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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/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
EXABLATE (P040003/S015)Insightec, Ltd.2015-08-31
MINERVA ENDOMETRIAL ABLATION SYSTEM (P140013)Axora Medical, Inc.2015-07-27
GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S021)ETHICON, Inc.2015-07-21
ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S041)Bayer Pharma AG2015-06-29
NOVASURE IMPEDENCE CONTROLLED ABLATION SYSTEM (P010013/S063)Hologic, Inc.2015-06-15
ESSURE SYSTEM (P020014/S043)Bayer Pharma AG2015-06-09
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S062)Hologic, Inc.2015-03-19
FALOPE-RING BAND APPLICATOR KITS (P870076/S016)Gyrus Acmi, Inc.2015-02-19
HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S042)CooperSurgical, Inc.2014-12-18
ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S042)Bayer Pharma AG2014-12-11
GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S042)Gynecare, Inc.2014-12-04
DISPOSABLE FALOPE RING BAND APPLICATOR KITS (P870076/S015)Gyrus Acmi, Inc.2014-12-04
GENESYS HTA SYSTEM (P000040/S034)Axora Medical, Inc.2014-11-25
FALOPE-RING BAND AND APPLICATOR SYSTEMS (P870076/S014)Gyrus Acmi, Inc.2014-11-17
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S061)Hologic, Inc.2014-11-12
NOVASURE IMPEDANCE CONTROLLED EDOMETRIAL ABLATION SYSTEM (P010013/S058)Hologic, Inc.2014-10-28
GENESYS HTA SYSTEM (P000040/S033)Axora Medical, Inc.2014-10-21
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S060)Hologic, Inc.2014-10-06
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM/ ABLATION SYSTEM WITH SURESOUND UTERINE SOUND (P010013/S059)Hologic, Inc.2014-09-09
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S057)Hologic, Inc.2014-06-19
EXABLATE SYSTEM (P040003/S014)Insightec, Ltd.2014-06-13
GENESYS HTA SYSTEM (P000040/S032)Axora Medical, Inc.2014-06-10
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM, NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL SYSTEM WITH SURE (P010013/S056)Hologic, Inc.2014-06-04
NOVASURE IMPEDENCE CONTROLLED ABLATION SYSTEM (P010013/S054)Hologic, Inc.2014-05-30
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S055)Hologic, Inc.2014-05-14
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S047)Hologic, Inc.2014-04-25
NOVASURE MODEL 10 RADIOFREQUENCY CONTROL UNIT (P010013/S051)Hologic, Inc.2014-04-22
GYNECARE THERMACHOICE UTERINE BALLON THERAPY SYSTEM (P970021/S041)Gynecare, Inc.2014-04-09
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION DEVICE (P010013/S053)Hologic, Inc.2014-03-26
GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM (P970021/S040)Gynecare, Inc.2014-03-17
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S052)Hologic, Inc.2014-02-25
GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM (P970021/S039)Gynecare, Inc.2014-02-24
EXABLATE 2000/2100 (P040003/S013)Insightec, Ltd.2013-12-16
GENESYS HTA SYSTEM (P000040/S031)Axora Medical, Inc.2013-12-11
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S050)Hologic, Inc.2013-11-08
ESSURE (P020014/S040)Bayer Pharma AG2013-10-30
ADEPT ADHESION REDUCTION SOLUTION (4% ICODEXTRIN) (P050011/S005)Baxter Healthcare Corp2013-10-29
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S049)Hologic, Inc.2013-10-10
FEMCAP (P020041/S003)Femcap Incorporated2013-08-21
NOVASURE IMPEDANCE CONTROLLED ENDOMETERIAL ABALTION SYSTEM (P010013/S048)Hologic, Inc.2013-08-20
GENESYS HTA SYSTEM (P000040/S029)Axora Medical, Inc.2013-08-14
GENESYS HTA SYSTEM (P000040/S030)Axora Medical, Inc.2013-07-19
HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S041)CooperSurgical, Inc.2013-07-15
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM, & WITH SURESOUND ULTRINE SOUND, NOVASURE RF CONTROLLER 115V (P010013/S046)Hologic, Inc.2013-07-10
GENESYS HTA SYSTEM (P000040/S028)Axora Medical, Inc.2013-07-09
ADEPT ADHESION REDUCTION SOLUTION (4% ICODEXTRIN) (P050011/S004)Baxter Healthcare Corp2013-07-02
GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM (P970021/S038)Gynecare, Inc.2013-06-20
GENESYS HTA SYSTEM (P000040/S027)Axora Medical, Inc.2013-05-16
GYNECARE THERMACHOICE III UTERINE THERAPY SYSTEM (P970021/S037)Gynecare, Inc.2013-04-03
HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S040)CooperSurgical, Inc.2013-03-14
GYNECARE INTERCEED ABSORABLE ADHESION BARRIER (P880047/S020)ETHICON, Inc.2013-03-12
HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S039)CooperSurgical, Inc.2013-03-05
HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM (P000032/S038)CooperSurgical, Inc.2013-02-06
NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S041)Hologic, Inc.2013-02-01
GENESYS HTA SYSTEM (P000040/S026)Axora Medical, Inc.2013-01-11
ESSURE SYSTEM (P020014/S039)Bayer Pharma AG2012-12-20
NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S045)Hologic, Inc.2012-11-15
FALOPE-RING CAND AND APPLICATOR SYSTEMS (P870076/S013)Gyrus Acmi, Inc.2012-10-26
GENESYS HTA SYSTEM (P000040/S025)Axora Medical, Inc.2012-10-24
COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR, 0146 (P870025/S011)Ge Medical Systems, Inc.2012-10-10
CONCEPTUS ESSURE SYSTEM (P020014/S038)Bayer Pharma AG2012-10-02
EXABLATE SYSTEM (P040003/S012)Insightec, Ltd.2012-09-07
DISPOSABLE FALOPE-RING BAND APPLICATOR KITS (P870076/S012)Gyrus Acmi, Inc.2012-07-05
GENESYS HTA SYSTEM (P000040/S024)Axora Medical, Inc.2012-06-19
CONCEPTUS ESSURE SYSTEM (P020014/S037)Bayer Pharma AG2012-05-17
ADEPT ADHESION REDUCTION SOLUTION (P050011/S003)Baxter Healthcare Corp2012-05-17
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S043)Hologic, Inc.2012-05-03
EXABLATE DEVICE (P040003/S011)Insightec, Ltd.2012-05-01
GENESYS HTA SYSTEM (P000040/S021)Axora Medical, Inc.2012-04-23
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S036)Bayer Pharma AG2012-04-19
GYNECAR INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S019)ETHICON, Inc.2012-04-10
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S028)Hologic, Inc.2012-03-28
ADIANA CONTRACEPTION SYSTEM (P070022/S025)Hologic, Inc.2012-03-20
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S035)Bayer Pharma AG2012-03-19
GENESYS HTA SYSTEM (P000040/S023)Axora Medical, Inc.2012-02-29
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S017)Bayer Pharma AG2012-02-24
CONCEPTUS ESSURE SYSTEM (P020014/S033)Bayer Pharma AG2012-02-22
GENESYS HTA SYSTEM (P000040/S022)Axora Medical, Inc.2012-02-14
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S026)Hologic, Inc.2012-02-09
GENESYS HTA SYSTEM (P000040/S020)Axora Medical, Inc.2012-01-24
NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S042)Hologic, Inc.2011-12-20
GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S018)ETHICON, Inc.2011-12-14
EXABLATE (P040003/S010)Insightec, Ltd.2011-12-08
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S024)Hologic, Inc.2011-11-23
STAN S31 FETAL HEART MONITOR (P020001/S009)Neoventa Medical AB2011-11-18
HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S037)CooperSurgical, Inc.2011-11-03
FEM CAP (P020041/S002)Femcap Incorporated2011-10-13
FETAL ACOUSTIC STIMULATOR (P870025/S010)Ge Medical Systems, Inc.2011-10-12
HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S036)CooperSurgical, Inc.2011-10-12
HTA SYSTEM (P000040/S019)Axora Medical, Inc.2011-10-03
GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM (P970021/S036)Gynecare, Inc.2011-09-23
FC2 FEMALE CONDOM (P080002/S001)Clear Future, Inc.2011-09-23
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S014)Hologic, Inc.2011-09-06
GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S017)ETHICON, Inc.2011-08-18
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