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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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Clinical software for micro vascular assessments in physiological research and clinical applications.
MOOR INSTRUMENTS LIMITED
2
In Commercial Distribution

  • 15060484490102 ()


  • Laser Doppler blood flowmeter
The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The EVA System is a mobile colposcope in which a smartphone is fitted and consists of a colposcope body, lens, smartphone upper and lower brackets, LED electronics, a mobile app for image capture, and online portal for image transfer and remote viewing. The device is intended for use in hospitals, doctor's offices and remote and rural clinics.
MOBILEODT LTD
2
In Commercial Distribution

  • 17290016976004 ()


  • Colposcope
No Description
Directa AB
2
In Commercial Distribution

  • 17310236092091 ()
609209

  • Preformed dental crown, temporary
Sleep disorder interpretive software, professional-only
OXEHEALTH LIMITED
2
In Commercial Distribution

  • 50607514500023 ()


  • Sleep disorder interpretive software, professional-only
Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And Respiratory Rate
OXEHEALTH LIMITED
2
In Commercial Distribution

  • 50607514500009 ()


  • Near-infrared camera vital sign measurement software
No Description
GE MEDICAL SYSTEMS, INC.
2
In Commercial Distribution

  • 00840682142601 ()


  • CT system application software
American Sleep Dentistry's Mezzo Omni Oral Appliance version 2 is an oral appliance designed to treat sleep apnea. This appliances is two dental splints connected mezzolaterally by an adjustable permanent attachment. The attachmentallows the patient to adjust the mandibular articulation either forward (protension) or backward (retension). The Mezzo Omni features a lower profile designed to be worn more comfortably that prior oral attachments.
ASD SLEEP, LLC
2
In Commercial Distribution

  • D156MO2 ()

  • Height: 1 Inch
  • Width: 4 Inch
  • Depth: 4 Inch
MO2

  • Mandible-repositioning sleep-disordered breathing orthosis
Loop-X Mobile Imaging Robot: Mobile (within an imaging facility) assembly of diagnostic x-ray computed tomography (CT) and fluoroscopic devices intended to acquire, display and process both: 1) two- and/or three-dimensional (3-D) cross-sectional (tomographic) images; and 2) real-time fluoroscopic images, from any part of the body for a variety of applications.
medPhoton GmbH
2
In Commercial Distribution

  • 19120075320129 ()
P04-2

  • Multi-modality diagnostic x-ray system, mobile
ImagingRing m, Version 2: Mobile (within an imaging facility) assembly of diagnostic x-ray computed tomography (CT) and fluoroscopic devices intended to acquire, display and process both: 1) two- and/or three-dimensional (3-D) cross-sectional (tomographic) images; and 2) real-time fluoroscopic images, from any part of the body for a variety of applications.
medPhoton GmbH
2
In Commercial Distribution

  • 19120075320112 ()
P04-1

  • Multi-modality diagnostic x-ray system, mobile
No Description
Everly Health, Inc.
2
In Commercial Distribution

  • G7323001 ()


  • Oral/respiratory tract specimen container IVD, no additive/medium
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