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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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QUANTUM™* FLEX - 00846468022389

ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-120
Not in Commercial Distribution

  • 00846468022389 ()


  • Bone-screw internal spinal fixation system, non-sterile

QUANTUM™* FLEX - 00846468022372

ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-110
Not in Commercial Distribution

  • 00846468022372 ()


  • Bone-screw internal spinal fixation system, non-sterile

QUANTUM™* FLEX - 00846468022365

ROD, PRE-BENT
Pioneer Surgical Technology, Inc.
13-55-PR-100
Not in Commercial Distribution

  • 00846468022365 ()


  • Bone-screw internal spinal fixation system, non-sterile

Quantum Intersegmental Table - 00850020142415

No Description
PIVOTAL HEALTH SOLUTIONS, INC.
Q400
In Commercial Distribution

  • 00850020142415 ()


  • Traction table, line-powered

Quantum 6000Z HD - 00606509200110

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 6000ZHD/Q6000ZHD/Q600 HD
In Commercial Distribution

  • 00606509200110 ()
N/A

  • Electric-motor-driven wheelchair, occupant-controlled

Quantum Mitohormesis (QMT) - 08885022060018

Quantum Mitohormesis (QMT) Medical Device is intended for: 1. Stimulating healthy limb muscles to improve and facilitate muscle performance. 2. Preventing or retardation of disuse atrophy of muscles.
QUANTUMTX PTE. LTD.
M2101
In Commercial Distribution

  • 18885022060015 ()
  • 08885022060018 ()


  • Muscle performance enhancement electromagnetic stimulator

16 Ch AI BREAST COIL 1.5T - 04260487680034

No Description
RAPID Biomedical GmbH
10185781 02
In Commercial Distribution

  • 04260487680034 ()


  • MRI system coil, radio-frequency

PowerLook AI Mammo Container 1.0.0 Blackford - 00850008977534

No Description
Icad, Inc.
DSC036-01
In Commercial Distribution

  • 00850008977534 ()


  • Radiology DICOM image processing application software

Caption AI (Caption Guidance + Caption Interpretation) - 00860003586341

No Description
CAPTION HEALTH, INC.
Alastor
Not in Commercial Distribution

  • 00860003586341 ()


  • Ultrasound imaging system application software

Caption AI (Caption Guidance + Caption Interpretation) - 00860003586310

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
Not in Commercial Distribution

511-00019

  • Ultrasound imaging system application software
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