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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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KOWA VX-10a - 04987646804147

KOWA VX-10a is intended for taking pictures of fundus images with mydriatic or without mydriatic.
KOWA COMPANY,LTD.
K9L48BK
In Commercial Distribution

  • 04987646804147 ()

  • Height: 620 Millimeter
  • Depth: 520 Millimeter
  • Width: 400 Millimeter
  • Weight: 35.5 Kilogram


  • Ophthalmic fundus camera

KOWA GENESIS-D - 04987646803973

The Kowa hand-held retinal camera, KOWA GENESIS-D is a device intended to capture and save fundus images with mydriatic.
KOWA COMPANY,LTD.
K9L51K
In Commercial Distribution

  • 04987646803973 ()

  • Power supply unit Weight: 1930Grams, Width: 180mm, Depth: 300mm, Height: 230mm
  • Camera unit Weight: 1070 Grams, Width: 74.5mm, Depth: 197mm, Height: 278.5mm


  • Ophthalmic fundus camera

KOWA VX-10 - 04987646802006

KOWA VX-10 is intended for taking pictures of fundus images with mydriatic or without mydriatic.
KOWA COMPANY,LTD.
K9L48K
In Commercial Distribution

  • 04987646802006 ()

  • Height: 620 Millimeter
  • Depth: 520 Millimeter
  • Width: 400 Millimeter
  • Weight: 39 Kilogram


  • Ophthalmic fundus camera

KOWA nonmyd a-DIII - 04987646800606

KOWA nonmyd a-DIII, fundus camera, is intended for use with retinal image capturing without mydriatic. The retinal image can be stored to an image filing drive through serial interface.
KOWA COMPANY,LTD.
K9L58K
In Commercial Distribution

  • 04987646800606 ()

  • Height: 462 Millimeter
  • Depth: 505 Millimeter
  • Width: 310 Millimeter
  • Weight: 22 Kilogram


  • Ophthalmic fundus camera

KOWA GENESIS-Df - 04987646800583

KOWA GENESIS-Df is a device intended to capture and save fundus images with mydriatic.
KOWA COMPANY,LTD.
K9L51BK
In Commercial Distribution

  • 04987646800583 ()

  • Power supply unit Weight: 1930Grams, Width: 180mm, Depth: 300mm, Height: 230mm
  • Camera unit Weight: 1070Grams, Width: 74.5mm, Depth: 197mm, Height: 278.5mm


  • Ophthalmic fundus camera

DIGITAL MEDICAL SCOPE - 04987669101087

NIDEK DS-20 is a digital hand-held eye-fundus camera used to record digital photographs and video of fundus (including retina, macula and optic disc) of the human eye and surrounding area. DS-20 consists of control unit and optical lens DS-20F (Digital Eye Fundus Camera).
NIDEK CO.,LTD.
DS-20 Control Unit
In Commercial Distribution

  • 04987669101087 ()


  • Ophthalmic fundus camera

DIGITAL MEDICAL SCOPE - 04987669101001

NIDEK DS-20 is a digital hand-held eye-fundus camera used to record digital photographs and video of fundus (including retina, macula and optic disc) of the human eye and surrounding area.
NIDEK CO.,LTD.
DS-20F
In Commercial Distribution

  • 04987669101001 ()


  • Ophthalmic fundus camera

DIGITAL MEDICAL SCOPE - 04987669100998

NIDEK DS-10F is a digital hand-held eye-fundus camera used to record digital photographs and video of fundus (including retina, macula and optic disc) of the human eye and surrounding area.
NIDEK CO.,LTD.
DS-10F
In Commercial Distribution

  • 04987669100998 ()


  • Ophthalmic fundus camera

Vitazi View™ - 04719876420398

Automated Portable Retinal Camera
CRYSTALVUE MEDICAL CORPORATION
VitaziView
In Commercial Distribution

  • 04719876420398 ()
700-C2701-431

  • Ophthalmic fundus camera

Halo - 04719876420275

Automated Portable Retinal Camera
CRYSTALVUE MEDICAL CORPORATION
Halo
In Commercial Distribution

  • 04719876420275 ()
700-C2701-131

  • Ophthalmic fundus camera

NFC-600 - 04719876420268

Automated Portable Retinal Camera
CRYSTALVUE MEDICAL CORPORATION
NFC-600
In Commercial Distribution

  • 04719876420268 ()
700-C2701-031

  • Ophthalmic fundus camera

Polaris - 04719876420176

Non-Mydriatic Auto Fundus Camera
CRYSTALVUE MEDICAL CORPORATION
Polaris
In Commercial Distribution

  • 04719876420176 ()
700-C1101-431

  • Ophthalmic fundus camera

RetinaStation - 04719876420060

Non-Mydriatic Auto Fundus Camera
CRYSTALVUE MEDICAL CORPORATION
RetinaStation
In Commercial Distribution

  • 04719876420060 ()
700-C1101-231

  • Ophthalmic fundus camera

NFC-700 - 04719876420053

Non-Mydriatic Auto Fundus Camera
CRYSTALVUE MEDICAL CORPORATION
NFC-700
In Commercial Distribution

  • 04719876420053 ()
700-C1101-031

  • Ophthalmic fundus camera

Welch Allyn - 04719872711162

Eye Fundus Camera: RetinaVue 700 Imager (RV700-B)
MEDIMAGING INTEGRATED SOLUTION INC.
1008
In Commercial Distribution

  • 04719872711162 ()


  • Ophthalmic fundus camera

Welch Allyn - 04719872711155

Eye Fundus Camera: RetinaVue 700 Imager (RV700TUD-B)
MEDIMAGING INTEGRATED SOLUTION INC.
1008
In Commercial Distribution

  • 04719872711155 ()


  • Ophthalmic fundus camera

Welch Allyn - 04719872711148

Eye Fundus Camera: RetinaVue 700 Imager (RV700TU-B)
MEDIMAGING INTEGRATED SOLUTION INC.
1008
In Commercial Distribution

  • 04719872711148 ()


  • Ophthalmic fundus camera

Welch Allyn - 04719872711131

Eye Fundus Camera: RetinaVue 700 Imager (RV700B)
MEDIMAGING INTEGRATED SOLUTION INC.
1008
In Commercial Distribution

  • 04719872711131 ()


  • Ophthalmic fundus camera

Welch Allyn - 04719872711124

Eye Fundus Camera: RetinaVue 100 Imager (RV100PRO-C)
MEDIMAGING INTEGRATED SOLUTION INC.
1007
In Commercial Distribution

  • 04719872711124 ()


  • Ophthalmic fundus camera

Welch Allyn - 04719872711117

Eye Fundus Camera: RetinaVue 100 Imager (RV100PROC)
MEDIMAGING INTEGRATED SOLUTION INC.
1007
In Commercial Distribution

  • 04719872711117 ()


  • Ophthalmic fundus camera

CLARUS - 04057748096044

The CLARUS 700 is an active, non-contact, software controlled, high resolution imaging device for in-vivo imaging of the human eye.The CLARUS 700 ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view. The CLARUS 700 angiography is indicated as an aid in the visualization of vascular structures of the retina and the choroid.
Carl Zeiss Meditec, Inc.
700
In Commercial Distribution

  • 04057748096044 ()


  • Ophthalmic fundus camera

CLARUS - 04057748096051

The CLARUS is an active, non-contact, software controlled, high resolution imaging device for in-vivo imaging of the human eye. The CLARUS ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view. The CLARUS Review Software can be installed on a separate review station (PC or laptop) for data review and analysis.
Carl Zeiss Meditec, Inc.
CLARUS Review Software
In Commercial Distribution

  • 04057748096051 ()


  • Ophthalmic fundus camera

CLARUS - 04057748096037

The CLARUS 500 is an active, non-contact, software controlled, high resolution imaging device for in-vivo imaging of the human eye. The CLARUS 500 ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view.
Carl Zeiss Meditec, Inc.
500
In Commercial Distribution

  • 04057748096037 ()


  • Ophthalmic fundus camera

Speech Vitals - Cognition - 00196852685837

No Description
Aural Analytics, Inc.
SDK
Not in Commercial Distribution

  • 00196852685837 ()


  • Cognitive assessment software

RetCam Portable - 00899281002137

The RetCam Portable Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye.
CLARITY MEDICAL SYSTEMS, INC.
RetCam Portable
Not in Commercial Distribution

  • 00899281002137 ()


  • Ophthalmic fundus camera

RetCam Shuttle - 00899281002120

The RetCam Shuttle Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye.
CLARITY MEDICAL SYSTEMS, INC.
RetCam Shuttle
Not in Commercial Distribution

  • 00899281002120 ()


  • Ophthalmic fundus camera

RetCam 3 - 00899281002113

RetCam 3 Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye.
CLARITY MEDICAL SYSTEMS, INC.
RetCam 3
Not in Commercial Distribution

  • 00899281002113 ()


  • Ophthalmic fundus camera

PROTOZ - B667PROTOZ1

ProtoZ is the Nexy device (an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent) with different outline colors.
NEXT SIGHT SRL
01
In Commercial Distribution

  • B667PROTOZ01 ()
  • B667PROTOZ1 ()


  • Ophthalmic fundus camera

NEXY - B667NEXY1

Nexy device is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent.
NEXT SIGHT SRL
01
In Commercial Distribution

  • B667NEXY01 ()
  • B667NEXY1 ()


  • Ophthalmic fundus camera

Core Cognitive Evaluation - B626200050

No Description
Linus Health, Inc.
20005
In Commercial Distribution

  • B626200050 ()
20005

  • Cognitive assessment software

Research Platform - B626200020

No Description
Linus Health, Inc.
20002
Not in Commercial Distribution

  • B626200020 ()


  • Cognitive assessment software

Core Cognitive Evaluation - B626200010

Core Cognitive Evaluation is a non-invasive test that assess possible cognitive impairment. It is intended to be used by medical professionals qualified to interpret results of a cognitive assessment.
Linus Health, Inc.
20001
Not in Commercial Distribution

  • B626200010 ()
20001

  • Cognitive assessment software

Buxton BioMedical - B7687211010

Penfield 1 Cup/Dissector
Buxton Biomedical Inc
72-1101
In Commercial Distribution

  • B7687211010 ()
72-1101

  • Telemetric sphygmomanometer

MPP-A - 08717775951964

No Description
Medical Measurement Systems B.V.
MPP-A
In Commercial Distribution

  • 08717775951964 ()


  • Gastroduodenal motility analysis system

MPP-T - 08717775951087

No Description
Medical Measurement Systems B.V.
MPP-T
In Commercial Distribution

  • 08717775951087 ()


  • Gastroduodenal motility analysis system

MPP-F - 08717775951070

No Description
Medical Measurement Systems B.V.
MPP-F
In Commercial Distribution

  • 08717775951070 ()
  • 08717775956235 ()


  • Gastroduodenal motility analysis system

MPP-Kit36 - 08717775956228

No Description
Medical Measurement Systems B.V.
MPP-Kit36
In Commercial Distribution

  • 08717775956228 ()


  • Gastroduodenal motility analysis system

MPP-Kit24 - 08717775956211

No Description
Medical Measurement Systems B.V.
MPP-Kit24
In Commercial Distribution

  • 08717775956211 ()


  • Gastroduodenal motility analysis system

CIM AUX + C/HRM - 08717775956198

No Description
Medical Measurement Systems B.V.
CIM AUX + C/HRM
In Commercial Distribution

  • 08717775956198 ()


  • Gastroduodenal motility analysis system

CIM AUX + C/IMP - 08717775956181

No Description
Medical Measurement Systems B.V.
CIM AUX + C/IMP
In Commercial Distribution

  • 08717775956181 ()


  • Gastroduodenal motility analysis system

CIM AUX + C/HRM + C/IMP - 08717775956174

No Description
Medical Measurement Systems B.V.
CIM AUX + C/HRM + C/IMP
In Commercial Distribution

  • 08717775956174 ()


  • Gastroduodenal motility analysis system

S-Puller-BT-GI - 08717775956150

No Description
Medical Measurement Systems B.V.
S-Puller-BT-GI
In Commercial Distribution

  • 08717775956150 ()


  • Gastroduodenal motility analysis system

CIM AUX HRIM - 08717775955894

No Description
Medical Measurement Systems B.V.
CIM AUX HRIM
In Commercial Distribution

  • 08717775955894 ()


  • Gastroduodenal motility analysis system

CIM AUX - 08717775955887

No Description
Medical Measurement Systems B.V.
CIM AUX
In Commercial Distribution

  • 08717775955887 ()


  • Gastroduodenal motility analysis system

GI Trolly Gold - 08717775955795

No Description
Medical Measurement Systems B.V.
GI Trolly Gold
In Commercial Distribution

  • 08717775955795 ()


  • Gastroduodenal motility analysis system

GI Trolly Silver - 08717775955788

No Description
Medical Measurement Systems B.V.
GI Trolly Silver
In Commercial Distribution

  • 08717775955788 ()


  • Gastroduodenal motility analysis system

MPI - 08717775955757

No Description
Medical Measurement Systems B.V.
MPI
In Commercial Distribution

  • 08717775955757 ()


  • Gastroduodenal motility analysis system

MPP Plus - 08717775955733

No Description
Medical Measurement Systems B.V.
MPP Plus
In Commercial Distribution

  • 08717775955733 ()


  • Gastroduodenal motility analysis system

S-Puller GI - 08717775955726

No Description
Medical Measurement Systems B.V.
S-Puller GI
In Commercial Distribution

  • 08717775955726 ()


  • Gastroduodenal motility analysis system

Solar GI HRAM Solid State, Trolley system - 08717775955115

No Description
Medical Measurement Systems B.V.
G3-15
In Commercial Distribution

  • 08717775955115 ()


  • Gastroduodenal motility analysis system
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