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Obstetrics/Gynecology

632 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
NOVASURE IMPENDANCE CONROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S039)Hologic, Inc.2011-08-18
EXABLATE 2000/2100 1.5 AND 3T (P040003/S009)Insightec, Ltd.2011-08-09
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S020)Hologic, Inc.2011-08-09
NEOVENTA'S STAN S31 FETAL HEART MONITOR (P020001/S008)Neoventa Medical AB2011-08-04
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S021)Hologic, Inc.2011-07-26
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S013)Hologic, Inc.2011-07-05
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S034)Bayer Pharma AG2011-07-01
GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S016)ETHICON, Inc.2011-06-30
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S036)Hologic, Inc.2011-06-29
ADEPT ADHESION REDUCTION SOLUTION (4% ICODEXTRIN) (P050011/S002)Baxter Healthcare Corp2011-06-17
ABSORBABLE ADHESION BARRIER (P880047/S015)ETHICON, Inc.2011-06-17
GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S030)Gynecare, Inc.2011-06-13
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S019)Hologic, Inc.2011-05-27
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S035)Hologic, Inc.2011-05-10
ADIANA PERMANMENT CONTRACEPTION SYSTEM (P070022/S018)Hologic, Inc.2011-05-10
GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM (P970021/S035)Gynecare, Inc.2011-05-05
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S008)Hologic, Inc.2011-05-05
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S016)Hologic, Inc.2011-04-14
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S017)Hologic, Inc.2011-04-08
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S034)Hologic, Inc.2011-04-08
GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM (P970021/S034)Gynecare, Inc.2011-04-05
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S012)Hologic, Inc.2011-03-09
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S031)Hologic, Inc.2011-03-09
GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S014)ETHICON, Inc.2011-03-02
GYNECARE THERMACHOICE III UTERINE THERAPY SYSTEM (P970021/S033)Gynecare, Inc.2011-02-25
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S032)Bayer Pharma AG2011-02-24
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S032)Hologic, Inc.2011-02-18
GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S032)Gynecare, Inc.2011-02-16
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S010)Hologic, Inc.2011-02-16
GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S029)Gynecare, Inc.2011-01-19
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S033)Hologic, Inc.2011-01-07
GENESYS HTA SYSTEM (P000040/S018)Axora Medical, Inc.2010-12-23
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S009)Hologic, Inc.2010-12-21
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S007)Hologic, Inc.2010-12-15
GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM (P970021/S031)Gynecare, Inc.2010-11-23
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S006)Hologic, Inc.2010-10-07
HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM (P000032/S033)CooperSurgical, Inc.2010-09-22
HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM (P000032/S032)CooperSurgical, Inc.2010-09-02
EXABLATE (P040003/S008)Insightec, Ltd.2010-08-23
GENESYS/HTA SYSTEM (P000040/S017)Axora Medical, Inc.2010-08-20
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S004)Hologic, Inc.2010-07-28
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S030)Hologic, Inc.2010-07-21
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S005)Hologic, Inc.2010-07-21
GENESYS HTA SYSTEM (P000040/S015)Axora Medical, Inc.2010-07-16
FALOPE-RING BAND & APPLICATOR SYSTEMS (P870076/S011)Gyrus Acmi, Inc.2010-07-08
GENESYS HTA SYSTEM (P000040/S016)Axora Medical, Inc.2010-07-08
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S029)Hologic, Inc.2010-06-23
FALOPE-RING BAND AND APPLICATOR SYSTEMS (P870076/S010)Gyrus Acmi, Inc.2010-06-02
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S028)Hologic, Inc.2010-06-01
GYNECARE THERMACHOICE 3 UTERINE BALLOON THERAPY SYSTEM (P970021/S028)Gynecare, Inc.2010-05-13
FETAL ACOUSTIC STIMULATOR (FAST) (P870025/S009)Ge Medical Systems, Inc.2010-04-23
GENESYS HTA SYSTEM (P000040/S014)Axora Medical, Inc.2010-04-23
EXABLATE 2100 SYSTEM (P040003/S007)Insightec, Ltd.2010-04-19
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S002)Hologic, Inc.2010-04-15
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S029)Bayer Pharma AG2010-04-06
HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM (P000032/S035)CooperSurgical, Inc.2010-02-25
FALOPE-RING BAND AND APPLICATOR SYSTEMS (P870076/S009)Gyrus Acmi, Inc.2010-02-25
HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM (P000032/S034)CooperSurgical, Inc.2010-02-23
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S030)Bayer Pharma AG2010-02-15
STAN S31 SYSTEM (P020001/S007)Neoventa Medical AB2010-02-01
HER OPTION UTERINE CRYOABLATION THERAPY SYSTEM (P000032/S030)CooperSurgical, Inc.2010-01-20
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S026)Hologic, Inc.2010-01-12
HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM (P000032/S031)CooperSurgical, Inc.2010-01-07
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S027)Hologic, Inc.2010-01-07
EXABLATE 2100 SYSTEM (P040003/S006)Insightec, Ltd.2009-12-22
NEOVENTA'S STAN S31 FETAL HEART MONITOR (P020001/S006)Neoventa Medical AB2009-11-16
HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM (P000032/S029)CooperSurgical, Inc.2009-11-04
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S001)Hologic, Inc.2009-10-20
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S025)Hologic, Inc.2009-10-16
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S022)Hologic, Inc.2009-09-15
CONCEPTUS ESSURE SYSTEM (P020014/S024)Bayer Pharma AG2009-08-26
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S024)Hologic, Inc.2009-07-31
ESSURE SYSTEM (P020014/S026)Bayer Pharma AG2009-07-16
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022)Hologic, Inc.2009-07-06
INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S013)ETHICON, Inc.2009-06-24
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S027)Bayer Pharma AG2009-06-19
GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S027)Gynecare, Inc.2009-06-19
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S025)Bayer Pharma AG2009-06-11
HTA SYSTEM (P000040/S013)Axora Medical, Inc.2009-05-14
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S023)Hologic, Inc.2009-05-08
GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S026)Gynecare, Inc.2009-04-28
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S022)Bayer Pharma AG2009-04-20
COOK CHORIONIC VILLUS SAMPLING SET (P900007/S005)Cook Incorporated2009-04-02
HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM (P000032/S028)CooperSurgical, Inc.2009-03-27
CERVICAL IMAGING SYSTEM (P040028/S004)Spectra Science2009-03-19
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S018)Bayer Pharma AG2009-03-16
FC2 FEMALE CONDOM (P080002)Clear Future, Inc.2009-03-10
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S023)Bayer Pharma AG2009-03-09
COOK CHORIONIC VILLUS SAMPLING SET (P900007/S006)Cook Incorporated2009-03-05
EXABLATE 2000 SYSTEM (P040003/S005)Insightec, Ltd.2009-03-04
LUMA CERVICAL IMAGING SYSTEM (P040028/S003)Spectra Science2009-02-27
GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S025)Gynecare, Inc.2009-02-11
NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S020)Hologic, Inc.2009-02-06
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S021)Hologic, Inc.2009-02-04
FEMCARE FILSHIE CLIP (P920046/S006)Femcare , Ltd.2009-01-30
GYNECARE THERMACHOICE II (P970021/S024)Gynecare, Inc.2009-01-14
FEMCARE FILSHIE CLIP (P920046/S007)Femcare , Ltd.2009-01-08
INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S012)ETHICON, Inc.2008-11-26
ESSURE SYSTEM (P020014/S021)Bayer Pharma AG2008-11-07
ESSURE CONTRACEPTIVE TUBAL OCCLUSION DEVICE AND DELIVERY SYSTEM (P020014/S019)Bayer Pharma AG2008-10-08
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