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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 7 of 7 Results
ProductCode: GEH Applicant: GALIL MEDICAL INC. Decision Date To: 05/23/2024
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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 Galil Medical Inc. K203032 11/02/2020
icefx cryoablation system Galil Medical Inc. K181153 05/15/2018
visual-ice mri cryoblation console, visual-ice mri junction box assembly, visual-ice mri mobile connection panel Galil Medical Inc. K173037 11/21/2017
visual-ice cryoablation system, software revision 1.3.1 GALIL MEDICAL INC. K143564 03/05/2015
visual-ice cryoablation system GALIL MEDICAL INC. K123865 02/06/2013
visual-ice cryoablation system GALIL MEDICAL INC. K113860 03/12/2012
iceedge 2.4 cryoablation needle,iceedge 2.4 cryoablation needle multipack GALIL MEDICAL INC. K111859 10/07/2011
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