Smart Medical Systems , Ltd. is one of 267 FDA 510(k) medical device manufacturers from Israel in the dataset, ranked by real submission volume.
Smart Medical Systems , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: G-EYE System, G-EYE System, G-EYE System
9
Total
9
Cleared
0
Denied
Smart Medical Systems , Ltd. has 9 FDA 510(k) cleared medical devices. Based in Kfar Saba, IL.
Last cleared in 2022. Active since 2006. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Smart Medical Systems , Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Hogan Lovells US LLP and Hogan Lovells US Lpp.
FDA 510(k) Regulatory Record - Smart Medical Systems , Ltd.
9 devices
Cleared
Apr 11, 2022
G-EYE System
Gastroenterology & Urology
82d
Cleared
Oct 26, 2020
G-EYE System
Gastroenterology & Urology
60d
Cleared
Apr 15, 2020
G-EYE System
Gastroenterology & Urology
209d
Cleared
Feb 06, 2012
NAVIAID ICVI-F,S,B,R DEVICE
Gastroenterology & Urology
199d
Cleared
Aug 09, 2011
NAVIAID(TM) BGC DEVICE
Gastroenterology & Urology
48d
Cleared
Jun 17, 2011
NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE
Gastroenterology & Urology
136d
Cleared
Dec 30, 2010
NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE
Gastroenterology & Urology
111d
Cleared
Jul 27, 2010
NAVIAID ICVI DEVICE
Gastroenterology & Urology
90d
Cleared
Aug 15, 2006
NAVIAID BGE DEVICE, MODEL 21-001
Gastroenterology & Urology
133d