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400052
In Commercial Distribution

  • J00714000520521 ()
1400052

  • Surgical power tool system control unit, line-powered
  • Dental treatment application software
software
Brainlab AG
1,0
In Commercial Distribution

  • 04056481141998 ()


  • Robotic surgical navigation system
Software
PRECISION BIOMETRICS INC
Feature Pack H
In Commercial Distribution

  • 00853818007477 ()


  • Bioelectrical signal analysis software
Software
PRECISION BIOMETRICS INC
Feature Pack G
In Commercial Distribution

  • 00853818007392 ()


  • Bioelectrical signal analysis software
Software
PRECISION BIOMETRICS INC
Feature Pack E
In Commercial Distribution

  • 00853818007101 ()


  • Bioelectrical signal analysis software
Software
PRECISION BIOMETRICS INC
Feature Pack D
In Commercial Distribution

  • 00853818007095 ()


  • Bioelectrical signal analysis software
Software
PRECISION BIOMETRICS INC
Feature Pack C
In Commercial Distribution

  • 00853818007088 ()


  • Bioelectrical signal analysis software
Software
PRECISION BIOMETRICS INC
Feature Pack B
In Commercial Distribution

  • 00853818007071 ()


  • Bioelectrical signal analysis software
Software
PRECISION BIOMETRICS INC
Feature Pack A
In Commercial Distribution

  • 00853818007064 ()


  • Bioelectrical signal analysis software
Software
PRECISION BIOMETRICS INC
Apricot
In Commercial Distribution

  • 00853818007057 ()


  • Bioelectrical signal analysis software
Software
AGFA
2.0
In Commercial Distribution

  • 05414904271124 ()
E5C34

  • Radiological PACS software
Software
Fujirebio Diagnostics, Inc.
CL0012
In Commercial Distribution

  • 00869164000048 ()


  • Laboratory instrument/analyser application software IVD
Software
CAPSOVISION, INC.
3
In Commercial Distribution

  • 00867770000216 ()
2759

  • Video capsule endoscopy system application software
Software
INTUITIVE SURGICAL, INC.
610140
In Commercial Distribution

  • 00886874119433 ()


  • Medical video image recorder
Software
Bard Access Systems, Inc.
Prevueplusv1.0.4.0
In Commercial Distribution

  • 00801741121852 ()
Prevueplusv1.0.4.0

  • General-purpose ultrasound imaging system
Software
Bard Access Systems, Inc.
Sherlock3cgv2.0.1
In Commercial Distribution

  • 00801741121548 ()
Sherlock3cgv2.0.1

  • Central venous catheter navigation system, electrocardiographic/magnetic
Software
Bard Access Systems, Inc.
Sherlock3cgv2.0.0
In Commercial Distribution

  • 00801741121531 ()
Sherlock3cgv2.0.0

  • Central venous catheter navigation system, electrocardiographic/magnetic
Software
Bard Access Systems, Inc.
USv1.1.1
In Commercial Distribution

  • 00801741121500 ()
USv1.1.1

  • General-purpose ultrasound imaging system
Software
Bard Access Systems, Inc.
USv1.1.0
In Commercial Distribution

  • 00801741121494 ()
USv1.1.0

  • General-purpose ultrasound imaging system
Software
Bard Access Systems, Inc.
Sherlockv1.1.1
In Commercial Distribution

  • 00801741121463 ()
Sherlockv1.1.1

  • Central venous catheter navigation system, electrocardiographic/magnetic
Software
Bard Access Systems, Inc.
Sherlockv1.1.0
In Commercial Distribution

  • 00801741121456 ()
Sherlockv1.1.0

  • Central venous catheter navigation system, electrocardiographic/magnetic
Software
Bard Access Systems, Inc.
SR8v1.0.2
In Commercial Distribution

  • 00801741121432 ()
SR8v1.0.2

  • General-purpose ultrasound imaging system
Software
Bard Access Systems, Inc.
SR8v1.0.1
In Commercial Distribution

  • 00801741121425 ()
SR8v1.0.1

  • General-purpose ultrasound imaging system
Software
Bard Access Systems, Inc.
Sherlock3CGv2.1.0
In Commercial Distribution

  • 00801741129469 ()
Sherlock3CGv2.1.0

  • Central venous catheter navigation system, electrocardiographic/magnetic
Software
DEXIS LLC
11
In Commercial Distribution

  • EKAV101244750 ()
1.012.4475

  • Radiology information system application software
Software
DEXIS LLC
11
In Commercial Distribution

  • EKAV101135330 ()
10124479

  • Radiology information system application software
SOFTWARE, CODE-STAT CASEVIEW SOFTWARE INSTALL
PHYSIO-CONTROL, INC.
21340
In Commercial Distribution

  • 00883873837788 ()
21340-000850

  • Medical equipment clinical data interfacing software
BRACKET 9735354 ZEISS PENTERO TOOLS DB
MEDTRONIC NAVIGATION, INC.
9735354
In Commercial Distribution

  • 00643169363878 ()


  • Multi-purpose stereotactic surgery system
BRACKET 9735352 NC4 LED TOOLS DB
MEDTRONIC NAVIGATION, INC.
9735352
In Commercial Distribution

  • 00643169363854 ()


  • Multi-purpose stereotactic surgery system
TRACKER 9735357 ACTV WIRELESS TOOLS DB
MEDTRONIC NAVIGATION, INC.
9735357
In Commercial Distribution

  • 00643169363830 ()


  • Multi-purpose stereotactic surgery system
BRACKET 9735355 ZEISS VARIO TOOLS DB
MEDTRONIC NAVIGATION, INC.
9735355
In Commercial Distribution

  • 00643169363816 ()


  • Multi-purpose stereotactic surgery system
BRACKET 9735356 LEICA MSCOPE TOOLS DB
MEDTRONIC NAVIGATION, INC.
9735356
In Commercial Distribution

  • 00643169363823 ()


  • Multi-purpose stereotactic surgery system
TOOLS AND FILLER EL153B LARGE KIT
MEDTRONIC SOFAMOR DANEK, INC.
EL153B
In Commercial Distribution

  • 00643169110212 ()

  • Extremities, Large Kit Assy, US, 15/3


  • Balloon kyphoplasty kit
TOOLS AND FILLER ES103B SMALL KIT
MEDTRONIC SOFAMOR DANEK, INC.
ES103B
In Commercial Distribution

  • 00643169157255 ()

  • Extremities, Small Kit Assy, US, 10/3


  • Balloon kyphoplasty kit
TOOLS AND FILLER EL153B LARGE KIT
MEDTRONIC SOFAMOR DANEK, INC.
EL153B
In Commercial Distribution

  • 00643169157248 ()

  • Extremities, Large Kit Assy, US, 15/3


  • Balloon kyphoplasty kit
REMOVAL SCREW FOR ABUTMENT - SEATING TOOLS
ACE SURGICAL SUPPLY CO., INC.
20957401
In Commercial Distribution

  • 00614950030101 ()
20957401

  • Dental prosthesis/implant abutment screw analog, single-use
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