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Galil Medical, Inc.

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K203032 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 NeedleGEH2020-11-02 View
510(k) K200061 HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)NEY2020-07-09 View
510(k) K181153 ICEfx Cryoablation SystemGEH2018-05-15 View
510(k) K173037 Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection PanelGEH2017-11-21 View
510(k) K123865 VISUAL-ICE CRYOABLATION SYSTEMGEH2013-02-06 View
510(k) K113860 VISUAL-ICE CRYOABLATION SYSTEMGEH2012-03-12 View
510(k) K111859 ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACKGEH2011-10-07 View
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