Nidek, Inc. - FDA 510(k) Cleared Devices
77
Total
77
Cleared
0
Denied
47 devices
Cleared
Aug 24, 2005
OPD-STATION SOFTWARE
Ophthalmic
195d
Cleared
Dec 04, 2003
NON-CONTACT TONOMETER, MODEL NT-4000
Ophthalmic
183d
Cleared
Nov 19, 2002
NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)
Ophthalmic
377d
Cleared
Apr 17, 2002
NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000
Ophthalmic
111d
Cleared
Feb 11, 2002
DC-3300 LASER DIODE PHOTOCOAGULATOR
Ophthalmic
90d
Cleared
Sep 24, 1999
MICROKERATOME, MODEL MK-2000
Ophthalmic
190d
Cleared
Aug 06, 1999
ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM
Ophthalmic
113d
Cleared
Nov 04, 1997
NIDEK HANDY
Ophthalmic
69d
Cleared
Nov 04, 1997
NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)
Ophthalmic
47d
Cleared
Nov 05, 1996
HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM
Ophthalmic
288d
Cleared
Sep 14, 1995
NIDEK MODEL GYC-1500 AND GYC-2000
Ophthalmic
189d
Cleared
Jul 19, 1995
STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION)
Ophthalmic
90d
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