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NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images.
FDA Recall
Terminated
·Nidek, Inc.·Product code NQE·February 25, 2019
SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses.
FDA Recall
Terminated
·Nidek Inc·Product code NQE·August 8, 2016
Microscope, Specular
FDA classification
FDA Class 2
·Microscope, Specular
Biomerics NLE
FDA registration
Biomerics NLE·1 product·🇺🇸 United States
NSE-AUTOMATECH
FDA registration
NSE-AUTOMATECH·6 products·🇨🇦 Canada
NSE PRODUCTS, INC.
FDA registration
NSE PRODUCTS, INC.·3 products·🇺🇸 United States
SHENZHEN NOE OPTICAL CO., LTD
FDA registration
SHENZHEN NOE OPTICAL CO., LTD·2 products·🇨🇳 China
NA
FDA UDI
Fehling Instruments GmbH & Co. KG·04058749103861·Xiphoid and distal IMA-blade 40x60x20mm for MQC-1
NA
FDA UDI
Fehling Instruments GmbH & Co. KG·04058749103878·Xiphoid and distal IMA-blade 40x45x20mm for MQC-1
NA
FDA UDI
Fehling Instruments GmbH & Co. KG·04058749103885·Xiphoid and distal IMA-blade 40x30x20mm for MQC-1
Mast Assure Antisera
FDA UDI
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FDA UDI
ALIFAX SRL·08056040145425·
LATEX EQE (2 TEST)
FDA UDI
ALIFAX SRL·08056040145401·
LATEX EQE (2 TEST)
FDA UDI
ALIFAX SRL·08056040145395·
NCE REPLACEMENT BATTERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
NCE REPLACEMENT BATTERIES
FDA 510(k)
FDA Class 2
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NCE REPLACEMENT BATTERIES
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
n!ce for Planmill
FDA 510(k)
FDA Class 2
·Dental
Community Hospice of N.E. Florida
FDA UDI
Drive Devilbiss Healthcare·00822383511900·Comm-Hospice, PowerNeb Ultra, 1/ea
800 P37,JE,N,BE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828186988·800 P37,JE,N,BE