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Medtronic

227 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
HeartWare HVAD System (P100047/S227)Medtronic2025-07-09
HeartWare­™ Ventricular Assist System (HVAD) (P100047/S230)Medtronic2025-06-26
HeartWare™ Ventricular Assist System (HVAD) (P100047/S229)Medtronic2025-06-05
HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S228)Medtronic2025-06-04
HeartWare HVAD System (P100047/S226)Medtronic2025-05-05
HeartWare® HVAD System (P100047/S225)Medtronic2025-04-24
HeartWare HVAD System (P100047/S224)Medtronic2025-04-02
HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S222)Medtronic2025-03-13
HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S221)Medtronic2024-11-25
HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S219)Medtronic2024-09-26
HeartWare® HVAD System (P100047/S220)Medtronic2024-08-30
Heart Ware HVAD System (P100047/S218)Medtronic2024-08-06
HeartWare HVAD System (P100047/S217)Medtronic2024-07-03
HeartWare™ HVAD System (P100047/S215)Medtronic2024-04-29
HeartWare® HVAD System (P100047/S216)Medtronic2024-03-21
HeartWare HVAD System (P100047/S214)Medtronic2023-10-18
HeartWare™ Ventricular Assist System or HeartWare™ System (P100047/S211)Medtronic2023-08-20
HeartWare® Ventricular Assist System (P100047/S212)Medtronic2023-07-07
HeartWare® Ventricular Assist System, HeartWare® System (P100047/S210)Medtronic2023-06-21
HeartWare® Ventricular Assist System (P100047/S209)Medtronic2023-04-26
HeartWare™ Ventricular Assist System (P100047/S206)Medtronic2023-03-08
Pioneer 2.0 HVAD Controller (P100047/S208)Medtronic2023-03-03
HeartWare HVAD System (P100047/S207)Medtronic2023-02-15
HeartWare Ventricular Assist System (P100047/S204)Medtronic2023-02-13
HeartWare® Ventricular Assist System, HeartWare® System (P100047/S205)Medtronic2023-02-02
HeartWare® Ventricular Assist System (P100047/S202)Medtronic2022-10-31
HeartWare HVAD System (P100047/S196)Medtronic2022-09-30
HeartWare HVAD System (P100047/S200)Medtronic2022-09-08
HeartWare Ventricular Assist System (P100047/S201)Medtronic2022-06-28
HeartWare Ventricular Assist System (P100047/S199)Medtronic2022-06-24
HeartWare Ventricular Assist System (P100047/S198)Medtronic2022-06-16
HeartWare Ventricular Assist System (P100047/S184)Medtronic2022-05-18
HeartWare® Ventricular Assist System (P100047/S197)Medtronic2022-05-10
HeartWare Ventricular Assist (HVAD) System (P100047/S195)Medtronic2022-03-16
Heartware Ventricular Assist System (P100047/S194)Medtronic2022-03-15
HeartWare® HVAD System (P100047/S193)Medtronic2022-03-11
HeartWare Ventricular Assist System (P100047/S192)Medtronic2022-03-01
HeartWare® Ventricular Assist System or HeartWare® System (P100047/S191)Medtronic2021-11-23
HeartWare Ventricular Assist System (P100047/S183)Medtronic2021-11-22
HeartWare® Ventricular Assist System (P100047/S190)Medtronic2021-10-18
HeartWare HVAD System (P100047/S189)Medtronic2021-10-15
HeartWare Ventricular Assist System (P100047/S173)Medtronic2021-09-14
HeartWare HVAD System (P100047/S174)Medtronic2021-08-12
HeartWare HVAD System (P100047/S188)Medtronic2021-08-10
HeartWare Ventricular Assist System (P100047/S186)Medtronic2021-08-03
HeartWare Ventricular Assist System (P100047/S185)Medtronic2021-07-22
HeartWare Ventricular Assist System (P100047/S178)Medtronic2021-06-28
HeartWare Ventricular Assist System (P100047/S182)Medtronic2021-06-23
HeartWare Ventricular Assist System (P100047/S181)Medtronic2021-06-21
HeartWare HVAD System (P100047/S180)Medtronic2021-06-09
HeartWare Left Ventricular Assist System (P100047/S177)Medtronic2021-06-09
HeartWare Ventricular Assist System (P100047/S179)Medtronic2021-05-24
HeartWare HVAD System (P100047/S176)Medtronic2021-03-30
HeartWare HVAD System (P100047/S175)Medtronic2021-03-11
HeartWare HVAD System (P100047/S149)Medtronic2021-02-12
HeartWare HVAD System (P100047/S169)Medtronic2020-12-21
HeartWare Ventricular Assist System (P100047/S159)Medtronic2020-11-23
HeartWare Left Ventricular Assist System (P100047/S163)Medtronic2020-11-18
HeartWare Ventricular Assist System (P100047/S172)Medtronic2020-10-06
HeartWare Ventricular Assist System (P100047/S171)Medtronic2020-09-30
HeartWare Ventricular Assist System (P100047/S170)Medtronic2020-09-04
HeartWare HVAD System (P100047/S166)Medtronic2020-09-03
HeartWare HVAD System (P100047/S151)Medtronic2020-08-06
HeartWare Ventricular Assist System (P100047/S168)Medtronic2020-07-20
HeartWare Ventricular Assist System (P100047/S167)Medtronic2020-07-15
HeartWare HVAD System (P100047/S132)Medtronic2020-07-09
HeartWare Ventricular Assist System (P100047/S164)Medtronic2020-06-22
HeartWare Ventricular Assist System (P100047/S162)Medtronic2020-06-03
HeartWare HVAD System (P100047/S142)Medtronic2020-05-07
HeartWare Ventricular Assist System (P100047/S161)Medtronic2020-05-06
HeartWare Ventricular Assist System (P100047/S154)Medtronic2020-05-05
HeartWare HVAD System (P100047/S144)Medtronic2020-04-24
HeartWare Ventricular Assist System (P100047/S157)Medtronic2020-04-08
HeartWare Ventricular Assist System (P100047/S155)Medtronic2020-04-01
HeartWare Ventricular Assist System (P100047/S156)Medtronic2020-03-30
HeartWare Ventricular Assist System (P100047/S158)Medtronic2020-03-20
HeartWare Ventricular Assist System (P100047/S153)Medtronic2020-03-03
HeartWare Ventricular Assist System (P100047/S152)Medtronic2020-02-18
HeartWare HVAD System (P100047/S150)Medtronic2020-01-27
HeartWare HVAD System (P100047/S131)Medtronic2019-11-06
HeartWare HVAD System (P100047/S139)Medtronic2019-10-21
HeartWare HVAD System (P100047/S148)Medtronic2019-10-18
HeartWare Ventricular Assist System (P100047/S147)Medtronic2019-10-07
HeartWare Left Ventricular Assist Device System (P100047/S145)Medtronic2019-09-06
HeartWare Ventricular Assist System (P100047/S143)Medtronic2019-08-23
HeartWare HVAD System (P100047/S138)Medtronic2019-07-09
HeartWare Ventricular Assist System (P100047/S141)Medtronic2019-07-05
HeartWare HVAD System (P100047/S134)Medtronic2019-07-02
HeartWare Left Ventricular Assist Device System (P100047/S140)Medtronic2019-06-28
HeartWare Left Ventricular Assist System (P100047/S129)Medtronic2019-06-06
HeartWare Ventricular Assist System (P100047/S136)Medtronic2019-03-26
HeartWare Left Ventricular Assist Device System (P100047/S137)Medtronic2019-03-26
HeartWare Ventricular Assist System (HVAD) (P100047/S135)Medtronic2019-03-13
HeartWare Ventricular Assist System (P100047/S133)Medtronic2019-02-21
HeartWare Left Ventricular Assist System (P100047/S120)Medtronic2018-11-15
HeartWare Ventricular Assist System (P100047/S130)Medtronic2018-10-23
HeartWare Ventricular Assist System (P100047/S127)Medtronic2018-09-18
HeartWare Left Ventricular Assist System (P100047/S122)Medtronic2018-08-13
HeartWare Ventricular Assist System (P100047/S126)Medtronic2018-08-10
HeartWare HVAD System (P100047/S124)Medtronic2018-08-06
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Every clearance here is in the API, with alerts when new ones post.