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Inspire Medical Systems

131 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
INSPIRE II UPPER AIRWAY STIMULATOR (P130008/S132)Inspire Medical Systems2025-12-17
Inspire® Upper Airway Stimulation (P130008/S130)Inspire Medical Systems2025-10-22
Inspire Upper Airway Stimulation (P130008/S131)Inspire Medical Systems2025-10-21
Model 2740 Inspire Programmer; Model 2740S/C SleepSync Programming System (P130008/S129)Inspire Medical Systems2025-09-29
MODEL 3150 IMPLANTABLE PULSE GENERATOR (IPG) (P130008/S127)Inspire Medical Systems2025-07-21
Inspire® Upper Airway Stimulation (UAS) (P130008/S126)Inspire Medical Systems2025-06-18
Inspire Upper Airway Stimulation (UAS) (P130008/S116)Inspire Medical Systems2025-06-03
INSPIRE II UPPER AIRWAY STIMULATOR (P130008/S125)Inspire Medical Systems2025-05-30
INSPIRE II UPPER AIRWAY STIMULATOR (P130008/S122)Inspire Medical Systems2025-05-16
INSPIRE II UPPER AIRWAY STIMULATOR (P130008/S121)Inspire Medical Systems2025-05-09
Inspire® Upper Airway Stimulation (UAS) (P130008/S120)Inspire Medical Systems2025-04-23
Inspire II Upper Airway Stimulator (P130008/S119)Inspire Medical Systems2025-03-04
Inspire Upper Airway Stimulation (UAS) system (P130008/S118)Inspire Medical Systems2025-02-14
INSPIRE II UPPER AIRWAY STIMULATOR (P130008/S117)Inspire Medical Systems2025-01-14
Inspire® Upper Airway Stimulation (UAS) (P130008/S115)Inspire Medical Systems2024-12-10
Model 4063 Inspire Stimulation Lead, Model 4340 Inspire Sensing Lead (P130008/S114)Inspire Medical Systems2024-11-13
Model 4063 Inspire Stimulation Lead, Model 4340 Inspire Sensing Lead (P130008/S113)Inspire Medical Systems2024-08-30
Inspire Upper Airway Stimulation (UAS) System (P130008/S098)Inspire Medical Systems2024-08-01
Model 4063 Inspire Stimulation Lead, Model 4340 Inspire Sensing Lead (P130008/S112)Inspire Medical Systems2024-06-20
Inspire Model 3028 Implantable Pulse Generator (IPG) (P130008/S111)Inspire Medical Systems2024-05-30
Inspire Patient Remote (P130008/S110)Inspire Medical Systems2024-05-16
Model 4063 Stimulation Lead and 4340 Sensing Lead (P130008/S109)Inspire Medical Systems2024-04-24
Model 2740 Inspire Physician Programmer (P130008/S108)Inspire Medical Systems2024-04-16
Model 3028 Implantable Pulse Generator (IPG) (P130008/S103)Inspire Medical Systems2024-03-21
Inspire Model 3028 Implantable Pulse Generator (IPG) (P130008/S107)Inspire Medical Systems2024-03-13
Inspire Model 3028 Implantable Pulse Generator (IPG) (P130008/S106)Inspire Medical Systems2024-01-19
Model 2740 and 2740C Cable Interference (P130008/S101)Inspire Medical Systems2023-12-15
4340 Sensing Lead and 4063 Stimulation Lead (P130008/S105)Inspire Medical Systems2023-12-08
Inspire Upper Airway Stimulation (UAS) (P130008/S104)Inspire Medical Systems2023-11-17
Model 4340 Sensing Lead (P130008/S102)Inspire Medical Systems2023-10-18
INSPIRE II UPPER AIRWAY STIMULATOR (P130008/S100)Inspire Medical Systems2023-08-15
Inspire UAS High AHI/High BMI (P130008/S099)Inspire Medical Systems2023-08-04
SleepSync Programmer (P130008/S092)Inspire Medical Systems2023-06-27
Inspire Model 3028 Implantable Pulse Generator (IPG) and Model 4340 Inspire Sensing Lead (P130008/S097)Inspire Medical Systems2023-06-20
Inspire Upper Airway Stimulation System (P130008/S090)Inspire Medical Systems2023-06-08
Inspire® Upper Airway Stimulation System (P130008/S096)Inspire Medical Systems2023-05-19
Model 2740 Programmer Cable Printed Circuit Board Assembly (P130008/S095)Inspire Medical Systems2023-04-28
Inspire Upper Airway Stimulation (P130008/S089)Inspire Medical Systems2023-03-20
Inspire Model 3028 Implantable Pulse Generator (IPG) (P130008/S094)Inspire Medical Systems2023-03-08
Inspire II Upper Airway Stimulator (P130008/S093)Inspire Medical Systems2022-12-16
Model 2580 Patient Remote (P130008/S085)Inspire Medical Systems2022-09-12
Inspire Implantable Pulse Generator (IPG) (P130008/S088)Inspire Medical Systems2022-08-19
Inspire Upper Airway Stimulation (UAS) (P130008/S076)Inspire Medical Systems2022-07-01
Inspire Silicone Stimulation Lead, Inspire Silicone Sensing Lead (P130008/S084)Inspire Medical Systems2022-06-16
Silicone Stimulation Lead, Silicone Sensing Lead (P130008/S074)Inspire Medical Systems2022-04-29
Inspire Respiratory Sensing Lead and Inspire Stimulation Lead (P130008/S083)Inspire Medical Systems2022-04-07
Inspire Patient Remote (P130008/S082)Inspire Medical Systems2022-04-01
Inspire Model 2580 Sleep Remote (P130008/S080)Inspire Medical Systems2022-03-16
Inspire Model 4340 Respiratory Sensing Lead (P130008/S081)Inspire Medical Systems2022-03-14
Inspire Model 2740 Programmer (P130008/S079)Inspire Medical Systems2022-03-10
Inspire Implantable Pulse Generator (IPG) Model 2580 Patient Remote (P130008/S078)Inspire Medical Systems2022-02-11
Inspire Implantable Pulse Generator (IPG) (P130008/S077)Inspire Medical Systems2022-02-02
Inspire Medical Systems, Model 2580 Patient Programmer (P130008/S069)Inspire Medical Systems2021-12-18
Inspire Programmer System (P130008/S072)Inspire Medical Systems2021-12-10
Inspire Model 4340 Respiratory Sensing Lead (P130008/S075)Inspire Medical Systems2021-11-03
Inspire II Upper Airway Stimulator (P130008/S065)Inspire Medical Systems2021-09-21
Inspire II Upper Airway Stimulator (P130008/S073)Inspire Medical Systems2021-09-10
Physician Programmer Cable (P130008/S068)Inspire Medical Systems2021-08-31
Inspire Implantable Pulse Generator (IPG) (P130008/S071)Inspire Medical Systems2021-08-12
Inspire Upper Airway Stimulation (UAS) (P130008/S067)Inspire Medical Systems2021-06-24
Inspire Upper Airway Stimulation (UAS) (P130008/S066)Inspire Medical Systems2021-06-11
Inspire Upper Airway Stimulation System (P130008/S064)Inspire Medical Systems2021-04-09
Inspire II Upper Airway Stimulator (P130008/S063)Inspire Medical Systems2021-03-12
Inspire Programmer System (P130008/S056)Inspire Medical Systems2021-02-12
Inspire II Upper Airway Stimulator (P130008/S061)Inspire Medical Systems2020-12-07
Inspire Upper Airway Stimulator (P130008/S057)Inspire Medical Systems2020-11-27
Inspire II Upper Airway Stimulator (P130008/S055)Inspire Medical Systems2020-11-16
Inspire IV IPG (P130008/S062)Inspire Medical Systems2020-10-14
Inspire IV IPG (P130008/S060)Inspire Medical Systems2020-09-29
Inspire Upper Airway Stimulation (P130008/S059)Inspire Medical Systems2020-09-24
Inspire Implantable Pulse Generator (P130008/S058)Inspire Medical Systems2020-09-16
Inspire Respiratory Sensing Lead (P130008/S054)Inspire Medical Systems2020-07-20
Inspire IV IPG (P130008/S053)Inspire Medical Systems2020-06-18
Inspire Upper Airway Stimulation (P130008/S052)Inspire Medical Systems2020-06-12
Implantable Pulse Generator (IPG) (P130008/S047)Inspire Medical Systems2020-05-03
Inspire Upper Airway Stimulation (P130008/S039)Inspire Medical Systems2020-04-14
Inspire Stimulation and Sensing Leads (P130008/S050)Inspire Medical Systems2020-03-30
Inspire II Upper Airway Stimulator (P130008/S051)Inspire Medical Systems2020-03-02
Inspire Upper Airway Stimulation System (P130008/S049)Inspire Medical Systems2020-01-16
Implantable Pulse Generator, Sensing Lead, and Stimulation Lead (P130008/S048)Inspire Medical Systems2020-01-10
Inspire Upper Airway Stimulation System (P130008/S046)Inspire Medical Systems2019-09-11
Inspire Upper Airway Stimulation (UAS) (P130008/S043)Inspire Medical Systems2019-08-06
Inspire Upper Airway Stimulation System (P130008/S045)Inspire Medical Systems2019-07-25
Inspire Upper Airway Stimulation System (P130008/S041)Inspire Medical Systems2019-07-22
Inspire II Upper Airway Stimulator (P130008/S044)Inspire Medical Systems2019-06-21
Inspire Upper Airway Stimulator (P130008/S040)Inspire Medical Systems2019-03-06
Model 4340 Respiratory Sensing Lead (P130008/S031)Inspire Medical Systems2019-01-28
Model 3028 Implantable Pulse Generator (P130008/S037)Inspire Medical Systems2019-01-24
Stimulator, Hypoglossal Nerve, Implanted, Apnea (P130008/S038)Inspire Medical Systems2019-01-09
Inspire Model 4323 Sensing Lead (P130008/S036)Inspire Medical Systems2018-11-19
Inspire Model 2740 Physician Programmer (P130008/S034)Inspire Medical Systems2018-11-01
INSPIRE II UPPER AIRWAY STIMULATOR (P130008/S035)Inspire Medical Systems2018-09-14
Inspire Upper Airway Stimulator (P130008/S033)Inspire Medical Systems2018-05-15
Inspire Upper Airway Stimulation Therapy (P130008/S029)Inspire Medical Systems2018-05-11
Pressure Sensor Test Limits (P130008/S032)Inspire Medical Systems2018-03-07
Inspire IV IPG (P130008/S028)Inspire Medical Systems2017-12-08
Inspire IV IPG (P130008/S027)Inspire Medical Systems2017-11-08
Inspire II Upper Airway Stimulator (P130008/S022)Inspire Medical Systems2017-09-11
MODEL 2740 INSPIRE PROGRAMMER SYSTEM (P130008/S020)Inspire Medical Systems2017-08-02
Sensing Lead (P130008/S023)Inspire Medical Systems2017-07-28
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Every clearance here is in the API, with alerts when new ones post.