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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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iCam 12 MP
OPTOVUE, INC.
iCam100
In Commercial Distribution

  • 00858848006780 ()
700-54524-001

  • Ophthalmic fundus camera
iCam Camera Head 5 MP
OPTOVUE, INC.
iCam100
In Commercial Distribution

  • 00858848006278 ()
700-49517-001

  • Ophthalmic fundus camera
No Description
1BYONEPRODUCTS INC.
9-JK14US05
In Commercial Distribution

  • 00858069007191 ()
  • 00858069007184 ()
  • 10858069007198 ()


  • Telemetric sphygmomanometer
No Description
1BYONEPRODUCTS INC.
9-JK14US06
In Commercial Distribution

  • 00858069007177 ()
  • 00858069007153 ()
  • 10858069007174 ()


  • Telemetric sphygmomanometer
Wireless Arm Blood Pressure Monitor
1BYONEPRODUCTS INC.
TMB-1585-BT
In Commercial Distribution

  • 10858069007044 ()
  • 00858069007047 ()
  • 00858069007030 ()


  • Telemetric sphygmomanometer
Mydriatic Hyperspectral Retinal Camera (MHRC-C1N)
Optina Diagnostiques, Inc
MHRC-C1N
In Commercial Distribution

  • 00627987702132 ()


  • Ophthalmic fundus camera
Mydriatic Hyperspectral Retinal Camera (MHRC-C1)
Optina Diagnostiques, Inc
MHRC-C1
In Commercial Distribution

  • 00627987702125 ()


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

  • 04719872711162 ()


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

  • 04719872711155 ()


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

  • 04719872711148 ()


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

  • 04719872711131 ()


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

  • 04719872711124 ()


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

  • 04719872711117 ()


  • Ophthalmic fundus camera
Automated Portable Retinal Camera
CRYSTALVUE MEDICAL CORPORATION
VitaziView
In Commercial Distribution

  • 04719876420398 ()
700-C2701-431

  • Ophthalmic fundus camera
Automated Portable Retinal Camera
CRYSTALVUE MEDICAL CORPORATION
Halo
In Commercial Distribution

  • 04719876420275 ()
700-C2701-131

  • Ophthalmic fundus camera
Automated Portable Retinal Camera
CRYSTALVUE MEDICAL CORPORATION
NFC-600
In Commercial Distribution

  • 04719876420268 ()
700-C2701-031

  • Ophthalmic fundus camera
Non-Mydriatic Auto Fundus Camera
CRYSTALVUE MEDICAL CORPORATION
Polaris
In Commercial Distribution

  • 04719876420176 ()
700-C1101-431

  • Ophthalmic fundus camera
Non-Mydriatic Auto Fundus Camera
CRYSTALVUE MEDICAL CORPORATION
RetinaStation
In Commercial Distribution

  • 04719876420060 ()
700-C1101-231

  • Ophthalmic fundus camera
Non-Mydriatic Auto Fundus Camera
CRYSTALVUE MEDICAL CORPORATION
NFC-700
In Commercial Distribution

  • 04719876420053 ()
700-C1101-031

  • Ophthalmic fundus camera
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
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