Medical Device Manufacturer · US , Washington, Dc , DC

Galil Medical , Ltd. - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 1998

Recent clearances: IceSphere 1.5 CX Cryoablation Needle

23
Total
23
Cleared
0
Denied

Galil Medical , Ltd. has 23 FDA 510(k) cleared general & plastic surgery devices. Based in Washington, Dc, US.

Historical record: 23 cleared submissions from 1998 to 2018.

Browse the complete list of FDA 510(k) cleared general & plastic surgery devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Galil Medical, Inc. as regulatory consultant.

FDA 510(k) Regulatory Record - Galil Medical , Ltd.

23 devices
1-23 of 23
Cleared Jul 30, 2018
IceSphere 1.5 CX Cryoablation Needle
K181741 · GEH
General & Plastic Surgery · 28d
Cleared Oct 11, 2016
IcePearl 2.1 CX L, IceForce 2.1 CX L
K162599 · GEH
General & Plastic Surgery · 22d
Cleared Aug 28, 2015
IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation...
K152133 · GEH
General & Plastic Surgery · 28d
Cleared Jul 02, 2014
ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE
K141485 · GEH
General & Plastic Surgery · 27d
Cleared Mar 31, 2014
ICEROD CX CRYOABLATION NEEDLE
K140584 · GEH
General & Plastic Surgery · 24d
Cleared Aug 28, 2012
ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK
K121251 · GEH
General & Plastic Surgery · 125d
Cleared Jun 21, 2011
ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE
K110946 · GEH
General & Plastic Surgery · 78d
Cleared Mar 20, 2007
ISIS
K070482 · GEH
General & Plastic Surgery · 28d
Cleared Apr 27, 2006
SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA
K060390 · GEH
General & Plastic Surgery · 72d
Cleared Feb 13, 2006
SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS
K060144 · GEH
General & Plastic Surgery · 25d
Cleared Nov 18, 2005
SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA
K052530 · GEH
General & Plastic Surgery · 65d
Cleared May 06, 2005
SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM)
K051052 · GEH
General & Plastic Surgery · 11d
Cleared Oct 14, 2004
SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRCH 2024...
K042667 · GEH
General & Plastic Surgery · 15d
Cleared May 23, 2003
SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM
K031117 · GEH
General & Plastic Surgery · 45d
Cleared Jul 03, 2002
SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3
K021261 · GEH
General & Plastic Surgery · 75d
Cleared Jan 29, 2002
SEEDNET, MODEL FP6T5, FP5T5, FP5T3
K011950 · GEH
General & Plastic Surgery · 222d
Cleared Oct 30, 2001
CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1
K012497 · GEH
General & Plastic Surgery · 88d
Cleared May 03, 2001
SEEDNET, MODELS FP6T5, FP5T5, FP5T3
K010991 · GEH
General & Plastic Surgery · 30d
Cleared Oct 31, 2000
SEEDNET, MODEL EP6T5, EP5E5
K003065 · GEH
General & Plastic Surgery · 29d
Cleared Feb 18, 2000
CRYO-HIT
K993965 · GEH
General & Plastic Surgery · 87d
Cleared Jul 27, 1999
CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5
K991517 · GEH
General & Plastic Surgery · 88d
Cleared Jul 12, 1999
CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2,...
K991272 · GEH
General & Plastic Surgery · 90d
Cleared Jul 01, 1998
CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5
K980913 · GEI
General & Plastic Surgery · 113d
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