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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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Devon - 10884521547780

3600-2Q AMSCO QUANTUM
Cardinal Health, Inc.
31146767
In Commercial Distribution

  • 10884521547780 ()
31146767

  • Medical equipment handle cover, single-use, non-sterile

QUANTUM - 03701337602987

QUANTUM BASE LEFT
IN2BONES
M05 10023
In Commercial Distribution

  • 03701337602987 ()
M05 10023

  • Instrument tray, reusable

QUANTUM - 03701337602970

QUANTUM BASE RIGHT
IN2BONES
M05 10022
In Commercial Distribution

  • 03701337602970 ()
M05 10022

  • Instrument tray, reusable

QUANTUM - 03701337602963

QUANTUM BASE GENERIC
IN2BONES
M05 10021
In Commercial Distribution

  • 03701337602963 ()
M05 10021

  • Instrument tray, reusable

QUANTUM - 03701337602895

QUANTUM BASE REVISION
IN2BONES
M05 10024
In Commercial Distribution

  • 03701337602895 ()
M05 10024

  • Instrument tray, reusable

QUANTUM - 03701337601096

QUANTUM Pin Pusher
IN2BONES USA, LLC
M05 00971
In Commercial Distribution

  • 03701337601096 ()
M05 00971

  • Orthopaedic implant impactor, reusable

QUANTUM - 03701337601089

QUANTUM Gap Sizer
IN2BONES
M05 00961
In Commercial Distribution

  • 03701337601089 ()
M05 00961

  • Surgical implant template, reusable

QUANTUM - 03701337600822

QUANTUM Insert Extractor
IN2BONES
M05 01161
In Commercial Distribution

  • 03701337600822 ()
M05 01161

  • Orthopaedic instrument extractor

QUANTUM - 03701337618926

QUANTUM BASE LEFT
IN2BONES
M05 10223
In Commercial Distribution

  • 03701337618926 ()
M05 10223

  • Instrument tray, reusable

QUANTUM - 03701337618902

QUANTUM BASE RIGHT
IN2BONES
M05 10222
In Commercial Distribution

  • 03701337618902 ()
M05 10222

  • Instrument tray, reusable

QUANTUM - 03701337618889

QUANTUM BASE GENERIC
IN2BONES
M05 10221
In Commercial Distribution

  • 03701337618889 ()
M05 10221

  • Instrument tray, reusable

QUANTUM - 03701337617851

QUANTUM IMPACTION PLATE
IN2BONES
M05 01901
In Commercial Distribution

  • 03701337617851 ()
M05 01901

  • Orthopaedic instrument surgical connector

QUANTUM - 03701337606541

QUANTUM Rack Revision
IN2BONES
M05 10014
In Commercial Distribution

  • 03701337606541 ()
M05 10014

  • Instrument tray, reusable

QUANTUM - 03701337606534

QUANTUM Rack Left
IN2BONES
M05 10013
In Commercial Distribution

  • 03701337606534 ()
M05 10013

  • Instrument tray, reusable

QUANTUM - 03701337606527

QUANTUM Rack Right
IN2BONES
M05 10012
In Commercial Distribution

  • 03701337606527 ()
M05 10012

  • Instrument tray, reusable

QUANTUM - 03701337606510

QUANTUM Rack Generic
IN2BONES
M05 10011
In Commercial Distribution

  • 03701337606510 ()
M05 10011

  • Instrument tray, reusable

Quantum - 05060434420817

Quantum Diagnostic Exhaust for use with Quantum Dagnostic Modules
SPECTRUM MEDICAL LIMITED
QDE
In Commercial Distribution

  • 05060434420817 ()
51-000051-00

  • Extracorporeal blood gas/pH monitor

Millennium - 00190776191221

AI Female Rotating FO Connector AIAI CABLE CONNECTOR
Avalign Technologies, Inc.
72-9831
In Commercial Distribution

  • 00190776191221 ()


  • Fibreoptic retractor handle

Millennium - 00190776189631

AI Swivel Instrument End ASSY DRG FTI Univ
Avalign Technologies, Inc.
M14150
In Commercial Distribution

  • 00190776189631 ()


  • Electrical-only medical device connection cable, reusable

NA - 07630031759146

Novaloc® Retention Insert Instrument, stainless steel/AI
Institut Straumann AG
Non-invasive Instruments
In Commercial Distribution

  • 07630031759146 ()
2010.741-NOV

  • Dental precision attachment fitting/adjustment tool

NA - 07630031759023

Optiloc® Retention Insert Instrument, stainless steel/AI
Institut Straumann AG
Non-invasive Instruments
In Commercial Distribution

  • 07630031759023 ()
3202.0001-OPT

  • Dental precision attachment fitting/adjustment tool

DTX Studio™ AI SDK - 07332747207422

DTX Studio AI SDK 1.0 for Windows 64-bit
Nobel Biocare AB
1
In Commercial Distribution

  • 07332747207422 ()
301913

  • Radiology DICOM image processing application software

Quantum Outback - 00606509200240

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Pride Mobility Products Corp
Quantum Outback
In Commercial Distribution

  • 00606509200240 ()
N/A

  • Electric-motor-driven wheelchair, occupant-controlled

VESALIUS Molecular Resonance Generator - 08034055291184

No Description
TELEA ELECTRONIC ENGEENERING SRL
VESALIUS QUANTUM
In Commercial Distribution

  • 08034055291184 ()
  • 08034055298190 ()
2501019

  • Electrosurgical system generator

VESALIUS Molecular Resonance Generator - 08034055290163

No Description
TELEA ELECTRONIC ENGEENERING SRL
VESALIUS QUANTUM
Not in Commercial Distribution

  • 08034055290163 ()
2501019

  • Electrosurgical system generator

VESALIUS Molecular Resonance Generator - 08034055296752

No Description
TELEA ELECTRONIC ENGEENERING SRL
VESALIUS QUANTUM
Not in Commercial Distribution

  • 08034055296752 ()
2501019

  • Electrosurgical system generator

RJL Quantum - B202QL0

No Description
R.J.L. SCIENCES, INC.
Quantum Legacy
In Commercial Distribution

  • B202QL0 ()
QL

  • Bioelectrical body composition analyser

RJL Quantum - B202QDT0

No Description
R.J.L. SCIENCES, INC.
Quantum Desktop
In Commercial Distribution

  • B202QDT0 ()
QDT

  • Bioelectrical body composition analyser

RJL Quantum - B202Q70

No Description
R.J.L. SCIENCES, INC.
Quantum 7
In Commercial Distribution

  • B202Q70 ()
Q7

  • Bioelectrical body composition analyser

CARDINAL HEALTH - 20885380096744

Cardinal Health; Crypto Giardia Control; Contains (1) 1.0mL Cryptosporidium + and (1) 1.0mL Giardia +; IVD
Cardinal Health 200, LLC
CH6870
In Commercial Distribution

  • 50885380096745 ()
  • 20885380096744 ()
  • 10885380096747 ()
CH6870

  • Multiple faecal parasite antigen IVD, kit, rapid ICT, clinical

RBknee - 05700002173614

No Description
Radiobotics ApS
v.1.
In Commercial Distribution

  • 05700002173614 ()


  • X-ray image interpretive software

Imbio PHA - 00850894007902

The PHA Software is a set of medical image post-processing computer algorithms that together perform automated image segmentation and diameter measurements on computed tomography pulmonary angiography (CTPA) images. The device then reports the ratio of those diameter measurements. The PHA Software is a single command-line executable program that may be run directly from the command-line or through scripting and thus the user interface is minimal.
Imbio, LLC
4.0.0
In Commercial Distribution

  • 00850894007902 ()


  • X-ray image interpretive software

Imbio RV/LV - 00850894007766

The Imbio CT RV/LV Software is a set of medical image post-processing computer algorithms that together perform automated image segmentation and diameter measurements on computed tomography pulmonary angiography (CTPA) images. The device then reports the ratio of those diameter measurements. The Imbio CT RV/LV Software is a single command-line executable program that may be run directly from the command-line or through scripting and thus the user interface is minimal.
Imbio, LLC
3.1.1
In Commercial Distribution

  • 00850894007766 ()


  • X-ray image interpretive software

Imbio RV/LV - 00850894007728

The Imbio CT RV/LV Software is a set of medical image post-processing computer algorithms that together perform automated image segmentation and diameter measurements on computed tomography pulmonary angiography (CTPA) images. The device then reports the ratio of those diameter measurements. The Imbio CT RV/LV Software is a single command-line executable program that may be run directly from the command-line or through scripting and thus the user interface is minimal.
Imbio, LLC
3.1.0
In Commercial Distribution

  • 00850894007728 ()


  • X-ray image interpretive software

Imbio RV/LV - 00850894007643

The Imbio CT RV/LV Software is a set of medical image post-processing computer algorithms that together perform automated image segmentation and diameter measurements on computed tomography pulmonary angiography (CTPA) images. The device then reports the ratio of those diameter measurements. The Imbio CT RV/LV Software is a single command-line executable program that may be run directly from the command-line or through scripting and thus the user interface is minimal.
Imbio, LLC
3.0.0
In Commercial Distribution

  • 00850894007643 ()


  • X-ray image interpretive software

Imbio RV/LV - 00850894007636

The Imbio CT RV/LV Software is a set of medical image post-processing computer algorithms that together perform automated image segmentation and diameter measurements on computed tomography pulmonary angiography (CTPA) images. The device then reports the ratio of those diameter measurements. The Imbio CT RV/LV Software is a single command-line executable program that may be run directly from the command-line or through scripting and thus the user interface is minimal.
Imbio, LLC
2.1
In Commercial Distribution

  • 00850894007636 ()


  • X-ray image interpretive software

Imbio RV/LV - 00850894007605

The Imbio CT RV/LV Software is a set of medical image post-processing computer algorithms that together perform automated image segmentation and diameter measurements on computed tomography pulmonary angiography (CTPA) images. The device then reports the ratio of those diameter measurements. The Imbio CT RV/LV Software is a single command-line executable program that may be run directly from the command-line or through scripting and thus the user interface is minimal.
Imbio, LLC
2.0
In Commercial Distribution

  • 00850894007605 ()


  • X-ray image interpretive software

e-Lung - B720BX360ELUNG220

No Description
BRAINOMIX LIMITED
2.2
In Commercial Distribution

  • B720BX360ELUNG220 ()


  • X-ray image interpretive software

Rho - 06287194090220

Rho radiology software for opportunistic evaluation of low bone mineral density.
16 Bit Inc.
Rho
In Commercial Distribution

  • 06287194090220 ()


  • X-ray image interpretive software

Chest-CAD - 00852491008023

Chest-CAD is a computer-assisted detection (CADe) software device designed as a concurrent reading aid to physicians. Chest-CAD uses machine learning techniques to identify, highlight, and categorize suspicious regions of interest (ROI) in adult chest X-rays. Any suspicious ROI identified by Chest-CAD is assigned to one of the following categories: Cardiac, Mediastinum/Hila, Lungs, Pleura, Bones, Soft Tissues, Hardware, or Other. 00852491008016
Imagen Technologies, Inc.
1.0.0
In Commercial Distribution

  • 00852491008023 ()


  • X-ray image interpretive software
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