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Obstetrics/Gynecology

632 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
GYNECARE THERMACHOICE II UTERINE BALLOON THERAPY SYSTEM (P970021/S008)Gynecare, Inc.2003-07-14
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S002)Bayer Pharma AG2003-07-01
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S005)Hologic, Inc.2003-05-27
THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S006)Gynecare, Inc.2003-05-07
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S003)Bayer Pharma AG2003-04-11
FEMCAP BARRIER CONTRACEPTIVE (P020041)Femcap Incorporated2003-03-28
GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM (P970021/S007)Gynecare, Inc.2003-03-27
GYNECARE INTERGEL ADHESION PREVENTION SOLUTION (P990015/S002)Lifecore Biomedical, Inc.2003-03-18
ESSURE SYSTEM (P020014/S001)Bayer Pharma AG2003-03-06
HYDRO-THERMABLATOR(HTA) ENDOMETRIAL ABLATION SYSTEM (P000040/S003)Axora Medical, Inc.2003-02-20
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S004)Hologic, Inc.2003-01-16
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S006)Covidien, LLC2003-01-07
SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING (P020028)Philips Medical Systems, Inc.2003-01-03
OXI FIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S009)Covidien, LLC2002-11-25
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S008)Covidien, LLC2002-11-25
NOVASURE IMPEDANCE CONTROLLED EMDOMETRIAL ABLATION SYSTEM (P010013/S003)Hologic, Inc.2002-11-25
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S010)Covidien, LLC2002-11-15
ESSURE SYSTEM (P020014)Bayer Pharma AG2002-11-04
DILAPAN-S (P840045/S006)Medicem Technology S.R.O2002-10-25
GYNECARE INTERGEL ADHESION PREVENTION SOLUTION (P990015/S001)Lifecore Biomedical, Inc.2002-07-09
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S005)Covidien, LLC2002-06-28
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S002)Hologic, Inc.2002-06-05
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S001)Hologic, Inc.2002-05-23
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S007)Covidien, LLC2002-04-18
LEA'S SHIELD BARRIER CONTRACEPTIVE (P010043)Yama, Inc.2002-03-14
OXIFIRST(TM) FETAL SENSOR FS14-SERIES (P990053/S002)Covidien, LLC2001-12-19
HYDRO THERMABLATOR. ENDOMETRIAL ABLATION SYSTEM (P000040/S002)Axora Medical, Inc.2001-12-07
INTERGEL ADHESION PREVENTION SOLUTION (P990015)Lifecore Biomedical, Inc.2001-11-16
COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S006)Ge Medical Systems, Inc.2001-11-09
COROMETRICS MODEL 120 SERIES MATERNAL/FETAL MONITOR W/INTEGRATED FETAL PULSE OXIMETRY (P000016/S001)Ge Medical Systems Information Technologies2001-11-09
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S003)Covidien, LLC2001-11-09
THERMACHOICE UTERINE BALLOON THERAPY SYSTEM (P970021/S005)Gynecare, Inc.2001-10-19
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S001)Covidien, LLC2001-10-05
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013)Hologic, Inc.2001-09-28
HER OPTION UTERINE CRYOBLATION THERAPY SYSTEM (P000032/S001)CooperSurgical, Inc.2001-09-07
HYSKON HYSTEROSCOPY FLUID (N17511/S014)Coopervision Surgical2001-08-17
HYDRO THERMABLATOR(R) ENDOMETRIAL ABLATION SYSTEM (P000040/S001)Axora Medical, Inc.2001-07-10
HER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM (P000032)CooperSurgical, Inc.2001-04-20
HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM (P000040)Axora Medical, Inc.2001-04-20
THERMA CHOICE UTERINE BALLON THERAPY SYSTEM (P970021/S004)Gynecare, Inc.2001-02-13
COROMETRICS 120F SERIES MATERNAL/FETAL MONITOR (P000016)Ge Medical Systems Information Technologies2001-02-09
THERMACHOICE UTERINE BALLOON THERAPY SYSTEM (P970021/S003)Gynecare, Inc.2000-08-14
COOK CHORIONIC VILLUS SAMPLING (CVS) SET (P900007/S002)Cook Incorporated2000-06-12
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053)Covidien, LLC2000-05-12
HYSKON HYSTEROSCOPY FLUID (N17511/S013)Coopervision Surgical2000-02-09
THERMA CHOICE UTERINE BALLOON THERAPY SYSTEM (P970021/S002)Gynecare, Inc.1999-11-02
LAMICEL OSMOTIC CERVICAL DILATOR (P820075/S009)Medtronic Xomed, Inc.1999-07-16
LAMICEL OSMOTIC CERVICAL DILATOR (P820075/S008)Medtronic Xomed, Inc.1999-07-09
INTERCEED*(TC7) ABSORBABLE ADHESION BARRIER (P880047/S007)ETHICON, Inc.1999-05-24
INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S006)ETHICON, Inc.1999-05-05
FALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM (P870076/S007)Gyrus Acmi, Inc.1999-03-02
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S008)Hospira, Inc.1999-01-29
COOK CHORIONIC VILLUS SAMPLING SET (P900007/S001)Cook Incorporated1998-07-08
HULKA CLIP FOR TUBAL OCCLUSION (P870080/S001)Richard Wolf Medical Instruments Corp.1998-03-12
THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM (P970021/S001)Gynecare, Inc.1998-03-06
INTERCEED TC7 ABSORBABLE ADHESION BARRIER (P880047/S005)ETHICON, Inc.1998-02-09
HYSKON (32% DEXTRAN 70) (N17511/S012)Coopervision Surgical1997-12-30
THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM (P970021)Gynecare, Inc.1997-12-12
FALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM (P870076/S006)Gyrus Acmi, Inc.1997-03-21
REALITY FEMALE CONDOM (P910064/S013)The Female Health Co.1997-03-07
FALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM (P870076/S005)Gyrus Acmi, Inc.1996-12-12
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S007)Hospira, Inc.1996-09-05
HULKA CLIP FOR TUBAL OCCLUSION (P870080)Richard Wolf Medical Instruments Corp.1996-09-05
FILSHIE CLIP (MARK VI) SYSTEM (P920046)Femcare , Ltd.1996-09-05
COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S005)Ge Medical Systems, Inc.1996-07-17
FALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM (P870076/S004)Gyrus Acmi, Inc.1996-06-14
FALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM (P870076/S003)Gyrus Acmi, Inc.1996-03-01
INTERCEED TC7 ABSORBABLE ADHESION BARRIER (P880047/S004)ETHICON, Inc.1996-02-08
COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S004)Ge Medical Systems, Inc.1996-02-01
INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S003)ETHICON, Inc.1996-01-18
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S006)Hospira, Inc.1996-01-04
LAMICEL(R) OSMOSTIC CERVICAL DILATOR (P820075/S007)Medtronic Xomed, Inc.1996-01-03
FALOPE-RING(R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM (P870076/S001)Gyrus Acmi, Inc.1996-01-02
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S003)Hospira, Inc.1995-12-15
REALITY FEMALE CONDOM (P910064/S011)The Female Health Co.1995-11-16
LAMICEL(R) OSSMOTIC CERVICAL DILATOR (P820075/S006)Medtronic Xomed, Inc.1995-10-10
REALITY FEMALE CONDOM (P910064/S012)The Female Health Co.1995-10-05
CAREFONE(TM)HOME UTERINE ACTIVITY MONITOR SYSTEM (P910063)Matria Healthcare, Inc.1995-09-29
SYSTEM 37 HOME UTERINE ACTIVITY MONITORING SYSTEM (P920038)Matria Healthcare, Inc.1995-09-29
REALITY FEMALE CONDOM (P910064/S010)The Female Health Co.1995-07-31
REALITY FEMALE CONDOM (P910064/S007)The Female Health Co.1995-07-31
REALITY FEMALE CONDOM (P910064/S008)The Female Health Co.1995-07-31
REALITY FEMALE CONDOM (P910064/S004)The Female Health Co.1995-07-24
REALITY FEMALE CONDOM (P910064/S001)The Female Health Co.1995-07-24
REALITY FEMALE CONDOM (P910064/S009)The Female Health Co.1995-07-24
REALITY FEMALE CONDOM (P910064/S006)The Female Health Co.1995-07-24
HYSKON (32% DEXTRAN 70) (N17511/S010)Coopervision Surgical1995-07-18
HYSKON (32% DEXTRAN 70) (N17511/S011)Coopervision Surgical1995-07-18
GENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM (HUAM) (P890063/S004)Matria Healthcare, Inc.1995-06-16
FEMIDOM (P940033)The Female Health Co.1995-04-14
COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S002)Ge Medical Systems, Inc.1995-04-13
COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S003)Ge Medical Systems, Inc.1995-04-13
REALITY FEMALE CONDOM (P910064/S003)The Female Health Co.1994-10-18
COOK CHORIONIC VILLUS SAMPLING SET (P900007)Cook Incorporated1994-09-30
REALITY FEMALE CONDOM (P910064/S005)The Female Health Co.1994-04-13
GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS. (P890063/S003)Matria Healthcare, Inc.1994-01-31
TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER (P890024/S005)Smiths Industries Medical Systems, Inc.1993-12-27
FALOPE RING BAND AND APPLICATOR SYSTEMS (P870076)Gyrus Acmi, Inc.1993-09-29
REALITY(TM) VAGINAL POUCH (P910064/S002)The Female Health Co.1993-07-09
F C FEMALE CONDOM (P910064)The Female Health Co.1993-05-07
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