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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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HANDLE & CHARGER F/HORUS SCOPE
JEDMED INSTRUMENT COMPANY
39-7420
In Commercial Distribution

  • M6333974200 ()
39-7420

  • Ophthalmic fundus camera
BATTERY F/HORUS +DIGITAL OTOSCOPE
JEDMED INSTRUMENT COMPANY
39-7408
In Commercial Distribution

  • M6333974080 ()
39-7408

  • Ophthalmic fundus camera
HORUS + DIGITAL OTOSCOPE
JEDMED INSTRUMENT COMPANY
39-7405
In Commercial Distribution

  • M6333974050 ()
39-7405

  • Ophthalmic fundus camera
The CenterVue DRSplus is a confocal scanning ophthalmoscope indicated for color imaging of a human retina without the use of a mydriatic agent.
CENTERVUE SPA
DRSplus
In Commercial Distribution

  • 08053677040116 ()


  • Ophthalmic fundus camera
FUNDUS CAMERA
CENTERVUE SPA
DRS
In Commercial Distribution

  • 08053677040017 ()


  • Ophthalmic fundus camera
HFC-1 fundus camera is intended to capture digital images for the anterior and retina segment of the eye without the use of a mydriatic agent. It is intended for use as an aid to clinicians in the evaluation and diagnosis of ocular health.
Huvitz Co., Ltd.
HFC-1
In Commercial Distribution

  • 08800019600541 ()
HFC-1

  • Ophthalmic fundus camera
No Description
ILOODA.CO.,LTD
RetiCapture
In Commercial Distribution

  • 08800023201017 ()


  • Ophthalmic fundus camera
Automatic eye-fundus camera and software intended for photographing, displaying,and storing images of the retina without the use of a mydriatic agent.
LUNEAU TECHNOLOGY OPERATIONS
Retina 800
In Commercial Distribution

  • 03664188000435 ()
RET1IN

  • Ophthalmic fundus camera
No Description
LUNEAU TECHNOLOGY OPERATIONS
Velara 200
In Commercial Distribution

  • 03664188000428 ()


  • Ophthalmic fundus camera
No Description
LUNEAU TECHNOLOGY OPERATIONS
VX610
In Commercial Distribution

  • 03664188000411 ()


  • Ophthalmic fundus camera
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