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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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No Description
Medical Measurement Systems B.V.
G3-14
In Commercial Distribution

  • 08717775955009 ()


  • Gastroduodenal motility analysis system
No Description
Medical Measurement Systems B.V.
MPP-FR0.15T XL
In Commercial Distribution

  • 08717775954798 ()


  • Gastroduodenal motility analysis system
No Description
Medical Measurement Systems B.V.
MPP-FR0.6T
In Commercial Distribution

  • 08717775953364 ()
  • 08717775956242 ()


  • Gastroduodenal motility analysis system
No Description
Medical Measurement Systems B.V.
MPP-FR0.15T
In Commercial Distribution

  • 08717775953357 ()
  • 08717775956259 ()


  • Gastroduodenal motility analysis system
No Description
Medical Measurement Systems B.V.
MPP-T
In Commercial Distribution

  • 08717775951087 ()


  • Gastroduodenal motility analysis system
No Description
ILOODA.CO.,LTD
RetiCapture
In Commercial Distribution

  • 08800023201017 ()


  • Ophthalmic fundus camera
Retina 800 is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent
ESSILOR INTERNATIONAL
RET1IN
In Commercial Distribution

  • 03615020000465 ()


  • Ophthalmic fundus camera
Retina 400 is an electromedical system that allows for digitally retrieving, acquiring and processing of a retinal image, for use in ophthalmological diagnosis by medical specialists, and other uses inherent to the professional activity of other operators, optometrists and opticians, to the extent permitted by the laws and regulations for the exercise of their profession. An absolute new entry in the field for retinal imaging, the instrument allows for a direct, "live" monitoring on the computer screen, and capturing also in cases where the pupil diameter is extremely narrow. The instrument, with manual acquisition and electronically guided control, guarantees high precision and repeatability of the measurements.
ESSILOR INTERNATIONAL
RETINA 400
In Commercial Distribution

  • 03615020000267 ()


  • Ophthalmic fundus camera
Camera, Ophthalmic, ac-powered
Retina-Ai Health, Inc.
100
In Commercial Distribution

  • B857000 ()


  • Ophthalmic fundus camera
PRESSIO SERIAL TRANSMITTER
SOPHYSA
PSO-TX00
Not in Commercial Distribution

  • 03760124131512 ()


  • Patient monitoring system module, intracranial pressure
PRESSIO ICP INTERFACE CONTROL UNIT
SOPHYSA
PSO-IN00
Not in Commercial Distribution

  • 03760124131499 ()


  • Patient monitoring system module, intracranial pressure
No Description
Aural Analytics, Inc.
SDK
Not in Commercial Distribution

  • 00196852685837 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
MSPT-30
Not in Commercial Distribution

  • 00195893702190 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
MSPT-W30
Not in Commercial Distribution

  • 00195893329458 ()


  • Cognitive assessment software
No Description
Carl Zeiss Meditec AG
302721-9030-000
In Commercial Distribution

  • 04049539072030 ()


  • Ophthalmic fundus camera
No Description
Carl Zeiss Meditec AG
302721-9020-000
In Commercial Distribution

  • 04049539072023 ()


  • Ophthalmic fundus camera
The VISUCAM Digital Fundus Camera is suitable for photographing, displaying and storing data relating to the retina and surrounding parts of the eye beeing examined under mydriatic and non-mydriatic conditions. These photographs assist with the diagnosis and follow-up of eye diseases, which can be visually monitored and photographiacally documented.
Carl Zeiss Meditec AG
VISUCAM 524
In Commercial Distribution

  • 04049471093162 ()

  • Weight: 36 Kilogram
  • Dimension: approx. 400mmx500mmx730mm


  • Ophthalmic fundus camera
The VISUCAM Digital Fundus Camera is suitable for photographing, displaying and storing data relating to the retina and surrounding parts of the eye beeing examined under mydriatic and non-mydriatic conditions. These photographs assist with the diagnosis and follow-up of eye diseases, which can be visually monitored and photographiacally documented.
Carl Zeiss Meditec AG
VISUCAM 224
In Commercial Distribution

  • 04049471093155 ()

  • Dimension: approx. 400mmx500mmx730mm
  • Weight: 36 Kilogram


  • Ophthalmic fundus camera
The FF 450plus is a monocular retina camera for routine use. It is designed to capture images of the eye, especially the retina area, as well as surrounding areas, to aid diagnosing or monitoring diseases of the eye that may be observed and photographed. If used in combination with dedicated optional equipment (electronic image sensors, digital archiving system) the system allows images to be displayed, stored, manipulated and archived digitally.
Carl Zeiss Meditec AG
FF450plus
In Commercial Distribution

  • 04049471093032 ()

  • Dimension Fundus Camera: approx. 310mmx800mmx430mm
  • Dimension NAG: 132mmx440mmx360mm


  • Ophthalmic fundus camera
The overall intended use of neotivCare is to provide an app-based objective measurement of cognition to quantify cognitive impairment. The software is intended for use by patients at the indication of medical professionals to quantify and monitor a suspected or self-reported cognitive impairment. The app is not intended as a standalone diagnostic assessment and is only indicated as a tool to support the diagnostic process of a medical professional.
neotiv GmbH
1.0.0
In Commercial Distribution

  • 04262390860015 ()


  • Cognitive assessment software
No Description
CANON INC.
CR-10
In Commercial Distribution

  • 04549292228489 ()


  • Ophthalmic fundus camera
No Description
CANON INC.
imageSPECTRUM
In Commercial Distribution

  • 04549292182729 ()


  • Ophthalmic fundus camera
No Description
CANON INC.
CX-1
In Commercial Distribution

  • 04549292074345 ()


  • Ophthalmic fundus camera
No Description
CANON INC.
CR-2 Plus AF
In Commercial Distribution

  • 04549292074338 ()


  • Ophthalmic fundus camera
No Description
CANON INC.
CR-2 AF
In Commercial Distribution

  • 04549292074321 ()


  • Ophthalmic fundus camera
No Description
1BYONEPRODUCTS INC.
TMB-1585-BS
In Commercial Distribution

  • 00850014261016 ()
  • 10850014261013 ()


  • Telemetric sphygmomanometer
RetCam Envision without FA
XLTEK
61-000400
In Commercial Distribution

  • 00382830016896 ()


  • Ophthalmic fundus camera
RetCam™ Envision 80 Degree Lens
XLTEK
60-000070
In Commercial Distribution

  • 00382830062466 ()


  • Ophthalmic fundus camera
RetCam FA Upgrade Kit
XLTEK
RETCAM-FA-UPGRADE
In Commercial Distribution

  • 00382830060110 ()


  • Ophthalmic fundus camera
RetCam™ Envision Portrait Lens
XLTEK
60-000092
In Commercial Distribution

  • 00382830058681 ()


  • Ophthalmic fundus camera
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