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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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POSTERIOR CERVICAL, ROD, STRAIGHT, CoCr, 3.5 X 80, Co 28Cr 6Mo
Innovasis, Inc.
05-002-10-3508
In Commercial Distribution

  • M711050021035080 ()

  • Length: 80 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Bone-screw internal spinal fixation system rod
WIN
TORNIER
BPUE001
In Commercial Distribution

  • 03700434023114 ()
4.1.Win

  • Orthopaedic CAD/CAM system
MAC
TORNIER
BPUE001
In Commercial Distribution

  • 03700434023107 ()
4.1.Mac

  • Orthopaedic CAD/CAM system
Mac
TORNIER
BPUE001
In Commercial Distribution

  • 03700434015065 ()
4.0.Mac

  • Orthopaedic CAD/CAM system
Win
TORNIER
BPUE001
In Commercial Distribution

  • 03700434015058 ()
4.0.Win

  • Orthopaedic CAD/CAM system
No Description
CAPTION HEALTH, INC.
Alastor
In Commercial Distribution

  • 00860003586341 ()


  • Ultrasound imaging system application software
Caption AI (Caption Guidance + Caption Interpretation) on portable handheld ultrasound. The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2DTTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5- Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC). The Caption Interpretation Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation. The Caption Interpretation Automated Ejection Fraction Software is indicated for use in adult patients.
CAPTION HEALTH, INC.
Adonis
In Commercial Distribution

511-00019

  • Ultrasound imaging system application software
The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2DTTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5- Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC). The Caption Interpretation Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation. The Caption Interpretation Automated Ejection Fraction Software is indicated for use in adult patients.
CAPTION HEALTH, INC.
0.10, 0.11, 1.1, 1.2, 1.3, 1.4
Not in Commercial Distribution

  • 00860003586303 ()
511-00003

  • Ultrasound imaging system application software
Multi-link cable for connecting data acquisition unit
NIHON KOHDEN CORPORATION
YS-096P5
In Commercial Distribution

  • 04931921114742 ()
YS-096P5

  • General-purpose multi-parameter bedside monitor
Multi-link cable for connecting data acquisition unit
NIHON KOHDEN AMERICA, INC.
YS-096P5
In Commercial Distribution

  • 00841983101885 ()
YS-096P5

  • General-purpose multi-parameter bedside monitor
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