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Obstetrics/Gynecology

632 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S023)Gynecare, Inc.2008-09-19
CONCEPTUS ESSURE SYSTEM (P020014/S020)Bayer Pharma AG2008-09-11
MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) (P020031/S003)Microsulis Medical , Ltd.2008-09-02
THE GYNECARE THERMACHOICE* III (P970021/S022)Gynecare, Inc.2008-08-25
THE GYNECARE THERMACHOICE* III (P970021/S021)Gynecare, Inc.2008-08-21
HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM (P000032/S025)CooperSurgical, Inc.2008-07-16
ESSURE SYSTEM (P020014/S015)Bayer Pharma AG2008-06-10
HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM (P000032/S027)CooperSurgical, Inc.2008-05-30
GYNECARE THERMACHOICE 3 UTERINE BALLOON THERAPY SYSTEM (P970021/S019)Gynecare, Inc.2008-05-23
FEMCARE FILSHIE CLIP SYSTEM (P920046/S005)Femcare , Ltd.2008-05-15
GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S020)Gynecare, Inc.2008-05-14
HYSKON HYSTEROSCOPY FLUID 32% (W/V) DEXTRAN 70 IN DEXTROSE (N17511/S015)Coopervision Surgical2008-05-14
GYNECARE THERMACHOICE (P970021/S018)Gynecare, Inc.2008-05-12
COOK CHORIONIC VILLUS SAMPLING SET (P900007/S004)Cook Incorporated2008-05-08
HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM (P000032/S026)CooperSurgical, Inc.2008-04-16
NEOVENTA'S STAN S31 FETAL HEART MONITOR (P020001/S004)Neoventa Medical AB2008-04-11
HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S022)CooperSurgical, Inc.2008-03-21
STAN S31 FETAL HEART MONITOR (P020001/S005)Neoventa Medical AB2008-03-12
ADEPT ADHESION REDUCTION SOLUTION (P050011/S001)Baxter Healthcare Corp2008-02-07
HER OPTION OFFICE CRYOABLATION SYSTEM (P000032/S024)CooperSurgical, Inc.2008-02-04
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S019)Hologic, Inc.2008-02-01
GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S016)Gynecare, Inc.2008-01-29
HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM (P000032/S023)CooperSurgical, Inc.2007-12-20
GYNECARETHERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S015)Gynecare, Inc.2007-11-05
HTA SYSTEM (P000040/S012)Axora Medical, Inc.2007-11-02
STAN S31 FETAL HEART MONITOR (P020001/S002)Neoventa Medical AB2007-09-26
HTA SYSTEM (P000040/S010)Axora Medical, Inc.2007-08-08
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S014)Bayer Pharma AG2007-08-07
EXABLATE 2000, VERSION 4.22 (P040003/S004)Insightec, Ltd.2007-08-02
HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S021)CooperSurgical, Inc.2007-07-27
HTA SYSTEM (P000040/S011)Axora Medical, Inc.2007-07-16
GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S014)Gynecare, Inc.2007-07-06
STAN S31 FETAL HEART MONITOR (P020001/S001)Neoventa Medical AB2007-07-03
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S012)Bayer Pharma AG2007-06-15
ACMI FALOPE RING BAND (P870076/S008)Gyrus Acmi, Inc.2007-05-24
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S018)Hologic, Inc.2007-03-29
HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM (P000040/S009)Axora Medical, Inc.2007-03-23
EXABLATE 2000 (P040003/S002)Insightec, Ltd.2007-02-27
INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S011)ETHICON, Inc.2006-11-21
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S010)Bayer Pharma AG2006-10-11
NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S017)Hologic, Inc.2006-10-05
ESSURE PERMANENT BIRTH CONTROL SYSTEM (P020014/S013)Bayer Pharma AG2006-09-19
HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM (P000040/S007)Axora Medical, Inc.2006-08-18
HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S020)CooperSurgical, Inc.2006-08-15
ADEPT (4% ICODEXTRIN) ADHESION REDUCTION SOLUTION (P050011)Baxter Healthcare Corp2006-07-28
HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S019)CooperSurgical, Inc.2006-07-28
INTERCEED (TC7) ABSORBABLE ADHESION BARRIER (P880047/S010)ETHICON, Inc.2006-07-03
HER OPTION CYROABLATION THERAPY SYSTEM (P000032/S013)CooperSurgical, Inc.2006-07-03
LUMA CERVICAL IMAGING SYSTEM (P040028/S002)Spectra Science2006-06-26
HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM (P000040/S008)Axora Medical, Inc.2006-06-23
NOVASURE IMPENDANCE CONTOLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S015)Hologic, Inc.2006-06-16
HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S018)CooperSurgical, Inc.2006-05-23
LUMA CERVICAL IMAGING SYSTEM (P040028/S001)Spectra Science2006-04-11
LUMA CERVICAL IMAGING SYSTEM (P040028)Spectra Science2006-03-16
FETAL ACOUSTIC STIMULATOR (P870025/S008)Ge Medical Systems, Inc.2006-03-02
HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S017)CooperSurgical, Inc.2006-02-16
FEMCAP CONTRACEPTIVE BARRIER DEVICE (P020041/S001)Femcap Incorporated2006-02-15
HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S016)CooperSurgical, Inc.2006-02-02
EXABLATE 2000 MRI GUIDED FOCUSED ULTRASOUND SYSTEM (P040003/S001)Insightec, Ltd.2005-12-30
STAN S31 FETAL HEART MONITOR (P020001)Neoventa Medical AB2005-11-01
MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM (P020031/S002)Microsulis Medical , Ltd.2005-10-14
HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM (P000040/S006)Axora Medical, Inc.2005-09-21
HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S012)CooperSurgical, Inc.2005-09-21
INTERCEED (TC7) ABSORBABLE ADHESION BARRIER (P880047/S009)ETHICON, Inc.2005-07-22
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S014)Hologic, Inc.2005-07-22
ESSURE SYSTEM (P020014/S009)Bayer Pharma AG2005-07-12
HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM (P000040/S005)Axora Medical, Inc.2005-07-12
HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S011)CooperSurgical, Inc.2005-06-30
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S012)Covidien, LLC2005-06-24
HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S009)CooperSurgical, Inc.2005-05-26
MICROSULIS MICROWAVE ENDOMETERIAL ABLATION (MEA) SYSTEM (P020031/S001)Microsulis Medical , Ltd.2005-05-25
HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S008)CooperSurgical, Inc.2005-04-22
NOVASURE GLOBAL IMPENDENCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S012)Hologic, Inc.2005-03-24
COROMETRICS MODEL 146-FETAL ACOUSTIC STIMULATOR (P870025/S007)Ge Medical Systems, Inc.2005-03-24
HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S006)CooperSurgical, Inc.2005-03-21
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S011)Hologic, Inc.2005-03-07
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S011)Covidien, LLC2005-02-25
ESSURE SYSTEM (P020014/S008)Bayer Pharma AG2005-01-31
GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S012)Gynecare, Inc.2005-01-03
HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S005)CooperSurgical, Inc.2004-11-09
EXABLATE 2000 SYSTEM (P040003)Insightec, Ltd.2004-10-22
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S010)Hologic, Inc.2004-09-09
GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S011)Gynecare, Inc.2004-08-23
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S008)Hologic, Inc.2004-08-13
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S009)Hologic, Inc.2004-08-02
ESSURE SYSTEM (P020014/S006)Bayer Pharma AG2004-07-22
ESSURE SYSTEM (P020014/S005)Bayer Pharma AG2004-06-10
LEA'S SHIELD BARRIER CONTRACEPTIVE (P010043/S001)Yama, Inc.2004-05-26
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S007)Bayer Pharma AG2004-04-08
HER OPTION CYROABLATION THERAPY SYSTEM (P000032/S004)CooperSurgical, Inc.2004-03-31
HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM (P000040/S004)Axora Medical, Inc.2004-02-24
NOVASURE IMPEDENCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S006)Hologic, Inc.2004-02-05
GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S009)Gynecare, Inc.2003-12-22
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S007)Hologic, Inc.2003-12-05
GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S010)Gynecare, Inc.2003-12-02
INTERCEED (TC7) ABSORBABLE ADHESION BARRIER (P880047/S008)ETHICON, Inc.2003-10-21
COROMETRICS MODEL 120 F-SERIES MATERNAL/FETAL MONITOR WITH INTERGRATED FETAL OXYGEN SATURATION MONITORING (P000016/S002)Ge Medical Systems Information Technologies2003-10-15
MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM (P020031)Microsulis Medical , Ltd.2003-09-23
HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S003)CooperSurgical, Inc.2003-08-08
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S004)Bayer Pharma AG2003-07-17
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