Nidek, Inc. - FDA 510(k) Cleared Devices
77
Total
77
Cleared
0
Denied
47 devices
Cleared
Feb 27, 1989
NIDEK AR-1200
Ophthalmic
21d
Cleared
Nov 23, 1988
NIDEK LM-870 AUTOMATIC LENSMETER
Ophthalmic
49d
Cleared
Sep 15, 1988
NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS)
Ophthalmic
48d
Cleared
Jul 01, 1988
NIDEK ARK-2000
Ophthalmic
38d
Cleared
May 25, 1988
NIDEK CV-4000
Ophthalmic
82d
Cleared
Oct 15, 1987
NIDEK ADC-8000 LASER SYSTEM
Ophthalmic
87d
Cleared
Jul 23, 1986
NIDEK KM-1000 SURGICAL KERATOMETER
Ophthalmic
49d
Cleared
Apr 15, 1986
LM-850 AUTOMATIC LENSMETER
Ophthalmic
26d
Cleared
Apr 09, 1986
AR-1100 AUTOMATIC REFRACTOR
Ophthalmic
20d
Cleared
Apr 04, 1986
AR-1600 AUTOMATIC REFRACTOR
Ophthalmic
15d
Cleared
Apr 04, 1986
NIDEK KM-800 AUTO KERATOMETER
Ophthalmic
15d
Cleared
Apr 04, 1986
AR-1000 AUTOMATIC REFRACTOR
Ophthalmic
15d
Cleared
Feb 07, 1986
NIDEK AC-2000 LASER SYSTEM
Ophthalmic
35d
Cleared
Feb 15, 1985
NIDEK-BINOCULAR INDIRECT OPHTHALMOSCOPE
Ophthalmic
156d
Cleared
Feb 15, 1985
NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE
Ophthalmic
156d
Cleared
Feb 15, 1985
MONOCULAR DIRECT OPHTHALMOSCOPE
Ophthalmic
53d
Cleared
Dec 24, 1984
ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS
Ophthalmic
55d
Cleared
Dec 24, 1984
ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE
Ophthalmic
55d
Cleared
Oct 05, 1984
NIDEK DIGITAL KERATOMETER
Ophthalmic
74d
Cleared
Mar 16, 1984
ARGON/KRYPTON ION LASER PHOTOCOAGULA
Ophthalmic
109d
Cleared
Jun 30, 1983
SUN PHOTO-KERATOSCOPE
Ophthalmic
87d
Cleared
Jun 10, 1983
AUTO REFRACTOMETER
Ophthalmic
67d