Nidek, Inc. - FDA 510(k) Cleared Devices
77
Total
77
Cleared
0
Denied
77 devices
Cleared
Jul 19, 1995
STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION)
Ophthalmic
90d
Cleared
Jul 15, 1994
NIDEK MODEL VT-4000, MODIFICATION
Ophthalmic
198d
Cleared
Nov 22, 1993
NIDEK MODEL AC-2300
Ophthalmic
164d
Cleared
Mar 29, 1993
NIDEK MODEL VST-4000
Ophthalmic
213d
Cleared
Mar 26, 1993
NIDEK CV-12000
Ophthalmic
214d
Cleared
Dec 24, 1991
DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE
Ophthalmic
210d
Cleared
Oct 21, 1991
NIDEK MODELS AC-2100 & 2200
General & Plastic Surgery
77d
Cleared
Oct 15, 1991
NIDEK MODEL NT-1000
Ophthalmic
89d
Cleared
Feb 04, 1991
NIDEK DC-3000 DIODE LASER PHOTOCOAGULATOR
General & Plastic Surgery
175d
Cleared
Dec 07, 1990
NIDEK INC. MODEL AC-2000 DERM
General & Plastic Surgery
73d
Cleared
Nov 21, 1990
NIDEK US-2000
Radiology
119d
Cleared
Oct 09, 1990
NIDEK US-2500 W/BIOMETRY UNIT US-2520
Radiology
131d
Cleared
Sep 10, 1990
NIDEK MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA
General & Plastic Surgery
195d
Cleared
Sep 10, 1990
NIDEK, INC. MODEL ADC-8000 DERM
General & Plastic Surgery
195d
Cleared
Jul 27, 1990
AR-1600G AUTO-REFRACTOMETER
Ophthalmic
52d
Cleared
Jun 20, 1990
MODEL YC-1200/PHOTOCOAGULATOR OPHTHALMIC LASER
General & Plastic Surgery
83d
Cleared
Jun 08, 1990
NIDEK RT-1200S (MARCO TRS-1200)
Ophthalmic
70d
Cleared
Jun 08, 1990
NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000
Ophthalmic
57d
Cleared
Mar 27, 1990
NIDEK, INC. MODELS YC-1100 OPHTHALMIC LASERS
General & Plastic Surgery
74d
Cleared
Mar 22, 1990
NIDEK, INC. BIO-DC LASER DELIVERY SYSTEM
General & Plastic Surgery
69d
Cleared
Oct 16, 1989
MODEL DC-1200 DIODE LASER PHOTOCOAGULATOR
Ophthalmic
66d
Cleared
Oct 04, 1989
NIDEK MODEL ADC-8000
General & Plastic Surgery
72d
Cleared
Aug 18, 1989
NIDEK MODEL YC-1200
Ophthalmic
74d
Cleared
Aug 07, 1989
NIDEK MODEL AKC-8000
Ophthalmic
46d
Cleared
Jun 22, 1989
NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS
Ophthalmic
80d
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