Topcon Medical Systems, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Topcon Medical Systems, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Harmony
11
Total
11
Cleared
0
Denied
Topcon Medical Systems, Inc. has 11 FDA 510(k) cleared ophthalmic devices. Based in Paramus, US.
Historical record: 11 cleared submissions from 2003 to 2018.
Browse the complete list of FDA 510(k) cleared ophthalmic devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by O'Connell Regulatory Consultants, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Topcon Medical Systems, Inc.
11 devices
Cleared
Sep 28, 2018
Harmony
Ophthalmic
28d
Cleared
Oct 01, 2015
Synergy ODM
Ophthalmic
78d
Cleared
Oct 17, 2013
IMAGENET 5 PC SOFTWARE SYSTEM
Ophthalmic
73d
Cleared
Oct 09, 2013
SYNERGY ODM
Ophthalmic
43d
Cleared
Jun 05, 2013
TRC-50DX RETINAL CAMERA
Ophthalmic
244d
Cleared
Feb 06, 2013
TRC-NW300 NON-MYDRIATIC RETINAL CAMERA
Ophthalmic
89d
Cleared
May 23, 2011
SLIT LAMP SL-2G
Ophthalmic
90d
Cleared
Dec 02, 2009
SYNERGY
Radiology
41d
Cleared
Mar 13, 2009
3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM
Ophthalmic
123d
Cleared
Jan 13, 2009
TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF...
Ophthalmic
449d
Cleared
Dec 19, 2003
TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
Ophthalmic
189d