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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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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

Eyer 2 Basic - 07908616100097

Eyer 2 Basic
PHELCOM TECHNOLOGIES SA
Eyer 2 Basic
In Commercial Distribution

  • 07908616100097 ()


  • Ophthalmic fundus camera

Eyer - 07908616100042

Eyer Retinal Camera M-STD
PHELCOM TECHNOLOGIES SA
Eyer M-STD
In Commercial Distribution

  • 07908616100042 ()
M-STD

  • Ophthalmic fundus camera

Eyer - 07908616100011

Eyer Retinal Camera NM-STD
PHELCOM TECHNOLOGIES SA
Eyer NM-STD
In Commercial Distribution

  • 07908616100011 ()
NM-STD

  • Ophthalmic fundus camera

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

CM04 - 07640132987690

No Description
Haag-Streit AG
30/70 IM910
In Commercial Distribution

  • 07640132987690 ()
1023835

  • Ophthalmic fundus camera

CM04 - 07640132987669

No Description
Haag-Streit AG
IM 910
In Commercial Distribution

  • 07640132987669 ()
1023138

  • Ophthalmic fundus camera

Bowman Perfusion Monitor, 240V - B238H000107110

Perfusion Monitor, 240V
HEMEDEX, INC
Model 500
In Commercial Distribution

  • B238H000107110 ()
H0001-0711

  • Patient monitoring system module, intracranial pressure
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