Elekta Instrument AB is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Elekta Instrument AB - FDA 510(k) Cleared Devices
Recent clearances: Leksell Vantage Stereotactic System, Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell GammaPlan
35
Total
35
Cleared
0
Denied
Elekta Instrument AB has 35 FDA 510(k) cleared medical devices. Based in Lake Forest, US.
Historical record: 35 cleared submissions from 1996 to 2019. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Elekta Instrument AB Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Elekta Instrument AB
35 devices
Cleared
Aug 01, 2019
Leksell Vantage Stereotactic System
Neurology
119d
Cleared
Mar 30, 2018
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon
Radiology
106d
Cleared
Feb 09, 2018
Leksell GammaPlan
Radiology
57d
Cleared
Sep 15, 2017
Leksell Vantage Stereotactic System
Neurology
151d
Cleared
Apr 20, 2016
Leksell Gamma Knife Icon
Radiology
63d
Cleared
Mar 02, 2016
Leksell Stereotactic System, Injection/ Aspiration Needle Kit
Neurology
175d
Cleared
Oct 29, 2015
Leksell Gamma Knife Perfexion
Radiology
181d
Cleared
Sep 03, 2015
Leksell GammaPlan
Radiology
76d
Cleared
Aug 04, 2015
Leksell Gamma Knife Icon
Radiology
55d
Cleared
May 09, 2014
LEKSELL GAMMA KNIFE PERFEXION
Radiology
170d
Cleared
May 24, 2012
LEKSELL GAMMA KNIFE PERFEXION
Radiology
69d
Cleared
Dec 21, 2010
LEKSELL GAMMAPLAN
Radiology
63d