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Ev3 Neurovascular

41 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Onyx Liquid Embolic System (LES) (P030004/S035)Ev3 Neurovascular2025-12-08
Apollo™ Onyx™ Delivery Micro Catheter (P030004/S037)Ev3 Neurovascular2024-12-19
Apollo™ Onyx™ Delivery Micro Catheter (P030004/S036)Ev3 Neurovascular2024-11-07
Apollo™ Onyx™ Delivery Micro Catheter (P030004/S034)Ev3 Neurovascular2024-09-20
Onyx™ Liquid Embolic System (P030004/S033)Ev3 Neurovascular2024-07-26
Apollo™ Onyx™ Delivery Micro Catheter 1.5 cm, Apollo™ Onyx™ Delivery Micro Catheter 3.0 cm (P030004/S031)Ev3 Neurovascular2024-04-16
Onyx™ Liquid Embolic System (P030004/S030)Ev3 Neurovascular2023-11-03
Apollo Onyx Delivery Micro Catheter 1.5cm, Apollo Onyx Delivery Micro Catheter 3.0cm (P030004/S029)Ev3 Neurovascular2022-07-28
Onyx™ Liquid Embolic System (P030004/S027)Ev3 Neurovascular2021-09-16
Apollo™ Onyx™ Delivery Micro Catheter 1.5 cm, Apollo™ Onyx™ Delivery Micro Catheter 3.0 cm (P030004/S028)Ev3 Neurovascular2021-09-14
Apollo Onyx Delivery Micro Catheter (P030004/S026)Ev3 Neurovascular2021-03-18
Onyx Liquid Embolic System (P030004/S025)Ev3 Neurovascular2020-11-13
Apollo Onyx Delivery Micro Catheter (P030004/S024)Ev3 Neurovascular2020-06-29
Apollo Onyx Delivery Micro Catheter (P030004/S017)Ev3 Neurovascular2020-06-15
Apollo Onyx Delivery Micro Catheter (P030004/S023)Ev3 Neurovascular2020-02-28
Onyx Liquid Embolic System and Apollo Onyx Delivery Micro Catheter (P030004/S022)Ev3 Neurovascular2019-12-19
Apollo Onyx Delivery Microcatheter (P030004/S021)Ev3 Neurovascular2019-12-10
Onyx Liquid Embolic System (P030004/S020)Ev3 Neurovascular2019-07-24
Onyx Liquid Embolic System (P030004/S019)Ev3 Neurovascular2019-06-17
Onyx Liquid Embolic System (P030004/S018)Ev3 Neurovascular2019-06-06
Apollo Onyx Delivery Micro Catheter (P030004/S016)Ev3 Neurovascular2018-12-27
Onyx Liquid Embolic System (P030004/S015)Ev3 Neurovascular2018-06-06
Onyx Liquid Embolic System (P030004/S014)Ev3 Neurovascular2018-02-06
Apollo Onyx Delivery Micro Catheter, 1.5cm, Straight/Apollo Onyx Delivery Micro Catheter, 3.0cm, Straight (P030004/S013)Ev3 Neurovascular2017-10-17
ONYX LIQUID EMBOLIC SYSTEM (P030004/S012)Ev3 Neurovascular2017-01-25
ONYX LIQUID EMBOLIC SYSTEM (P030004/S011)Ev3 Neurovascular2016-09-20
ONYX LIQUID EMBOLIC SYSTEM (P030004/S010)Ev3 Neurovascular2016-03-31
ONYX 18, ONYX LIQUID EMBOLIC SYSTEM, ONYX 34,ONYX LIQUID EMBOLIC SYSTEM, APPOLLO ONYX DELIVERY MICRO CATHETER 1.5CM, STR (P030004/S009)Ev3 Neurovascular2015-12-18
ONYX LIQUID EMBOLIC SYSTEM (P030004/S006)Ev3 Neurovascular2014-05-27
ONYX 18LES & ONYX 34 LES (P030004/S008)Ev3 Neurovascular2013-10-09
ONYX LIQUID EMBOLIC SYSTEM (LES) (P030004/S007)Ev3 Neurovascular2013-07-19
ONYX LIQUID EMBOLIC SYSTEM (P030004/S005)Ev3 Neurovascular2012-04-05
ONYX LIQUID EMBOLIC SYSTEM (P030004/S003)Ev3 Neurovascular2007-10-09
ONYX LIQUID EMBOLIC SYSTEM (P030004/S002)Ev3 Neurovascular2006-11-29
ONYX LIQUID EMBOLIC SYSTEM (P030004/S001)Ev3 Neurovascular2006-06-22
ONYX LIQUID EMBOLIC SYSTEM (P030004)Ev3 Neurovascular2005-07-21

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