Galil Medical , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: IceSphere 1.5 CX Cryoablation Needle, IcePearl 2.1 CX L, IceForce 2.1 CX L, IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System
23
Total
23
Cleared
0
Denied
FDA 510(k) Regulatory Record - Galil Medical , Ltd. General & Plastic Surgery ✕
23 devices
Cleared
Jul 30, 2018
IceSphere 1.5 CX Cryoablation Needle
General & Plastic Surgery
28d
Cleared
Oct 11, 2016
IcePearl 2.1 CX L, IceForce 2.1 CX L
General & Plastic Surgery
22d
Cleared
Aug 28, 2015
IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation...
General & Plastic Surgery
28d
Cleared
Jul 02, 2014
ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE
General & Plastic Surgery
27d
Cleared
Mar 31, 2014
ICEROD CX CRYOABLATION NEEDLE
General & Plastic Surgery
24d
Cleared
Aug 28, 2012
ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK
General & Plastic Surgery
125d
Cleared
Jun 21, 2011
ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE
General & Plastic Surgery
78d
Cleared
Mar 20, 2007
ISIS
General & Plastic Surgery
28d
Cleared
Apr 27, 2006
SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA
General & Plastic Surgery
72d
Cleared
Feb 13, 2006
SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS
General & Plastic Surgery
25d
Cleared
Nov 18, 2005
SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA
General & Plastic Surgery
65d
Cleared
May 06, 2005
SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM)
General & Plastic Surgery
11d