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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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Visuscout 100 set
Optomed Oy
60100054A
In Commercial Distribution

  • 06430046260634 ()


  • Ophthalmic fundus camera
Thyroid Uptake System, Well Counter
BIODEX MEDICAL SYSTEMS, INC.
187-602
In Commercial Distribution

  • 00718175000137 ()
187-602

  • Thyroid-uptake nuclear medicine system
Thyroid Uptake System, AtomLab 960, 230 VAC
BIODEX MEDICAL SYSTEMS, INC.
187-601
In Commercial Distribution

  • 00718175000021 ()
187-601

  • Thyroid-uptake nuclear medicine system
Thyroid Uptake System, AtomLab 960, 120 VAC
BIODEX MEDICAL SYSTEMS, INC.
187-600
In Commercial Distribution

  • 00718175000014 ()
187-600

  • Thyroid-uptake nuclear medicine system
Ophthalmic Camera
OPTOVUE, INC.
Vivicon
In Commercial Distribution

  • 00858848006445 ()
700-53597-001

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

  • 00858848006414 ()
700-49517-004

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

  • 00858848006339 ()
700-49517-003

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

  • 00858848006322 ()
700-49517-002

  • Ophthalmic fundus camera
The Spect Ophthalmic Camera is a product consisting of an Apple iPhone, a mobile application (app), and an optical lens attachment and illumination source. The mobile app is accessible to users via the Apple App Store (Apple Inc.) for use on Spect issued iPhone devices. The Spect Ophthalmic Camera consists of a mechanical adaptor with a telescopic feature that houses a high-quality glass fundoscopic lens, and a white-light LED illumination source.
Spect Inc.
BOM001
In Commercial Distribution

  • 00853501008002 ()


  • Ophthalmic fundus camera
RetCam Envision without FA
XLTEK
61-000400
In Commercial Distribution

  • 00382830016896 ()


  • Ophthalmic fundus camera
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