Nidek Technologies Srl is one of 19692 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Nidek Technologies Srl - FDA 510(k) Cleared Devices
Recent clearances: NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX, ORION, MP-1 MICROPERIMETER
5
Total
5
Cleared
0
Denied
Nidek Technologies Srl has 5 FDA 510(k) cleared medical devices. Based in Lake Forest, US.
Historical record: 5 cleared submissions from 2001 to 2012. Primary specialty: Ophthalmic.
Browse the FDA 510(k) cleared devices submitted by Nidek Technologies Srl Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Tuv America, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Nidek Technologies Srl
5 devices
Cleared
May 08, 2012
NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX
Ophthalmic
169d
Cleared
Apr 24, 2007
ORION
Ophthalmic
90d
Cleared
Sep 28, 2006
MP-1 MICROPERIMETER
Ophthalmic
97d
Cleared
Dec 23, 2002
MP-1 MICRO PERIMETER
Ophthalmic
48d
Cleared
Oct 26, 2001
CONFOSCAN 2 CONFOCAL MICROSCOPE
Ophthalmic
88d