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Anesthesiology

450 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
PROGEL™ Pleural Air Leak Sealant (P010047/S072)Neomend, Inc.2025-12-18
INSPIRE II UPPER AIRWAY STIMULATOR (P130008/S132)Inspire Medical Systems2025-12-17
Genio® System 2.1 (P240024/S002)Nyxoah S.A.2025-11-06
Inspire® Upper Airway Stimulation (P130008/S130)Inspire Medical Systems2025-10-22
Inspire Upper Airway Stimulation (P130008/S131)Inspire Medical Systems2025-10-21
Optune Lua® (P230042/S004)Novocure, GmbH2025-10-08
Genio® System 2.1 (P240024/S001)Nyxoah S.A.2025-10-03
AeroPace® System (P240012/S003)Lungpacer Medical USA, Inc.2025-09-29
Model 2740 Inspire Programmer; Model 2740S/C SleepSync Programming System (P130008/S129)Inspire Medical Systems2025-09-29
AeroPace® System (P240012/S002)Lungpacer Medical USA, Inc.2025-09-23
Optune Lua (P230042/S001)Novocure, GmbH2025-08-12
Genio® System 2.1 (P240024)Nyxoah S.A.2025-08-08
LifePulse High Frequency Ventilator (HFV) (P850064/S055)Bunnell, Inc.2025-07-25
MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR (P890057/S029)ZOLL Medical Corporation2025-07-23
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
PROGEL™ Pleural Air Leak Sealant (P010047/S071)Neomend, Inc.2025-06-18
Optune Lua (P230042/S002)Novocure, GmbH2025-06-04
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
PROGEL Pleural Air Leak Sealant (P010047/S070)Neomend, Inc.2025-05-09
remede System (P160039/S011)Respicardia2025-05-07
LungFit PH (P200044/S011)Beyond Air, Inc.2025-05-06
LungFit PH (P200044/S010)Beyond Air, Inc.2025-05-06
Inspire® Upper Airway Stimulation (UAS) (P130008/S120)Inspire Medical Systems2025-04-23
LungFit PH (P200044/S008)Beyond Air, Inc.2025-04-04
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
AeroPace® System (P240012/S001)Lungpacer Medical USA, Inc.2025-01-30
INSPIRE II UPPER AIRWAY STIMULATOR (P130008/S117)Inspire Medical Systems2025-01-14
Inspire® Upper Airway Stimulation (UAS) (P130008/S115)Inspire Medical Systems2024-12-10
AeroPace® System (P240012)Lungpacer Medical USA, Inc.2024-12-04
Zephyr Endobronchial Valve System (P180002/S029)Pulmonx Corporation2024-12-04
3100 High Frequency Oscillating Ventilator (HFOV), Vyaire Model 31008 Oscillatory Ventilator (P890057/S027)ZOLL Medical Corporation2024-11-15
Model 4063 Inspire Stimulation Lead, Model 4340 Inspire Sensing Lead (P130008/S114)Inspire Medical Systems2024-11-13
Optune Lua (P230042)Novocure, GmbH2024-10-15
LifePulse High Frequency Ventilator (P850064/S054)Bunnell, Inc.2024-09-19
Model 4063 Inspire Stimulation Lead, Model 4340 Inspire Sensing Lead (P130008/S113)Inspire Medical Systems2024-08-30
Zephyr Endobronchial Valve (EBV) System (P180002/S028)Pulmonx Corporation2024-08-23
Spiration® Valve System (P180007/S013)Gyrus Acmi, Inc.2024-08-16
Inspire Upper Airway Stimulation (UAS) System (P130008/S098)Inspire Medical Systems2024-08-01
Spiration Valve System Deployment Catheter and Loader (P180007/S012)Gyrus Acmi, Inc.2024-06-27
LifePulse High Frequency Ventilator (P850064/S052)Bunnell, Inc.2024-06-21
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
Zephyr Endobronchial Valve System (P180002/S027)Pulmonx Corporation2024-05-13
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
LungFit PH (P200044/S007)Beyond Air, Inc.2024-03-22
Zephyr Endobronchial Valve System (P180002/S025)Pulmonx Corporation2024-03-22
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
PROGEL™ Pleural Air Leak Sealant (P010047/S069)Neomend, Inc.2024-03-05
Zephyr Endobronchial Valve (EBV) System (P180002/S026)Pulmonx Corporation2024-03-01
3100 High Frequency Oscillating Ventilator (HFOV), Vyaire Model 31008 Oscillatory Ventilator (P890057/S028)ZOLL Medical Corporation2024-02-20
Inspire Model 3028 Implantable Pulse Generator (IPG) (P130008/S106)Inspire Medical Systems2024-01-19
LifePulse High Frequency Ventilator (P850064/S053)Bunnell, Inc.2023-12-28
LifePulse High Frequency Ventilator (P850064/S051)Bunnell, Inc.2023-12-28
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
remede System IPG (P160039/S009)Respicardia2023-11-09
LungFit PH (P200044/S005)Beyond Air, Inc.2023-10-20
Model 4340 Sensing Lead (P130008/S102)Inspire Medical Systems2023-10-18
LungFit PH (P200044/S004)Beyond Air, Inc.2023-09-29
Spiration Valve System (P180007/S011)Gyrus Acmi, Inc.2023-09-22
LungFit PH (P200044/S003)Beyond Air, Inc.2023-09-10
modified 4.0-LP funnel component (P180002/S024)Pulmonx Corporation2023-09-05
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
LifePulse High Frequency Ventilator (P850064/S050)Bunnell, Inc.2023-05-31
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
LungFit PH (P200044/S002)Beyond Air, Inc.2023-04-21
NeuRX Diaphragm Pacing System (DPS) (P200018)Synapse Biomedical, Inc.2023-03-31
remede® System (P160039/S008)Respicardia2023-03-28
Zephyr Valve Reigstry (ZEVR) (P180002/S022)Pulmonx Corporation2023-03-25
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
PROGEL™ Pleural Air Leak Sealant (P010047/S068)Neomend, Inc.2023-02-07
LifePulse High Frequency Ventilator (P850064/S049)Bunnell, Inc.2023-02-06
LungFit® PH (P200044/S001)Beyond Air, Inc.2022-12-28
Inspire II Upper Airway Stimulator (P130008/S093)Inspire Medical Systems2022-12-16
Model 2580 Patient Remote (P130008/S085)Inspire Medical Systems2022-09-12
PROGEL Pleural Air Leak Sealant (P010047/S067)Neomend, Inc.2022-09-06
Inspire Implantable Pulse Generator (IPG) (P130008/S088)Inspire Medical Systems2022-08-19
Model 3100A/B High Frequency Oscillatory Ventilator (P890057/S025)ZOLL Medical Corporation2022-07-22
Inspire Upper Airway Stimulation (UAS) (P130008/S076)Inspire Medical Systems2022-07-01
LungFit PH (P200044)Beyond Air, Inc.2022-06-28
Inspire Silicone Stimulation Lead, Inspire Silicone Sensing Lead (P130008/S084)Inspire Medical Systems2022-06-16
SVS Deployment Catheter and Loader (P180007/S009)Gyrus Acmi, Inc.2022-05-12
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
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