Topcon Corp. is one of 18943 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Topcon Corp. - FDA 510(k) Cleared Devices
Recent clearances: TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA, SLIT LAMP SL-D701, TRC-NW8 NON-MYDRIATIC RETINAL CAMERA
9
Total
9
Cleared
0
Denied
Topcon Corp. has 9 FDA 510(k) cleared medical devices. Based in Paramus, US.
Historical record: 9 cleared submissions from 2004 to 2014. Primary specialty: Ophthalmic.
Browse the FDA 510(k) cleared devices submitted by Topcon Corp. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Tuv Rheinland of North America, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Topcon Corp.
9 devices
Cleared
Oct 23, 2014
TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA
Ophthalmic
156d
Cleared
Aug 26, 2014
SLIT LAMP SL-D701
Ophthalmic
270d
Cleared
May 10, 2013
TRC-NW8 NON-MYDRIATIC RETINAL CAMERA
Ophthalmic
94d
Cleared
Feb 12, 2010
NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F
Ophthalmic
18d
Cleared
Sep 02, 2009
OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000
Ophthalmic
21d
Cleared
Jun 30, 2009
RETINA CAMERA TRC-NW7SF MARK II
Ophthalmic
160d
Cleared
Sep 30, 2008
IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR...
Ophthalmic
43d
Cleared
Jun 22, 2007
TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM
Ophthalmic
226d
Cleared
Nov 05, 2004
TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA
Ophthalmic
165d