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Obstetrics/Gynecology

632 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
Cerene Cryotherapy Device (P180032/S002)Channel Medsystems, Inc.2020-11-18
AEGEA Water Vapor Ablation System (P160047/S016)CooperSurgical, Inc.2020-11-10
GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S038)ETHICON, Inc.2020-11-04
NovaSure Impedance Controlled Endometrial Ablation System (P010013/S080)Hologic, Inc.2020-10-27
Mara Vapor System (P160047/S015)CooperSurgical, Inc.2020-10-20
Mara Vapor System (P160047/S014)CooperSurgical, Inc.2020-10-20
NovaSure Impedance Controlled Endometrial Ablation System (P010013/S079)Hologic, Inc.2020-10-19
Mara Water Vapor Ablation System, Mara Water Vapor System, Mara Console (P160047/S013)CooperSurgical, Inc.2020-09-14
ADEPT Adhesion Reduction Solution (P050011/S008)Baxter Healthcare Corp2020-08-21
Hydro Thermablator Endometrial Ablation System (P000040/S039)Axora Medical, Inc.2020-07-30
Mara Water Vapor Ablation System (P160047/S012)CooperSurgical, Inc.2020-07-21
GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S037)ETHICON, Inc.2020-07-15
Cerene Cryotherapy Device (P180032/S001)Channel Medsystems, Inc.2020-07-08
Falope Ring Bands (P870076/S025)Gyrus Acmi, Inc.2020-07-02
Mara Water Vapor Ablation System, Mara Water vapor Probe, Mara Console (P160047/S011)CooperSurgical, Inc.2020-07-01
ADEPT Adhesion Reduction Solution (P050011/S007)Baxter Healthcare Corp2020-07-01
Mara Water Vapor Ablation System (P160047/S008)CooperSurgical, Inc.2020-06-17
GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S036)ETHICON, Inc.2020-05-21
GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S035)ETHICON, Inc.2020-05-20
Hydro Thermablator Endometrial Ablation System (P000040/S038)Axora Medical, Inc.2020-05-19
Mara Water Vapor Ablation System (P160047/S010)CooperSurgical, Inc.2020-05-06
NovaSure Impedance Controlled Endometrial Ablation System (P010013/S075)Hologic, Inc.2020-03-02
Trocar Knife (P870076/S024)Gyrus Acmi, Inc.2020-02-12
Minerva Endometrial Ablation System (P140013/S011)Axora Medical, Inc.2020-02-12
Gynecare Interceed Absorbable Adhesion Barrier (P880047/S034)ETHICON, Inc.2020-01-30
Mara Water Vapor System (P160047/S006)CooperSurgical, Inc.2020-01-16
MARA Water Vapor System (P160047/S005)CooperSurgical, Inc.2020-01-08
Gynecare Interceed Absorbable Adhesion Barrier (P880047/S033)ETHICON, Inc.2019-12-04
Mara Water Vapor Ablation System, Mara Water Vapor Probe Procedure Kit, Mara Water Vapor Probe, Mara Supply and Drain Ac (P160047/S007)CooperSurgical, Inc.2019-11-04
Filshie Clip (Mark VI) System (P920046/S011)Femcare , Ltd.2019-10-09
Novasure Impedance Controlled Endometrial Ablation System (P010013/S078)Hologic, Inc.2019-10-01
NovaSure Impedance Controlled Endometrial Ablation Device (P010013/S077)Hologic, Inc.2019-09-26
Hydro Thermablator Endometrial Ablation (P000040/S037)Axora Medical, Inc.2019-09-13
GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S032)ETHICON, Inc.2019-07-23
AEGEA Vapor System, Aegea Vapor Probe Procedure Kit, Aegea Vapor Generator and Aegea Vapor Generator Accessory Kit (P160047/S004)CooperSurgical, Inc.2019-06-14
ADEPT Adhesion Reduction Solution (P050011/S006)Baxter Healthcare Corp2019-06-03
GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S030)ETHICON, Inc.2019-05-13
GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S031)ETHICON, Inc.2019-04-12
Cerene® Cryotherapy Device (P180032)Channel Medsystems, Inc.2019-03-28
GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S029)ETHICON, Inc.2019-03-11
NovaSure Impedance Controlled Endometrial Ablation System (P010013/S073)Hologic, Inc.2019-03-01
GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S028)ETHICON, Inc.2019-01-10
NovaSure Impedance Controlled Endometrial Ablation System (P010013/S072)Hologic, Inc.2019-01-09
AEGEA Vapor System, AEGEA Vapor Probe Procedure Kit, AEGEA Vapor Generator, AEGEA Vapor Generator Accessory Kit (P160047/S001)CooperSurgical, Inc.2018-12-06
AEGEA VAPOR SYSTEM, AEGEA VAPOR PROBE PROCEDURE KIT, AEGEA VAPOR GENERATOR AND AEGEA VAPOR GENERATOR ACCESSORY KIT (P160047/S003)CooperSurgical, Inc.2018-11-29
AEGEA Vapor System (P160047/S002)CooperSurgical, Inc.2018-09-25
Exablate 2100/2100V1 System (P040003/S021)Insightec, Ltd.2018-08-16
NovaSure Impedance Controlled Endometrial Ablation System (P010013/S071)Hologic, Inc.2018-07-25
Her Option Office Cryoablation Therapy System (P000032/S043)CooperSurgical, Inc.2018-07-11
Minerva Endometrial Ablation System (P140013/S010)Axora Medical, Inc.2018-06-21
NovaSure Impedance Controlled Endometrail Ablation Device (P010013/S070)Hologic, Inc.2018-05-17
Minerva Endometrial Ablation System (P140013/S009)Axora Medical, Inc.2018-05-01
Essure System for Permanent Birth Control (P020014/S051)Bayer Pharma AG2018-04-09
Essure System for Permanent Birth Control (P020014/S050)Bayer Pharma AG2018-03-22
NovaSure Impedance Controlled Endometrial Ablation System (P010013/S069)Hologic, Inc.2018-01-12
Essure System for Permanent Birth Control (P020014/S049)Bayer Pharma AG2017-12-04
Minerva Endometrial Ablation System (P140013/S006)Axora Medical, Inc.2017-08-07
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S068)Hologic, Inc.2017-07-18
Gynecare Interceed Absorbable Adhesion Barrier (P880047/S027)ETHICON, Inc.2017-07-06
Genesys Hta 115V Control Unit, Genesys Hta 115V Control Unit (Demo), Genesys Hta 115V Control Unit (Refurb), Genesys Hta (P000040/S035)Axora Medical, Inc.2017-06-29
Minerva Endometrial Ablation System (P140013/S007)Axora Medical, Inc.2017-06-26
FC2 FEMALE CONDOM (P080002/S002)Clear Future, Inc.2017-06-23
MARA™ Vapor System, MARA™ Vapor Probe Procedure Kit, MARA™ Vapor Generator and MARA™ Vapor Generator Accessory Kit (P160047)CooperSurgical, Inc.2017-06-14
Sterishot II Mini Flishie Clip Applicator (P920046/S010)Femcare , Ltd.2017-05-26
Hydro Thermablator Endometrial Ablation System (P000040/S036)Axora Medical, Inc.2017-05-26
MINERVA ENDOMETRIAL ABLATION SYSTEM (P140013/S005)Axora Medical, Inc.2017-05-15
Gynecare Interceed Absorbable Adhesion Barrier (P880047/S026)ETHICON, Inc.2017-03-29
FALOPE RING BAND AND APPLICATOR SYSTEMS (P870076/S022)Gyrus Acmi, Inc.2017-02-21
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S067)Hologic, Inc.2017-01-10
ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S048)Bayer Pharma AG2016-12-14
FILSHIE CLIP(MARK VI) SYSTEM (P920046/S008)Femcare , Ltd.2016-12-02
ESSURE SYSTEM (P020014/S046)Bayer Pharma AG2016-11-15
MINERVA ENDOMETRIAL ABLATION SYSTEM (P140013/S004)Axora Medical, Inc.2016-11-09
InSightec ExAblate System (P040003/S019)Insightec, Ltd.2016-10-28
GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S025)ETHICON, Inc.2016-10-26
GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S022)ETHICON, Inc.2016-10-24
HULKA CLIP FOR TUBAL OCCLUSION (P870080/S002)Richard Wolf Medical Instruments Corp.2016-10-14
Essure System for Permanent Birth Control (Model ESS305) (P020014/S047)Bayer Pharma AG2016-09-29
GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S024)ETHICON, Inc.2016-09-27
Falope-Ring Band Contraceptive Tubal Occlusion System (P870076/S023)Gyrus Acmi, Inc.2016-09-23
MINERVA ENDOMETRIAL ABLATION SYSTEM (P140013/S003)Axora Medical, Inc.2016-09-21
GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S023)ETHICON, Inc.2016-09-20
FILSHIE CLIP (MARK VI) SYSTEM (P920046/S009)Femcare , Ltd.2016-09-09
MINERVA ENDOMETRIAL ABLATION SYSTEM (P140013/S002)Axora Medical, Inc.2016-08-30
EXABLATE 2000 SYSTEM (P040003/S018)Insightec, Ltd.2016-08-26
FALOPE-RING BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM (P870076/S017)Gyrus Acmi, Inc.2016-07-20
EXABLATE 2000 SYSTEM (P040003/S017)Insightec, Ltd.2016-06-27
ESSURE SYSTEM (P020014/S044)Bayer Pharma AG2016-05-12
ESSURE SYSTEM (P020014/S045)Bayer Pharma AG2016-04-28
FALOPE-RING BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM (P870076/S018)Gyrus Acmi, Inc.2016-03-22
DISPOSABLE FALOPE-RING BAND APPLICATOR KITS (P870076/S021)Gyrus Acmi, Inc.2016-03-02
MINERVA ENDOMETRIAL ABLATION SYSTEM (P140013/S001)Axora Medical, Inc.2016-02-23
DISPOSABLE FALOPE-RING BANK APPLICATOR KITS (P870076/S020)Gyrus Acmi, Inc.2016-02-09
DISPOSABLE FALOPE-RING BAND APPLICATOR KITS (P870076/S019)Gyrus Acmi, Inc.2016-01-27
GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S044)Gynecare, Inc.2016-01-04
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM. (P010013/S066)Hologic, Inc.2015-10-27
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S064)Hologic, Inc.2015-10-22
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S065)Hologic, Inc.2015-10-15
EXABLATE (P040003/S016)Insightec, Ltd.2015-10-05
GYNECARE THERMACHOICE II BALLOON CATHETER (P970021/S043)Gynecare, Inc.2015-10-02
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