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Obstetrics/Gynecology

632 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
Cerene® Cryotherapy Device (P180032/S022)Channel Medsystems, Inc.2025-12-18
NovaSure Model 10 RF Controller (P010013/S094)Hologic, Inc.2025-12-17
INTERCEED™ Absorbable Adhesion Barrier (P880047/S068)ETHICON, Inc.2025-12-12
GYNECARE INTERCEED 3INX4IN(7.6CMX10.2CM); GYNECARE INTERCEED 5INX6IN(12.7CMX15.2CM); GYNECARE INTERCEED 3INX2IN(7.6CMX5. (P880047/S067)ETHICON, Inc.2025-10-09
GYNECARE INTERCEED™ Absorbable Adhesion Barrier (P880047/S066)ETHICON, Inc.2025-09-24
Womed Leaf Resorbable Adhesion Barrier (P240015)Womed Sas2025-09-09
GYNECARE INTERCEED™ Absorbable Adhesion Barrier (P880047/S065)ETHICON, Inc.2025-09-04
Exablate 2000 System Magnetic Resonance Guided Focused Ultrasound Ablation of Uterine Fibroids (P040003/S022)Insightec, Ltd.2025-07-23
Minerva Endometrial Ablation System (P140013/S016)Axora Medical, Inc.2025-04-14
Gynecare Interceed™ Absorbable Adhesion Barrier (P880047/S063)ETHICON, Inc.2025-01-30
Mara Water Vapor Ablation System (P160047/S039)CooperSurgical, Inc.2025-01-07
GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S062)ETHICON, Inc.2024-12-19
Cerene Cryotherapy Device (P180032/S020)Channel Medsystems, Inc.2024-12-12
Minerva ES Endometrial Ablation System (P140013/S017)Axora Medical, Inc.2024-12-05
Filshie Clip (Mark VI) System (P920046/S015)Femcare , Ltd.2024-12-03
Cerene Cryotherapy Device (P180032/S019)Channel Medsystems, Inc.2024-11-22
Cerene Cryotherapy Device (P180032/S021)Channel Medsystems, Inc.2024-10-17
Filshie Clip (Mark VI) System (P920046/S014)Femcare , Ltd.2024-09-16
NovaSure Impedance Controlled Endometrial Ablation System (P010013/S093)Hologic, Inc.2024-09-06
GYNECARE INTERCEED™ Absorbable Adhesion Barrier (P880047/S061)ETHICON, Inc.2024-08-27
Adept Adhesion Reduction Solution (P050011/S009)Baxter Healthcare Corp2024-08-23
NovaSure Impedance Controlled Endometrial Ablation System (P010013/S092)Hologic, Inc.2024-07-23
Cerene Cryotherapy Device (P180032/S018)Channel Medsystems, Inc.2024-07-17
Minitouch 3.8 Era System (Minitouch System) (P230002/S001)Microcube, LLC2024-07-16
MARA Water Vapor Ablation System (P160047/S035)CooperSurgical, Inc.2024-07-11
MARA Water Vapor Ablation System (P160047/S038)CooperSurgical, Inc.2024-07-09
GYNECARE INTERCEED ™ Absorbable Adhesion Barrier (P880047/S060)ETHICON, Inc.2024-06-13
GYNECARE INTERCEED™ Absorbable Adhesion Barrier (P880047/S059)ETHICON, Inc.2024-05-16
MARA Water Vapor Ablation System (P160047/S036)CooperSurgical, Inc.2024-05-10
Cerene Cryotherapy Device (Model Number FGS-7000) (P180032/S016)Channel Medsystems, Inc.2024-04-11
GYNECARE INTERCEED™ Absorbable Adhesion Barrier (P880047/S058)ETHICON, Inc.2024-03-25
Minerva Endometrial Ablation System (P140013/S015)Axora Medical, Inc.2024-01-24
Minerva Endometrial Ablation System (P140013/S014)Axora Medical, Inc.2023-12-18
Filshie Clip System (P920046/S013)Femcare , Ltd.2023-12-18
GYNECARE INTERCEED™ Absorbable Adhesion Barrier (P880047/S057)ETHICON, Inc.2023-12-11
Mater Water Vapor System - Model # GEA-SYS-16-0500, Mara Water Vapor Probe Kit - Model # DDK-16-050, Mara Console - Mode (P160047/S034)CooperSurgical, Inc.2023-12-08
Cerene® Cryotherapy Device (P180032/S015)Channel Medsystems, Inc.2023-11-16
Cerene® Cryotherapy Device (P180032/S014)Channel Medsystems, Inc.2023-11-14
GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S055)ETHICON, Inc.2023-11-14
GYNECARE INTERCEED™ Absorbable Adhesion Barrier (P880047/S056)ETHICON, Inc.2023-11-01
NovaSure Impedance Controlled Endometrial Ablation System (P010013/S091)Hologic, Inc.2023-10-27
MARA Water Vapor Ablation System (P160047/S033)CooperSurgical, Inc.2023-10-25
NovaSure Impedance Controlled Endometrial Ablation System (P010013/S090)Hologic, Inc.2023-09-22
Minitouch 3.8 Era System (Minitouch System) (P230002)Microcube, LLC2023-07-28
Mara Water Vapor Ablation System (P160047/S031)CooperSurgical, Inc.2023-07-28
Mara Water Vapor Ablation System (P160047/S032)CooperSurgical, Inc.2023-07-27
Cerene Cryotherapy Device (P180032/S013)Channel Medsystems, Inc.2023-07-17
Mara Water Vapor Ablation System (P160047/S030)CooperSurgical, Inc.2023-06-30
Cerene Cryotherapy Device (P180032/S012)Channel Medsystems, Inc.2023-04-19
Mara Water Vapor Ablation System; Mara Water Vapor System; Mara Console (P160047/S029)CooperSurgical, Inc.2023-03-13
GYNECARE INTERCEED™ Absorbable Adhesion Barrier (P880047/S054)ETHICON, Inc.2023-02-28
Mara Water Vapor Ablation System (P160047/S028)CooperSurgical, Inc.2023-01-19
Cerene® Cryotherapy Device (P180032/S011)Channel Medsystems, Inc.2023-01-17
GYNECARE INTERCEED™ Absorbable Adhesion Barrier (P880047/S052)ETHICON, Inc.2022-12-20
Mara Water Vapor Ablation System (P160047/S027)CooperSurgical, Inc.2022-12-12
NovaSure Impedance Controlled Endometrial Ablation System (P010013/S089)Hologic, Inc.2022-12-01
NovaSure Impedance Controlled Endometrial Ablation System (P010013/S088)Hologic, Inc.2022-11-02
NovaSure Impedance Controlled Endometrial Ablation System (P010013/S087)Hologic, Inc.2022-08-04
Gynecare Interceed Absorbable Adhesion Barrier (P880047/S050)ETHICON, Inc.2022-07-08
GYNECARE INTERCEED™ Absorbable Adhesion Barrier (P880047/S046)ETHICON, Inc.2022-06-15
Cerene Cryotherapy Device (P180032/S010)Channel Medsystems, Inc.2022-05-31
Genesys HTA System (P000040/S042)Axora Medical, Inc.2022-05-26
GYNECARE INTERCEED™ Absorbable Adhesion Barrier (P880047/S047)ETHICON, Inc.2022-03-07
Mara Water Vapor System (P160047/S026)CooperSurgical, Inc.2022-01-25
GYNECARE INTERCEED™ Absorbable Adhesion Barrier (P880047/S043)ETHICON, Inc.2022-01-21
GYNECARE INTERCEED™ Absorbable Adhesion Barrier (P880047/S049)ETHICON, Inc.2022-01-20
Minerva® Endometrial Ablation System (P140013/S013)Axora Medical, Inc.2022-01-11
Filshie Clip (Mark VI) System (P920046/S012)Femcare , Ltd.2022-01-06
NovaSure Impedance Controlled Endometrial Ablation System (P010013/S085)Hologic, Inc.2022-01-04
NovaSure Impedance Controlled Endometrial Ablation System (P010013/S082)Hologic, Inc.2021-12-09
NovaSure Impedance Controlled Endometrial Ablation System (P010013/S086)Hologic, Inc.2021-11-15
Mara Water Vapor Ablation System (P160047/S025)CooperSurgical, Inc.2021-10-29
GYNECARE INTERCEED™ Absorbable Adhesion Barrier (P880047/S045)ETHICON, Inc.2021-10-29
GYNECARE INTERCEED™ Absorbable Adhesion Barrier (P880047/S044)ETHICON, Inc.2021-10-21
GYNECARE INTERCEED™ Absorbable Adhesion Barrier (P880047/S042)ETHICON, Inc.2021-09-10
Cerene Cryotherapy Device (P180032/S009)Channel Medsystems, Inc.2021-09-01
GYNECARE INTERCEED™ Absorbable Adhesion Barrier (P880047/S041)ETHICON, Inc.2021-08-31
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S084)Hologic, Inc.2021-08-30
Cerene Cryotherapy Device (P180032/S006)Channel Medsystems, Inc.2021-08-27
Cerene Cryotherapy Device (P180032/S008)Channel Medsystems, Inc.2021-07-26
Cerene Cryotherapy Device (P180032/S007)Channel Medsystems, Inc.2021-07-22
NovaSure Impedance Controlled Endometrial Ablation System (P010013/S081)Hologic, Inc.2021-06-30
Minerva Genesys HTA Endometrial Ablation System (P000040/S041)Axora Medical, Inc.2021-06-17
Mara Water Vapor Ablation System (P160047/S021)CooperSurgical, Inc.2021-06-09
Falope Ring Band and Applicator Systems (P870076/S027)Gyrus Acmi, Inc.2021-05-19
Falope-Ring® Band and Applicator Systems (P870076/S026)Gyrus Acmi, Inc.2021-05-11
Cerene® Cryotherapy Device (P180032/S005)Channel Medsystems, Inc.2021-04-27
GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S040)ETHICON, Inc.2021-04-21
Mara Water Vapor System (P160047/S023)CooperSurgical, Inc.2021-04-21
Mara Water Vapor Ablation System, Mara Water Vapor System, Mara Console (P160047/S024)CooperSurgical, Inc.2021-04-19
Mara Water Vapor Ablation System (P160047/S022)CooperSurgical, Inc.2021-04-12
GYNECARE INTECEED Adhesion Barrier (P880047/S039)ETHICON, Inc.2021-04-01
NovaSure Impedance Controlled Endometrial Ablation System (P010013/S083)Hologic, Inc.2021-03-30
Cerene Cryotherapy Device (P180032/S003)Channel Medsystems, Inc.2021-02-25
Cerene Cryotherapy Device (P180032/S004)Channel Medsystems, Inc.2021-02-23
Minerva Endometrial Ablation System (P140013/S012)Axora Medical, Inc.2021-02-17
Mara Water Vapor Probe (P160047/S020)CooperSurgical, Inc.2021-01-27
AEGEA Vapor System (P160047/S019)CooperSurgical, Inc.2021-01-14
AEGEA Vapor System (P160047/S017)CooperSurgical, Inc.2021-01-05
Hydro Thermablator Endometrial Ablation System (P000040/S040)Axora Medical, Inc.2020-12-17
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