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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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AEON-C Stand Alone; TAV/TAV; 12x14; 15deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039836814 ()
CSAT2.12141505

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; TAV/TAV; 12x14; 0deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039836593 ()
CSAT2.12140005

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 0deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039834940 ()
CSA.14160005

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 12x16; 0deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039834728 ()
CSA.12160005

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 15x18; 7deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039838467 ()
CSAS.15180705

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 15deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039838245 ()
CSAS.14161505

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 7deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039838139 ()
CSAS.14160705

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 12x14; 0deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039837804 ()
CSAS.12160005

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; TAV/TAV; 12x14; 7deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039836708 ()
CSAT2.12140705

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 15x18; 15deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835497 ()
CSA.15181505

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 15x18; 7deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835381 ()
CSA.15180705

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 15x18; 0deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835275 ()
CSA.15180005

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 15deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835169 ()
CSA.14161505

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 7deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835053 ()
CSA.14160705

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 12x16; 7deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039834834 ()
CSA.12160705

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 12x14; 7deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039834612 ()
CSA.12140705

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 12x14; 0deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039834506 ()
CSA.12140005

  • Spinal fixation plate, non-bioabsorbable
DISTRACTOR L14 x W16 x A7 x H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039831017 ()
AC.0554

  • Spinal fixation plate, non-bioabsorbable
DISTRACTOR L12 x W14 x A7 x H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039830959 ()
AC.0546

  • Spinal fixation plate, non-bioabsorbable
SV1/H56 SAVANNAH 1/H5 #6 HDL 1P
Peter Brasseler Holdings, LLC
5023453U0
In Commercial Distribution

  • 00887919682509 ()


  • Manual dental scaler, reusable
SH5/U156 H5/U15 SCAL #6 HDL 1P
Peter Brasseler Holdings, LLC
5023411U0
In Commercial Distribution

  • 00887919682080 ()


  • Manual dental scaler, reusable
SH5/H5S6 H5/H5S SCAL #6 HDL 1P
Peter Brasseler Holdings, LLC
5023410U0
In Commercial Distribution

  • 00887919682073 ()


  • Manual dental scaler, reusable
SH5/486 H5/48 SCAL #6 HDL 1P
Peter Brasseler Holdings, LLC
5023408U0
In Commercial Distribution

  • 00887919682059 ()


  • Manual dental scaler, reusable
SH5/336 H5/33 SCAL #6 HDL 1P
Peter Brasseler Holdings, LLC
5023406U0
In Commercial Distribution

  • 00887919682035 ()


  • Manual dental scaler, reusable
WT Novaloc® TiN, angled 15°, H5, TAV
Institut Straumann AG
Edentulous Abutments
In Commercial Distribution

  • 07630031752918 ()

  • Height: 5 Millimeter
  • Angle: 15 degree
037.2533

  • Dental implant suprastructure, permanent, preformed
RT Novaloc® TiN, angled 15°, H5, TAV
Institut Straumann AG
Edentulous Abutments
In Commercial Distribution

  • 07630031752901 ()

  • Angle: 15 degree
  • Height: 5 Millimeter
037.1533

  • Dental implant suprastructure, permanent, preformed
NT Novaloc® TiN, angled 15°, H5, TAV
Institut Straumann AG
Edentulous Abutments
In Commercial Distribution

  • 07630031752895 ()

  • Angle: 15 degree
  • Height: 5 Millimeter
037.0533

  • Dental implant suprastructure, permanent, preformed
WT Novaloc® TiN, straight 0°, H5, TAV
Institut Straumann AG
Edentulous Abutments
In Commercial Distribution

  • 07630031752765 ()

  • Height: 5 Millimeter
037.2524

  • Dental implant suprastructure, permanent, preformed
RT Novaloc® TiN, straight 0°, H5, TAV
Institut Straumann AG
Edentulous Abutments
In Commercial Distribution

  • 07630031752758 ()

  • Height: 5 Millimeter
037.1524

  • Dental implant suprastructure, permanent, preformed
NT Novaloc® TiN, straight 0°, H5, TAV
Institut Straumann AG
Edentulous Abutments
In Commercial Distribution

  • 07630031752741 ()

  • Height: 5 Millimeter
037.0524

  • Dental implant suprastructure, permanent, preformed
SCALER # H5/33 (ONYX COLLECTION) (US ALLOY N664)
POMEE CORPORATION
711-533OC
In Commercial Distribution

  • G157711533OC0 ()
711-533OC

  • Manual dental scaler, reusable
M10345 - Salmonella Monovalent H Antiserum - Factor H-5 - 2ml
MAST GROUP LIMITED
M10345
In Commercial Distribution

  • 15060392375881 ()
M10345

  • Multiple Salmonella species culture isolate antigen IVD, kit, agglutination
SW, EXE, Lifeline Response Smart Phone Application, Google
Lifeline Systems Company
300000161331
Not in Commercial Distribution

  • 00884838082137 ()
mSafe

  • Vulnerable patient home alert system
SW, EXE, Lifeline Response Smart Phone Application, Apple
Lifeline Systems Company
300000161311
Not in Commercial Distribution

  • 00884838082120 ()
mSafe

  • Vulnerable patient home alert system
No Description
Ventric Health
VA 1.0
In Commercial Distribution

  • 00850044849024 ()


  • Cardiac mapping system application software
MapRT is used to assist treatment planning whereby the patient surface and positioning devices captured at simulation can be modelled against the treatment devices, such that any potential collisions can be predicted.
VISION RT LIMITED
MapRT Web app 1.1
In Commercial Distribution

  • 05056190500887 ()
MapRT Web app

  • Radiation therapy software
MapRT is used to assist treatment planning whereby the patient surface and positioning devices captured at simulation can be modelled against the treatment devices, such that any potential collisions can be predicted.
VISION RT LIMITED
MapRT Web app
In Commercial Distribution

  • 05056190500771 ()
MapRT Web app

  • Radiation therapy software
physIQ Medical Device Data System Android App
PHYSIQ, INC
3.4 (Edison)
In Commercial Distribution

  • 00860004366218 ()


  • Electrocardiography telemetric monitoring system
This is an application intended to be used by neurologists who are monitoring or reviewing EEGs. It is part of a larger system provided by Persyst.
Persyst Development Corp
App for Web
Not in Commercial Distribution

  • 00869732000142 ()


  • Bioelectrical signal analysis software
The Persyst Mobile App is a software application that can be executed on a mobile platform. It is capable of displaying the original EEG data, and quantitative analysis of EEG data generated by the Persyst EEG Review and Analysis Software. This Mobile App is intended to be used by qualified medical practitioners who will exercise professional judgement in using the information.
Persyst Development Corp
Persyst Mobile App
In Commercial Distribution

  • 00869732000135 ()


  • Bioelectrical signal analysis software
No Description
Garmin International, Inc.
1.x
In Commercial Distribution

  • 00860009117716 ()


  • Cardiopulmonary physiological parameter analysis software
No Description
Garmin International, Inc.
1.x
In Commercial Distribution

  • 00860009117709 ()


  • Cardiopulmonary physiological parameter analysis software
Jacoti Listen App 2.X
Jacoti
Jacoti Listen App 2.X
In Commercial Distribution

  • 05407004250014 ()


  • Air-conduction hearing aid, wearable case
No Description
Get-Grin Inc.
W Version
In Commercial Distribution

  • D962GGAW0002 ()


  • Radiological PACS software
No Description
Get-Grin Inc.
Initial Release
In Commercial Distribution

  • D962GGAR0003 ()


  • Radiological PACS software
prolaio medical device data system mobile application
Prolaio, Inc.
DP-22-06
In Commercial Distribution

  • 00850071330007 ()


  • Electrocardiography monitoring system receiver
Windows PC Application for use with Eko products.
Eko Devices, Inc.
1.2.4
In Commercial Distribution

  • 00863609000358 ()


  • Medical equipment clinical data interfacing software
No Description
Cochlear Bone Anchored Solutions AB
P1646035
In Commercial Distribution

  • 09321502053006 ()
P1646035

  • Audiometric/hearing device software
No Description
Cochlear Bone Anchored Solutions AB
P1646054
In Commercial Distribution

  • 09321502052993 ()
P1646054

  • Audiometric/hearing device software
The Progressive Orthodontics App is an orthodontic appliance design and treatment simulation software. This software is for use by dental professionals in a healthcare facility to assist in diagnosis and design solutions for patients. Digital scans (3D) of a patient’s dentition can be loaded into the software and the dental professional can then review different treatment plans and simulations for each individual patient and decide on the most appropriate treatment.
PROGRESSIVE AMERICA, INC.
2.0
In Commercial Distribution

  • D16420251 ()


  • CAD/CAM software
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