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Insightec, Ltd.

21 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Exablate 2000 System Magnetic Resonance Guided Focused Ultrasound Ablation of Uterine Fibroids (P040003/S022)Insightec, Ltd.2025-07-23
Exablate 2100/2100V1 System (P040003/S021)Insightec, Ltd.2018-08-16
InSightec ExAblate System (P040003/S019)Insightec, Ltd.2016-10-28
EXABLATE 2000 SYSTEM (P040003/S018)Insightec, Ltd.2016-08-26
EXABLATE 2000 SYSTEM (P040003/S017)Insightec, Ltd.2016-06-27
EXABLATE (P040003/S016)Insightec, Ltd.2015-10-05
EXABLATE (P040003/S015)Insightec, Ltd.2015-08-31
EXABLATE SYSTEM (P040003/S014)Insightec, Ltd.2014-06-13
EXABLATE 2000/2100 (P040003/S013)Insightec, Ltd.2013-12-16
EXABLATE SYSTEM (P040003/S012)Insightec, Ltd.2012-09-07
EXABLATE DEVICE (P040003/S011)Insightec, Ltd.2012-05-01
EXABLATE (P040003/S010)Insightec, Ltd.2011-12-08
EXABLATE 2000/2100 1.5 AND 3T (P040003/S009)Insightec, Ltd.2011-08-09
EXABLATE (P040003/S008)Insightec, Ltd.2010-08-23
EXABLATE 2100 SYSTEM (P040003/S007)Insightec, Ltd.2010-04-19
EXABLATE 2100 SYSTEM (P040003/S006)Insightec, Ltd.2009-12-22
EXABLATE 2000 SYSTEM (P040003/S005)Insightec, Ltd.2009-03-04
EXABLATE 2000, VERSION 4.22 (P040003/S004)Insightec, Ltd.2007-08-02
EXABLATE 2000 (P040003/S002)Insightec, Ltd.2007-02-27
EXABLATE 2000 MRI GUIDED FOCUSED ULTRASOUND SYSTEM (P040003/S001)Insightec, Ltd.2005-12-30
EXABLATE 2000 SYSTEM (P040003)Insightec, Ltd.2004-10-22

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Every clearance here is in the API, with alerts when new ones post.