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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
VOLK OPTICAL INC.
VP2ANTK
In Commercial Distribution

  • 00811608018621 ()


  • Ophthalmic fundus camera
No Description
VOLK OPTICAL INC.
VP2RETK
In Commercial Distribution

  • 00811608018614 ()


  • Ophthalmic fundus camera
No Description
VOLK OPTICAL INC.
VP2ANT
In Commercial Distribution

  • 00811608018577 ()


  • Ophthalmic fundus camera
No Description
VOLK OPTICAL INC.
VP2RET
In Commercial Distribution

  • 00811608018560 ()


  • Ophthalmic fundus camera
No Description
VOLK OPTICAL INC.
VP1COMPK
In Commercial Distribution

  • 00811608018065 ()


  • Ophthalmic fundus camera
No Description
VOLK OPTICAL INC.
VP1OPHK
In Commercial Distribution

  • 00811608018003 ()


  • Ophthalmic fundus camera
No Description
VOLK OPTICAL INC.
VP1RETK
In Commercial Distribution

  • 00811608017969 ()


  • Ophthalmic fundus camera
No Description
VOLK OPTICAL INC.
VP1ANT
In Commercial Distribution

  • 00811608017822 ()


  • Ophthalmic fundus camera
No Description
VOLK OPTICAL INC.
VP1RET
In Commercial Distribution

  • 00811608017815 ()


  • Ophthalmic fundus camera
No Description
VOLK OPTICAL INC.
VP1HAND
In Commercial Distribution

  • 00811608017808 ()


  • Ophthalmic fundus camera
No Description
VOLK OPTICAL INC.
VPPFUNDUSK
In Commercial Distribution

  • 00811608012261 ()


  • Ophthalmic fundus camera
No Description
VOLK OPTICAL INC.
VPPFULLK
In Commercial Distribution

  • 00811608012254 ()


  • Ophthalmic fundus camera
No Description
VOLK OPTICAL INC.
VVISTAVIEW
In Commercial Distribution

  • 00811608011783 ()


  • Ophthalmic fundus camera
Perfusion Monitor, 240V
HEMEDEX, INC
Model 500
In Commercial Distribution

  • B238H000107110 ()
H0001-0711

  • Patient monitoring system module, intracranial pressure
Thermal Diffusion Probe
HEMEDEX, INC
NA
In Commercial Distribution

  • B238H000016000 ()
H0000-1600

  • Patient monitoring system module, intracranial pressure
Perfusion Monitor, 120V
HEMEDEX, INC
Model 500
In Commercial Distribution

  • B238H000007100 ()
H0000-0710

  • Patient monitoring system module, intracranial pressure
Tenovi Cellular Blood Pressure Monitor
Tenovi Co.
TC-CBP-01
In Commercial Distribution

  • G004TCCBP010 ()


  • Telemetric sphygmomanometer
Tenovi Bluetooth Blood Pressure Monitor - Small Cuff Size
Tenovi Co.
TC-BPM-S2
In Commercial Distribution

  • G004TCBPMS20 ()


  • Telemetric sphygmomanometer
Tenovi Bluetooth Blood Pressure Monitor - Large Cuff Size
Tenovi Co.
TC-BPM-L2
In Commercial Distribution

  • G004TCBPML20 ()


  • Telemetric sphygmomanometer
Bluetooth Blood Pressure Monitor
Tenovi Co.
TC-BPM-A2
In Commercial Distribution

  • G004TCBPMA20 ()


  • Telemetric sphygmomanometer
Bluetooth Blood Pressure Monitor
Tenovi Co.
TC-BPM-A1
In Commercial Distribution

  • G004TCBPMA10 ()


  • 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
The device WRI-1 is an ophthalmic imaging device and intended to be used by health care professionals to capture, display, and store color and monochrome images of the retina without contact to the patient eye.
Cellview Imaging Inc.
01
In Commercial Distribution

  • 00628678036017 ()


  • Ophthalmic fundus camera
KOWA nonmyd AF is intended for use with retinal image capturing without requiring the patients to take any mydriatic.
KOWA COMPANY,LTD.
K9L64K
In Commercial Distribution

  • 04987646809128 ()


  • Ophthalmic fundus camera
The KOWA DR-1α is an ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by physician in adult patients to observe and record a video image of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.
KOWA COMPANY,LTD.
DE2K
Not in Commercial Distribution

  • 04987646807728 ()


  • Ophthalmic fundus camera
The KOWA nonmyd 8s is intended for use with retinal image capturing without mydriatic.
KOWA COMPANY,LTD.
K9L63K
In Commercial Distribution

  • 04987646807612 ()

  • Height: 548 Millimeter
  • Depth: 504 Millimeter
  • Width: 310 Millimeter
  • Weight: 21 Kilogram


  • Ophthalmic fundus camera
The KOWA nonmyd 8 is intended for use with retinal image capturing without mydriatic.
KOWA COMPANY,LTD.
K9L61K
In Commercial Distribution

  • 04987646807575 ()

  • Width: 310 Millimeter
  • Depth: 504 Millimeter
  • Height: 548 Millimeter
  • Weight: 21 Kilogram


  • Ophthalmic fundus camera
KOWA nonmyd 7 is intended for use with retina image capturing without mydriatic. The retina image can be stored to an image filing equipment through serial interface.
KOWA COMPANY,LTD.
K9L39F9K
In Commercial Distribution

  • 04987646807360 ()

  • Depth: 504 Millimeter
  • Height: 548 Millimeter
  • Width: 310 Millimeter
  • Weight: 21 Kilogram


  • Ophthalmic fundus camera
KOWA nonmyd WX is intended for use with plane and stereo retinal image capturing without mydriatic. The retina image can be stored to an image filing derive through serial interface.
KOWA COMPANY,LTD.
K9L57FK
In Commercial Distribution

  • 04987646806592 ()

  • Height: 548 Millimeter
  • Depth: 504 Millimeter
  • Width: 310 Millimeter
  • Weight: 21 Kilogram


  • Ophthalmic fundus camera
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