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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Perfusion Monitor, 120V
HEMEDEX, INC
Model 500
In Commercial Distribution

  • B238H000007100 ()
H0000-0710

  • Patient monitoring system module, intracranial pressure
ICON GO & FA
NEOLIGHT LLC
PCI 40-2100FA
In Commercial Distribution

  • 20852788008051 ()


  • Ophthalmic fundus camera
ICON GO
NEOLIGHT LLC
PCI 40-2100
In Commercial Distribution

  • 20852788008044 ()


  • Ophthalmic fundus camera
ICON Cart
NEOLIGHT LLC
PCI 40-1100
In Commercial Distribution

  • 20852788008037 ()


  • Ophthalmic fundus camera
ICON Cart & FA
NEOLIGHT LLC
PCI 40-1100FA
In Commercial Distribution

  • 20852788008020 ()


  • Ophthalmic fundus camera
No Description
Changsha Airdoc Health Technology Co., Ltd.
AI-FD16aN
In Commercial Distribution

  • 06976107790301 ()


  • Ophthalmic fundus camera
It is an AC-powered device intended to take photographs of the fundus of eye
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
SK-660A
In Commercial Distribution

  • 06973211070626 ()


  • Ophthalmic fundus camera
It is an AC-powered device intended to take photographs of the fundus of eye
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
SK-650A
In Commercial Distribution

  • 06973211070602 ()


  • Ophthalmic fundus camera
This equipment adopts advanced opto-mechanical and electrical integration technology, and integrates fundus digital image acquisition and image processing system. It can display color fundus images continuously, real-time and high-quality.The fundus digital image acquisition and image processing system processes the static images of the fundus color images with full digital processing, completes real-time recording and storage, and can be used for image processing, inspection reports, graphic editing, and data retrieval management for medical record generation at any time. The size of the lesion can be measured and calculated, the image can be scaled, moved, and pasted, and the color of the image can be adjusted. The image data of the case can be exported to the U disk and attached to the patient's case, which can assist scientific research and teaching
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
SK-680A
In Commercial Distribution

  • 06973211070008 ()


  • Ophthalmic fundus camera
No Description
Chongqing Bio NewVision Medical Equipment Ltd.
RetiCam 3100
In Commercial Distribution

  • 06973009600011 ()


  • Ophthalmic fundus camera
No Description
Suzhou Microclear Medical Instruments Co., Ltd.
FC-03
In Commercial Distribution

  • 06970990160067 ()


  • Ophthalmic fundus camera
No Description
Suzhou Microclear Medical Instruments Co., Ltd.
FC-02
In Commercial Distribution

  • 06970990160050 ()


  • Ophthalmic fundus camera
No Description
Suzhou Microclear Medical Instruments Co., Ltd.
FC-01
In Commercial Distribution

  • 06970990160043 ()


  • Ophthalmic fundus camera
No Description
Suzhou Microclear Medical Instruments Co., Ltd.
HFC
In Commercial Distribution

  • 06970990160012 ()


  • Ophthalmic fundus camera
This system adopts the most advanced Optical-electro-mechanical Integration technology. It integrates digital Fundus-Fluorescein-Angiography camera and digital-fundus-images acquisition and processing system, which can continuously display real-time, high quality color fundus images as well as black-white Fundus-Fluorescein-Angiography video images. The fundus images acquisition and processing system can process (full digital), record (real-time and completely) and save the color fundus images as well as retinal-fluorescein-angiography dynamic & static images into the computer. You can modify pictures, check reports, edit Graph-texts and manage all the dates at any time you want; you can measure and calculate the size of the case focus; you can zoom, move, stick, and put together the pictures; you can adjust the color on the picture, you can also record all the data on the CD, which can assistant scientific research and teaching. This system has combine function of many fundus image acquisition instruments, which can support medical treatments.
Chongqing Kanghuaruiming S&T Co., Ltd..
APS-DER
In Commercial Distribution

  • 06951214400220 ()


  • Ophthalmic fundus camera
This system adopts the most advanced Optical-electro-mechanical Integration technology. It integrates digital Fundus-Fluorescein-Angiography camera and digital-fundus-images acquisition and processing system, which can continuously display real-time, high quality color fundus images as well as black-white Fundus-Fluorescein-Angiography video images. The fundus images acquisition and processing system can process (full digital), record (real-time and completely) and save the color fundus images as well as retinal-fluorescein-angiography dynamic & static images into the computer. You can modify pictures, check reports, edit Graph-texts and manage all the dates at any time you want; you can measure and calculate the size of the case focus; you can zoom, move, stick, and put together the pictures; you can adjust the color on the picture, you can also record all the data on the CD, which can assistant scientific research and teaching. This system has combine function of many fundus image acquisition instruments, which can support medical treatments.
Chongqing Kanghuaruiming S&T Co., Ltd..
APS-CER
In Commercial Distribution

  • 06951214400213 ()


  • Ophthalmic fundus camera
This system adopts the most advanced Optical-electro-mechanical Integration technology. It integrates digital Fundus-Fluorescein-Angiography camera and digital-fundus-images acquisition and processing system, which can continuously display real-time, high quality color fundus images as well as black-white Fundus-Fluorescein-Angiography video images. The fundus images acquisition and processing system can process (full digital), record (real-time and completely) and save the color fundus images as well as retinal-fluorescein-angiography dynamic & static images into the computer. You can modify pictures, check reports, edit Graph-texts and manage all the dates at any time you want; you can measure and calculate the size of the case focus; you can zoom, move, stick, and put together the pictures; you can adjust the color on the picture, you can also record all the data on the CD, which can assistant scientific research and teaching. This system has combine function of many fundus image acquisition instruments, which can support medical treatments.
Chongqing Kanghuaruiming S&T Co., Ltd..
APS-BER
In Commercial Distribution

  • 06951214400084 ()


  • Ophthalmic fundus camera
This device is used to create digital colour photographic images of the ocular fundus through the pupil, to aid in diagnosing and monitoring retinal pathology.
Chongqing Kanghuaruiming S&T Co., Ltd..
APS-AER
In Commercial Distribution

  • 06951214400077 ()


  • Ophthalmic fundus camera
The KOWA VX-20 is intended for taking pictures of retinal images with mydriatic or without mydriatic.
KOWA COMPANY,LTD.
K9L56BK
In Commercial Distribution

  • 04987646807278 ()

  • Height: 720 Millimeter
  • Depth: 540 Millimeter
  • Width: 390 Millimeter
  • Weight: 39 Kilogram


  • Ophthalmic fundus camera
The Nidek Mirante Scanning Laser Ophthalmoscope is an ophthalmic imaging device that allows non invasive and non-contact observation of the shape and the disease state of the fundus, anterior segment, and retina using a scanning laser ophthalmoscope (hereafter referred to as “SLO”) and/or optical coherence tomography (hereafter referred to as “OCT”).
NIDEK CO.,LTD.
Mirante
In Commercial Distribution

  • 04987669101568 ()


  • Scanning-laser retinal imaging system
  • Retinal optical coherence tomography system
Voicepro NOAH is fitting software with a NOAH Database used in conjunction with Persona Medical hearing instruments as a tool by Audiologists/Hearing Instrument Specialists to mitigate hearing loss. The Noah software system is designed specifically for the hearing care industry, providing hearing care professionals with a unified system for performing client-related tasks.
Persona Medical
Voicepro Fitting Software NOAH
In Commercial Distribution

  • 00851362008049 ()


  • Hearing aid wireless-fitting computer-aided set
  • Air-conduction hearing aid, behind-the-ear
Voicepro is fitting software used in conjunction with Persona Medical hearing instruments as a tool by Audiologists/Hearing Instrument Specialists to mitigate hearing loss.
Persona Medical
Voicepro Fitting Software
In Commercial Distribution

  • 00851362008032 ()


  • Hearing aid wireless-fitting computer-aided set
  • Air-conduction hearing aid, behind-the-ear
No Description
Heidelberg Engineering GmbH
Software V.7.2-US with Heidelberg Eye Explorer
In Commercial Distribution

  • 04059237001034 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
Software V.7.2-US
In Commercial Distribution

  • 04059237001027 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
S2002
In Commercial Distribution

  • 04059237000891 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
S1002
In Commercial Distribution

  • 04059237000884 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
Software with HEYEX 2 V7.0-US
In Commercial Distribution

  • 04059237000839 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
Software V7.0-US
In Commercial Distribution

  • 04059237000815 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
S3610 [SN>20000]
In Commercial Distribution

  • 04059237000723 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
Software 6.12_US
In Commercial Distribution

  • 04059237000570 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
Software V6.10-US
In Commercial Distribution

  • 04059237000525 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
SP-PWS-1001A
In Commercial Distribution

  • 04059237000501 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
Software 6.13_US
In Commercial Distribution

  • 04059237000464 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
Product Famliy with HEYEX 2 SW V6.9b-US
In Commercial Distribution

  • 04059237000358 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
SPEC-CAM-S2610
In Commercial Distribution

  • 04059237000297 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
Image Capture Module SW V1.2
In Commercial Distribution

  • 04059237000259 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
Flex Module
Heidelberg Engineering GmbH
86549
In Commercial Distribution

  • 04059237000235 ()
86549

  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
HMO
In Commercial Distribution

  • 04059237000211 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
UWF1
In Commercial Distribution

  • 04059237000150 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
WFO2
In Commercial Distribution

  • 04059237000136 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
VAO
In Commercial Distribution

  • 04059237000112 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
Product Family SW V6.6
In Commercial Distribution

  • 04059237000105 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
SPEC-CAM-S3610
In Commercial Distribution

  • 04059237000099 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
SPEC-CAM-S1610
In Commercial Distribution

  • 04059237000082 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
SPEC-TSP
In Commercial Distribution

  • 04059237000075 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
SP-PWS-2001A
In Commercial Distribution

  • 04059237000068 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
SP-PWS-2000A
In Commercial Distribution

  • 04059237000051 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
SP-PWS-1000A
In Commercial Distribution

  • 04059237000044 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
SPEC-CAM-S3600
In Commercial Distribution

  • 04059237000037 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
SPEC-CAM-S2000
In Commercial Distribution

  • 04059237000020 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
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