354 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NIDEK MEDICAL PRODUCTS, INC.
FDA registration
NIDEK MEDICAL PRODUCTS, INC.·4 products·🇺🇸 United States
NIDEK INC. MODEL AC-2000 DERM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NIDEK, INC. MODEL ADC-8000 DERM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NIDEK, INC. BIO-DC LASER DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NIDEK, INC. MODELS YC-1100 OPHTHALMIC LASERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS
FDA 510(k)
FDA Class 2
·Ophthalmic
YC-1800
FDA Adverse Event
Injury
·NIDEK INC.·Product code LXS·June 29, 2020
NIDEK YAG LASER YC-1300
FDA Adverse Event
Injury
·NIDEK CO., LTD.·Product code LZS·October 11, 2013
YC-200 S PLUS
FDA Adverse Event
Malfunction
·NIDEK CO. LTD.·Product code HQF·May 20, 2022
EC-5000 QUEST
FDA Adverse Event
NIDEK CO., LTD.·Product code HQF·April 28, 2016
YC-1800
FDA Adverse Event
Malfunction
·NIDEK CO., LTD·Product code LXS·April 10, 2018
NIDEK MK-2000, KERATOME
FDA Adverse Event
Injury
·NIDEK CO. LTD.·Product code HNO·July 11, 2008
NIDEK EC-500 EXCIMER LASER SYSTEM
FDA Adverse Event
Injury
·NIDEK CO., LTD.·Product code LZS·October 11, 2013
NIDEK EC-5000 EXCIMER LASER SYSTEM
FDA Adverse Event
Injury
·NIDEK CO., LTD.·Product code LZS·October 11, 2013
NIDEK EC-5000 EXCIMER LASER SYSTEM
FDA Adverse Event
Injury
·NIDEK CO., LTD.·Product code LZS·October 11, 2013
YC-1800
FDA Adverse Event
Malfunction
·NIDEK CO., LTD·Product code LXS·April 27, 2018
AL-SCAN
FDA Adverse Event
Malfunction
·NIDEK CO. LTD.·Product code HJO·October 29, 2018
YC-200 S PLUS
FDA Adverse Event
Malfunction
·NIDEK CO. LTD.·Product code HQF·May 20, 2022
NIDEK EC-5000 EXCIMER LASER SYSTEM
FDA Adverse Event
Injury
·NIDEK CO. LTD·Product code LZS·May 10, 2010
YC-1800
FDA Adverse Event
Malfunction
·NIDEK CO., LTD·Product code LXS·April 10, 2018