NIDEK CO.,LTD.

Address:34-14 MAEHAMA, HIROISHI-CHO,GAMAGORI, AICHI,JP

Want to know more about this Organization? Request more information now!

Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Laser, Ophthalmic (HQF) (3) Powered Laser Surgical Instrument (GEX) (2) Speculum, Illuminated (FXF) (2) Camera, Ophthalmic, Ac-Powered (HKI) (1) Otoscope (ERA) (1) Loupe, Diagnostic/Surgical (FSP) (1) Camera, Ophthalmic, General-Use (PJZ) (1) Camera, Still, Surgical (FTT) (1)

Premarket Exempt

No Yes

Clear

Expansion box - 04987669100967 Catalog Number :

Device Description : Expansion box is the optional accessory that is used to connect a scan delivery Expansion box is the optional accessory that is used to connect a scan delivery unit and the external devices (LAN cable, barcode scanner, or magnetic card reader) to the GYC-500.

Device Class : 2

Duns Number: 690635461

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

Endophotocoagulation Delivery Unit - 04987669100974 Catalog Number :

Device Description : The delivery unit is used for endophotocoagulation. The photocoagulation system The delivery unit is used for endophotocoagulation. The photocoagulation system can be easily comprised by connecting the optional sterilized endophotoprobe or optional sterilized coaxial illumination probe to the Green Laser Photocoagulator GYC-1000 and GYC-500, and attaching the protective filter to the main laser device as well as the surgical microscope. This photocoagulation system enables laser endophotocoagulation while observing the affected area through the surgical microscope.

Device Class : 2

Duns Number: 690635461

Premarket Exempt : No

Product Code : GEX, HQF

Prescription Use : Yes

Device Count : 1

Endophotocoagulation Delivery Unit - 04987669100981 Catalog Number :

Device Description : The delivery unit is used for endophotocoagulation. The photocoagulation system The delivery unit is used for endophotocoagulation. The photocoagulation system can be easily comprised by connecting the optional sterilized endophotoprobe or optional sterilized coaxial illumination probe to the Multicolor Laser Photocoagulator System MC-500, and attaching the protective filter to the main laser device as well as the surgical microscope. This photocoagulation system enables laser endophotocoagulation while observing the affected area through the surgical microscope.

Device Class : 2

Duns Number: 690635461

Premarket Exempt : No

Product Code : GEX, HQF

Prescription Use : Yes

Device Count : 1

DIGITAL MEDICAL SCOPE - 04987669100998 Catalog Number :

Device Description : NIDEK DS-10F is a digital hand-held eye-fundus camera used to record digital pho NIDEK DS-10F is a digital hand-held eye-fundus camera used to record digital photographs and video of fundus (including retina, macula and optic disc) of the human eye and surrounding area.

Device Class : 2

Duns Number: 690635461

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

DIGITAL MEDICAL SCOPE - 04987669101001 Catalog Number :

Device Description : NIDEK DS-20 is a digital hand-held eye-fundus camera used to record digital phot NIDEK DS-20 is a digital hand-held eye-fundus camera used to record digital photographs and video of fundus (including retina, macula and optic disc) of the human eye and surrounding area.

Device Class : 2

Duns Number: 690635461

Premarket Exempt : Yes

Product Code : PJZ

Prescription Use : Yes

Device Count : 1

DIGITAL MEDICAL SCOPE - 04987669101018 Catalog Number :

Device Description : DS-10A is a digital hand-held anterior scope used to record digital photographs DS-10A is a digital hand-held anterior scope used to record digital photographs and video of anterior area of the human eye and surrounding area.

Device Class : 1

Duns Number: 690635461

Premarket Exempt : Yes

Product Code : FXF

Prescription Use : Yes

Device Count : 1

DIGITAL MEDICAL SCOPE - 04987669101025 Catalog Number :

Device Description : DS-10D is a digital hand-held dermatoscope used to record digital photographs an DS-10D is a digital hand-held dermatoscope used to record digital photographs and video of the human skin.

Device Class : 1

Duns Number: 690635461

Premarket Exempt : Yes

Product Code : FSP

Prescription Use : Yes

Device Count : 1

DIGITAL MEDICAL SCOPE - 04987669101032 Catalog Number :

Device Description : DS-10E is a digital hand-held otoscope used to record digital photographs and vi DS-10E is a digital hand-held otoscope used to record digital photographs and video of the human ear’s canal and tympanic membrane.

Device Class : 1

Duns Number: 690635461

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : Yes

Device Count : 1

DIGITAL MEDICAL SCOPE - 04987669101049 Catalog Number :

Device Description : DS-10G is a digital hand-held camera used to record digital photographs and vide DS-10G is a digital hand-held camera used to record digital photographs and video of the human body.

Device Class : 1

Duns Number: 690635461

Premarket Exempt : Yes

Product Code : FXF

Prescription Use : Yes

Device Count : 1

DIGITAL MEDICAL SCOPE - 04987669101056 Catalog Number :

Device Description : DS-10EA Adapter is designed to connect the control unit of DS-10 and the existin DS-10EA Adapter is designed to connect the control unit of DS-10 and the existing endoscope in the market. The assembly system (control unit & DS-10EA Adapter & existing endoscope in the market) can be used to record digital photographs and video of the body.

Device Class : 1

Duns Number: 690635461

Premarket Exempt : Yes

Product Code : FTT

Prescription Use : Yes

Device Count : 1

Previous 1 … 7 8 9 … 12 Next