Galil Medical, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Galil Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle, HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS), ICEfx Cryoablation System
8
Total
8
Cleared
0
Denied
Galil Medical, Inc. has 8 FDA 510(k) cleared medical devices. Based in Lake Jackson, US.
Historical record: 8 cleared submissions from 2011 to 2020. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by Galil Medical, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Galil Medical, Inc.
8 devices
Cleared
Nov 02, 2020
IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX...
General & Plastic Surgery
28d
Cleared
Jul 09, 2020
HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart,...
General & Plastic Surgery
178d
Cleared
May 15, 2018
ICEfx Cryoablation System
General & Plastic Surgery
14d
Cleared
Nov 21, 2017
Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly,...
General & Plastic Surgery
54d
Cleared
Mar 05, 2015
Visual-ICE Cryoablation System, Software Revision 1.3.1
General & Plastic Surgery
79d
Cleared
Feb 06, 2013
VISUAL-ICE CRYOABLATION SYSTEM
General & Plastic Surgery
51d
Cleared
Mar 12, 2012
VISUAL-ICE CRYOABLATION SYSTEM
General & Plastic Surgery
73d
Cleared
Oct 07, 2011
ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK
General & Plastic Surgery
99d